WORD Standard Template - SCTO89636f99-c796-4d6d-803a-… · Web viewAccording to RIPA Article 15...

Financial Contributions to Research Infrastructures of National RelevanceAccording to RIPA Article 15 (3) lit. a to c

Application for the Funding Period 2017 to 2020

This application is based on the report the SCTO submitted on 27.11.2014 regarding the project “organisation of clinical research financed by the confederation as from 2017: Measures concerning SCTO/CTU network” and the consequent mandate to SCTO/SwissPedNet to develop nationally organised service pools/research infrastructures to all researchers independent of pathology and population.

Changes to the report are based on the follow up report, where a consolidated proposal by the SCTO and SAKK regarding five RIs has been presented.

A summary of the changes between the RIs presented in the above-mentioned initial report of 27.11.2014 and this application is given in appendix 1. The report itself is added as appendix 2.

Swiss Clinical Trial Organisation SCTOPetersplatz 13

4051 Basel

T +41 61 260 10 40 | F +41 61 260 10 49 | [email protected] | www.scto.ch

Payment address: Petersplatz 13 | 4051 Basel

Auditor*: Heinz Glättli, member of the fiduciary chamber, Basel

Managing Director: Annette Magnin | F +41 61 260 10 41 | [email protected]

Activities: Research (R+D) 0%

Education 20%

Services 80%

Others 0%

* the Steering Board decided that (in agreement with the SERI) from 2017 onwards a large trust company will be appointed to cope with the new financial situation.

Financial Contributions to Research Infrastructures of National Relevance according to RIPA Art. 15for the fund Application for the funding period 2017 to 2020

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Table of contents1. The Swiss Clinical Trial Organisation and the network of CTUs.........................................................21.1 Bylaws, business rules and specifications of the governing bodies............................................................................2

1.1.1 Organisational chart....................................................................................................................................................................31.1.2 Flow of funds...............................................................................................................................................................................41.1.3 Performance evaluation..............................................................................................................................................................5

1.2 Members of the management, steering board, scientific advisory board....................................................................51.2.1 Steering Board (as per General Assembly 2015)........................................................................................................................51.2.2 Board of CTU Directors...............................................................................................................................................................51.2.3 Advisory Board (as per General Assembly 2015)........................................................................................................................51.2.4 SCTO Executive Office...............................................................................................................................................................5

1.3 Personnel (FTEs, Tasks, Qualifications).....................................................................................................................5

2. Current activities and multi-annual programme...................................................................................72.1 Today’s goals, targets and activities of the SCTO and the network of CTUs..............................................................7

2.2 Proposed research infrastructures (RIs) for the period 2017 to 2020.........................................................................82.2.1 National Safety Office..................................................................................................................................................................92.2.2 Quality Management.................................................................................................................................................................102.2.3 Regulatory Affairs (RA) pool......................................................................................................................................................122.2.4 Education..................................................................................................................................................................................132.2.5 National Pool for Data Management/IT.....................................................................................................................................152.2.6 National Pool for Biostatistics and Methodology........................................................................................................................152.2.7 Project Management Network...................................................................................................................................................162.2.8 International Network Collaboration Office................................................................................................................................172.2.9 SCTO Executive Office.............................................................................................................................................................182.2.10 Clinical Paediatric Hubs / SwissPedNet....................................................................................................................................192.2.11 Other innovative new approach.................................................................................................................................................21

3. Financial plan for the period 2017 to 2020..........................................................................................223.1 Overview of necessary expenditures, financial situation and the requested federal funds.......................................22

3.1.1 Budget for the proposed new research infrastructures of the SCTO/CTU network...................................................................223.1.2 Budget for the proposed new research infrastructure SwissPedNet..........................................................................................223.1.3 Budget for innovative approaches.............................................................................................................................................223.1.4 Grand Total...............................................................................................................................................................................22

3.2 Financial contributions by cantons, public institutions, academia and private foundations.......................................233.2.1 In-kind contributions of the SCTO/CTU network........................................................................................................................233.2.2 Confirmed in-kind contribution of the SwissPedNet...................................................................................................................233.2.3 Confirmed in-kind contribution for IT for access to clinical data (CHUV)...................................................................................233.2.4 Grand Total...............................................................................................................................................................................23

3.3 Distribution of funds within the SCTO/CTU network.................................................................................................23

4. Contribution to the Swiss research and innovation system..............................................................244.1 What are the national meaning and the additional benefit from a national perspective?..........................................24

4.2 In what way does this proposal complete tasks that are not accomplished by universities or other already federally funded institutions?...............................................................................................................................................24

4.3 Reasons for the confederation to support the proposed research infrastructures....................................................25

4.4 Present track record: most important current publications and other achievements.................................................25

5. Type specific requirements: Non-commercial RIs (scientific services)...........................................255.1 Association or networking with one or more universities...........................................................................................25

5.2 Access to the RIs and how far will it be used nationally or from abroad by the research community.......................255.2.1 Open access “one-stop-shop”...................................................................................................................................................255.2.2 Workflow within the network of CTUs........................................................................................................................................26

5.3 Further future fields of activities and potential contributions of the SCTO................................................................285.3.1 Collaboration with other partners/infrastructures.......................................................................................................................285.3.2 Other relevant infrastructures for clinical research....................................................................................................................28

6. Appendices............................................................................................................................................ 28

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1. The Swiss Clinical Trial Organisation and the network of CTUs

1.1 Bylaws, business rules and specifications of the governing bodiesThe legal form of the organisation is an association (with institutions being members) and is considered to be adequate also in future. The bylaws have been adopted during the founding assembly on 12 August 2009 and revised on 14 September 2012 in unison by the General Assembly/Steering Board (see appendix 3).

A decentralised structure with pathology-unspecific CTUs and a national coordination via SCTO already proved to be a good solution for clinical researchers and is a starting point for a national service pool. Such a decentralised organisation requires a well-defined governance structure with a very clear decision process and an adequate level of supervision, while maintaining the lean structure of the governing body.

A retreat of the SCTO Steering Board was dedicated to the current (-2016) and future (2017-) governance structure of the SCTO. An external governance expert is guiding the SB through this process and will support the Executive Office with the elaboration and implementation of the agreed changes.

General Assembly (GA) = Steering Board (SB) (delegated by member institutions): Main task: strategic decisions and authority to give directives. Composition and power of the GA/SB as per current bylaws proved to be adequate and powerful. Legal advice assured with representation of a legal department head of a member institution. SwissPedNet included, for the time being as observer, as of 2017 as an additional voting member. As of 2017 patient representation included as non-voting member. Specific know-how (e.g. IT etc.) to be consulted on a case-by-case basis.

President of the organisation: Officially represents the SCTO and the Steering Board. Gets more competencies in future, a job

description will be finalised by end of 2016, where also the role and responsibility of the vice-president will be considered.

Fixed, clearly defined, substantial and permanent contribution to ensure availability and visibility

Advisory Board (AB): Complements missing skills and views and advises the SB in its strategic decisions Is well balanced and operates professionally (with a defined final composition and method of

operation).

External (financial) supervision and controlling: Verifies performance (as per strategy and service level agreement with SERI), controls cash flow. Function outsourced to guarantee maximal transparency and independence. Procedure and profile clearly specified.

Board of CTU Directors (BCD): Decides how the SCTO strategy is implemented at CTU level and initiates its execution. Advises the SB (by creating concepts, budgets etc.) for specific strategic decisions to be taken. Is a permanent effective and efficient body representing high-level expertise in clinical research. Supports harmonization processes in order to facilitate (inter)national multicentre clinical trials.

Executive Office (EO): Executes the decisions of the Steering Board. Lean and flexible organisation: the team should grow to a maximum of 6 FTEs (today: 4.1 FTE). The Managing Director gets more competencies (reflected in job profile and standing

orders/business rules of the SCTO).

SCTO task forces: Permanent and ad hoc task forces with experts, moderated by the SCTO. Establish, implement, train and maintain nation-wide best practice (quality assurance, data

management, education etc.), drafts position papers as directed by the SB or requested by authorities.

Prepare concepts released and adopted by the SB or BCD before implementation to ensure that priorities and activities are in line with the SCTO’s overall strategy

Associate members / other service providers contributing to service pools



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The Steering Board considers the existing concept of the SCTO associate membership as a good way to collaborate with other institutions/service providers in future. This concept will ensure harmonisation and a standardised level of quality. Currently the Swiss Paraplegic Centre is associate member of the SCTO. The CTU Ticino is under evaluation to become member.

Collaboration with SAKK: the SB confirms the willingness for a closer collaboration with SAKK under jointly agreed conditions. However, since recently corresponding efforts failed, time seems not yet ripe for a formal organisational link. The SCTO highly welcomes the SAKK representatives in the permanent task forces and their contribution to activities promoted by SCTO (e.g. EUPATI). Furthermore, the Managing Directors of the two organisations still meet and exchange on a regular informal basis. This level of collaboration will be maintained and the SCTO will participate to future initiatives exploring further long-term synergies between SAKK and SCTO/CTU network.

For most bodies mentioned above, bylaws or rules of procedures are in place (available on request) and may need to be adapted for future purposes.

1.1.1 Organisational chart

The chart below illustrates the structure and composition of the future organisation. The following table gives an overview on the size of boards and bodies of the SCTO.

Chart 1: Organisational Chart SCTO as of 2017



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Board/body Function/main task Number/size/explanationsGeneral Assembly / full members

Develop and set strategy 9 institutions/organisations

Steering Board Develop and set strategy 10 voting delegates (one per institution + legal person/treasurer)2-3 non-voting delegates

Advisory Board Consult and complement 7 organisations (some with double staffing)Board of CTU Directors

Propose and execute strategy 6 CTU directors (some with double staffing)

Executive Office Execute strategy Number of FTEs:Total: 5.9 FTEsPresident: 20%, Managing Director: 100%, Administration: 100% Scientific Officers/PMs: 170%, Coordination of networks and partners (e.g. SwissPedNet, ECRIN): 100%, Communication Officer: 100%, (Financial Officer/Auditing: outsourced)

Permanent and ad-hoc task forces

Harmonise and establish best practicesDraft position papers and expert reports

In order to ensure a national harmonisation and understanding of best practice, permanent and ad hoc task forces with experts from different fields meet on a regular basis (as a general rule 3-4 meetings/y). Furthermore, ad-hoc taskforces execute position papers and statements responding to current priorities. They are composed of experts from the CTU network as well as representatives from associate members and partner organisations (e.g. SAKK).The size of the task forces depends on the topic.The output of these task forces is published with open access for everyone.Example for best practice output: Guidelines for Good Operational Practice (GGOP), Data Management Guidelines, Risk-adapted Monitoring Guidance, etc.

1.1.2 Flow of funds

The following procedure and chart is a suggestion of the SCTO. As per FIFG/LERI, funds received from the Federation will be distributed and controlled via the SCTO. The final distribution and reporting mechanism needs to be negotiated and defined with the SERI.

As mentioned above, the SCTO will outsource the financial supervision and controlling tasks for the sake of independence and transparency. Clear rules for distribution and controlling will be set and all steering board members will sign these rules in advance as a confirmation of their agreement.

Chart 2: Overview on the flow of funds



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1.1.3 Performance evaluation

The final outcome of the proposed RIs and WPs should be an increased activity and quality of IITs creating better evidence for existing and future medical therapies. The SB decided to appoint a task force with experts (not only from CTUs), suggesting metrics and processes to evaluate the future performance of the service pool. The aim would be to have the performance evaluation process in place by end of 2016.

1.2 Members of the management, steering board, scientific advisory board

1.2.1 Steering Board (as per General Assembly 2015)

Prof Claudio L. Bassetti, Swiss Academy of Medical Sciences (SAMS)

Prof Matthias Gugger, University Hospital Bern, Inselspital

Prof Klaus W. Grätz, Collège des Doyens

Prof Burkhard Ludewig, Cantonal Hospital St. Gallen

Prof Vincent Mooser, University Hospital Lausanne CHUV

Prof Christiane Pauli-Magnus, University Hospital Basel, Vice-president

Prof Arnaud Perrier, University Hospital Geneva HUG

Dr iur Vital Zehnder, University Hospital Zurich, Treasurer

Prof Gregor Zünd, University Hospital Zurich, President

Observer: Prof David Nadal, President SwissPedNet

1.2.2 Board of CTU Directors

Dr Thomas Fabbro, CTU Basel

Dr med Sven Trelle, CTU Bern

Prof Jérôme Pugin, Dr Françoise Lascombes, CRC Geneva

Dr med Grégoire Wuerzner, CRC Lausanne

Prof Christoph Driessen, Dr Reinhard Maier, CTU St. Gallen

PD Dr med Gabriela Senti, CTC Zurich

1.2.3 Advisory Board (as per General Assembly 2015)

Dr Mirjam Eglin, Swiss Association of Pharmaceutical Professionals (SwAPP)

Dr med Regina Grossmann, Swiss Association of Pharmaceutical Medicine (SGPM)

PD Dr med Alexander Jetter, Swiss Society for Clinical Pharmacology and Toxicology (SGKPT)

Dr Stephan Maack, Dr Simon Rotzler, Interpharma Clinical Research Working Group

Dr iur Jürg Müller, swissethics

Dr Andreas Pfenninger, Interpharma

Martin Pranjic, Jürg Granwehr, scienceindustries

Dr Aysim Yilmaz, Swiss National Science Foundation (SNSF)

1.2.4 SCTO Executive Office

Annette Magnin, Managing Director

1.3 Personnel (FTEs, Tasks, Qualifications)The network of CTUs employs xy FTEs. The staff includes senior scientists and scientists from various disciplines (e.g. physicians, statisticians, biologists, pharmacists), research associates, study coordinators (with different backgrounds), study nurses, monitors and administrative staff. (Descriptions of the tasks see section 2.)

The SCTO executive office (EO) currently employs 4.1 FTEs:



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Managing Director (0.9)

Quality Assurance / Education (0.6)

Data Management / ECRIN European Correspondent for Switzerland (0.8)

Network coordination / deputy Managing Director (0.8)

Administrative Assistant / Translations (0.6)

Accounting / General Administration (0.4)



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2. Current activities and multi-annual programme

2.1 Today’s goals, targets and activities of the SCTO and the network of CTUsThe SCTO is the umbrella organisation of the six Clinical Trial Units (CTUs) in Basel, Bern, Geneva, Lausanne, St Gallen and Zurich. This network provides professional services and support to researchers in the planning, implementation, conduct and evaluation of studies. By promoting a nationally harmonised culture of high-quality clinical research, the SCTO is striving to successfully position its members on a national and international level as the primary access point for clinical research in Switzerland and is increasingly recognised as the contact point to facilitate access to clinical research infrastructures in the country.

Indicators CTUs (activities 2014)

CTU network Number of studies supported > 500

Number of CTUs 6 Monocentric / - multicentric 50%Number of staff 165 International studies 10%Full Time Equivalents (FTEs) 91 IITs 95%

Services to studies > 1500 Education offer1Study consultations 2+++ Number of trainings provided 147Monitoring (incl QA, QM, audits) ++ Number of participants in training > 3500Biostatistics ++ (including e-learning)Data management ++Regulatory affairs ++ 1methodology, budget, feasibility…Project & onsite management + 2+ (<5%), ++ (>10%), +++ (>20%)

In accordance with the service agreement with the Swiss National Science Foundation (SNSF), the SCTO focuses on the coordination of the CTUs and on harmonised approaches in clinical research in Switzerland. Permanent working groups, composed of representatives of the CTUs, the Swiss Group for Clinical Cancer Research (SAKK) and the SCTO, elaborate joint projects in quality management, data management and continued education.

The CTU network of the SCTO takes the lead as provider of standardised and high-quality services in clinical research in the academic environment and in the academic-industrial cooperation in Switzerland. The CTUs as multidisciplinary study centres serve as focal points for researchers and assist in the planning, implementation, conduct, and evaluation of clinical studies. They have formed a well-established and nationally coordinated network and are the largest provider of services in clinical research in Switzerland. The SCTO establishes and further strengthens permanent subject-specific working groups to harmonise services and to enhance the coordination and cooperation within the CTU network.

The CTU network is the largest provider for training and continuous education for clinical research professionals in Switzerland. The SCTO supports the maintenance and expansion of the training offer of the CTU network. The CTU network strengthens its role as major provider of trainings in clinical research, thus supporting well-trained and qualified personnel who are aware of the latest developments in the field.

The SCTO and the CTU network support the academic environment in the implementation of best practice in clinical research. The Quality Assurance Working Group put a lot of effort into adjustments of the publicly available national Guidelines for Good Operational Practice (GGOP) to reflect changes based on the Human Research Act (HRA) and its ordinances, which came into force in 2014. Moreover, the SCTO and the CTU network were involved in several national projects implementing the new legislation and its associated new processes, focusing on minimum effort for maximum gain. In response to increased needs for GCP auditor capacities and know-how within the CTU network, the Quality Assurance Working Group has introduced the concept of an auditor pool. Professional auditing capacities and competencies within the CTU network shall be gradually build up and for this the delegates of the CTUs attended a first joint training in 2014.

The SCTO is the national and international contact point responsible for all aspects of clinical research in the academic environment in Switzerland. The SCTO is represented in relevant working groups, organisations and authority meetings, and maintains national and international contacts in the field of clinical research. The overall aim is to continuously improve the environment for clinical trials in Switzerland by simplifying processes and facilitating the performance in order to remain an attractive place for clinical research. The



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SCTO and the CTUs continue to be involved in national consultations and roundtable discussions relevant for clinical research.

The SCTO is the leading national platform for (clinical) researchers, industry, authorities and the public in Switzerland. By organising its annual Forum “Clinical Research” the annual Symposium and by co-organising many other events, the SCTO addresses important stakeholders in clinical research.

European Patients' Academy on Therapeutic Innovation (EUPATI): The SCTO is boosting the launch of a national EUPATI platform in Switzerland to allow patients to become trained and more involved in the development process of innovative therapies. First national events were organised by the Swiss EUPATI platform in 2014/2015 and provided an excellent opportunity for an exchange between representatives from patient organisations, academia, pharmaceutical industry and authorities.

See also SCTO Short Report 2014 (appendix 4).

2.2 Proposed research infrastructures (RIs) for the period 2017 to 2020In order to trust the results of clinical research projects, each phase of performance needs specific considerations (and specific services). Furthermore, each individual project has its own specialities. Expertise as well as experience is needed to anticipate them and to plan accordingly.

Chart 3: different phases of clinical research1.

During the concept and development phase, the main focus is on scientific, methodological and regulatory issues to be resolved. The rationale for performing the trial as well as the internal (and future external) validity of the result should be in the centre of attention.

Once the study has started, key aspects move to other activities (and again to related services) such as quality control, making sure that the quality of the raw data collected is adequate, the required number of patients is recruited and the reporting obligations are met.

Currently, quality issues and other bottlenecks can be found in all phases of academic clinical research. This is mainly due to missing know-how, time and financial resources.

Services provided by the RIs described below cover all phases of clinical research.

1 Source: Guidelines for Good Operational Practice (GGOP V2) of the Swiss CTU network



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Overview of the proposed RIs and their estimated budget and headcount:

2.2.1 National Safety Office

A National Safety Office provides services centrally to all sponsor-investigators planning and conducting investigator-initiated trials (IITs) throughout Switzerland. The expertise of safety staff increases the patients’ safety as well as the quality of the protocols and data. Sponsor-investigators may focus on the clinical aspects while the safety office allows them to comply with their obligations and duties regarding pharmaco- and/or materiovigilance. The industry benefits by finding a research environment within academia that is familiar with the requirements as set for registration studies.

As the oncology has a broad experience (SAKK CC evaluates yearly roughly 400-500 SAE on running trials) the SAKK CC shall take the full responsibility for academic trials within in the National Safety Office (excluding in vivo drug-drug interaction studies and genotypes/phenotypes). To build on existing competence the National Safety Office should be located at the SAKK CC in Bern.

Lead: SAKK CC (see application by SAKK)

In vivo drug-drug interaction studies and genotypes/phenotypes (personalised medicine) Clinical pharmacology services Drug-drug interaction assessment service, as required by the authorities2 Coordination of clinical studies performing drug-drug interaction evaluations in drug development. Coordination of genotype and phenotype assessment for pharmacogenetic studies.

The SCTO considers this topic safety-relevant. The Geneva Clinical Pharmacology Department, linked with the CTU Geneva, provides services on drug-drug interaction for the academic environment. This part of the Safety Office is reflected here with 0.5 FTE staff at the SCTO/network of CTUs.

2 EMA: Guideline on drug interaction. 21 June 2012; FDA. Guidance for Industry. Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labelling Recommendations).



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Investment needed and required personnelCHF 216’000 Required personnel: 0.5 FTE

Not part of this application: CHF 1.78 Mio and 2 FTEs (2017/2018) and 3 FTEs (2019/2020) will be requested with the complementary application of the SAKK.

2.2.2 Quality Management

National QA Office for Standard Operating Procedures (SOPs)

A national QA (Quality Assurance) office for SOPs guarantees standardised and harmonised procedures within Switzerland. This is a major advantage for the conduct of multicentre studies, as same guidance documents apply in all Swiss study sites. It will greatly reduce the administrative workload for clinical researchers, lead to significant quality improvements, and increase the efficiency of clinical research.

BackgroundIn many instances, the different steps for carrying out a clinical study are not known and investigators are unsure according to which standards and guidelines they have to operate. CTUs already do offer their local SOPs to support researchers, however, those SOPs are not always known and accessible to investigators who are not in the catchment area of a CTU. Furthermore, there is no national set of SOPs available yet.

AimIn order to assist investigators throughout Switzerland, the national QA office for SOPs will develop software shared and accessible online. The web-based quality management module (in line with ICH-GCP requirements) provides researchers with standardised processes that can be adapted to study-specific SOPs.

The national QA office for SOPs will:

develop a fully web-based quality management module in line with ICH-GCP requirements define the processes to be implemented, i.e. a set of SOPs applicable and recommended for the

conduct of multicentre studies coordinate the local installation and adaptation of the software provide training and support for researchers coordinate the maintenance and further development of the software

This service will be provided completely web-based.

Investment needed and required personnelCHF 5.9 Mioi.e. CHF 2.3 Mio in 2017, and CHF 1.2 Mio/year in 2018–2020Required personnel: 12 FTEs in 2017, 6 FTEs in 2018–2020

National QA Coordination Office for Audits

The sponsor is responsible for the quality and GCP compliance of his research project(s) and should establish planned and systematic actions (i.e. audits) to ensure that all requested standards are achieved. Especially sponsor-investigators must rely on specialised staff taking over this task. Adequately audited study sites are a prerequisite for state-of-the-art conduct of clinical studies, be it from an academic or an industry perspective.

Needs of academic investigators and academic sponsorsMost institutions act as sponsors for the IITs performed by their investigators and are therefore liable for the quality and GCP compliance of these studies. CTUs should therefore provide the service for independent audits, however, the growing request for GCP auditors can currently not be covered. Furthermore, following the enforcement of the HRA and its ordinances in 2014, we may expect an increased demand for pre-inspection audits as a consequence of an increased inspection activity of Swissmedic. The SCTO and SAKK CC therefore recommend to jointly build up an auditor pool and the respective competence within the CTU network and SAKK CC to optimise resources.



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Service content Planning and performing internal and external audits, both system and project-related in accordance with

legal requirements and the relevant international standards (e.g. ISO 19011:20113 and the EFGCP Revised ENGAGE Guidelines4).

Quality assessments

Pooling of the respective resources for internal and external audits

Continuous training for qualified auditors

Collaboration between CTU and SAKK network

The requirements for competence and evaluation of auditors are described in ISO 19011 (Chapter 7).

Estimated workload 12 to 18 audits in 2017, increasing to max. 25 audits / year in 2020

Daily QMS consultations

Consolidated proposal for the establishment of a national QA Coordination for AuditsThe SCTO and SAKK recommend building up (2017) and expanding (2018) a QA Audit Unit at a local CTU as well as at the SAKK CC. In a next step, the knowledge of professional auditing capacities and competencies is transferred within the CTU network and SAKK CC to one or two more CTUs (2019/2020). In parallel, an auditor pool is established to cover the increased need for internal and external audits (2017-2020).

Investment needed and required personnelCHF 1.75 Mio.2.4 FTE in 2017, 3.4 FTE in 2018-2020 at the CTU network

Cost coverage of 30% through fees for services is foreseen for the year 2020ff. Audits and auditor trainings are subject to fees.

National Monitoring Pool

Monitoring represents an essential part of quality control (QC) which ensures the successful implementation and conduct of a clinical trial. It is the responsibility of the sponsor(-investigator) to ensure that the trial is adequately monitored. Access to monitors and their expertise considerably facilitates this task.

BackgroundAlthough the actual extent of monitoring is neither well-defined in ICH-GCP nor in the Human Research Act (HRA), it is well recognised that quality measures should be included in the conduct of every clinical trial. Consequently, in order to guarantee for high quality standards both in terms of project management and data quality and reliability, monitoring aspects should remain an important focus.

All CTUs already provide monitoring services and monitors locally. The service offer consists of establishing monitoring plans, making initiation, monitoring and close out visits, write monitoring reports, etc. mainly for their local studies.

AimCreating a CTU monitoring pool and assisting sponsors during the conduct of multicentre trials. The service pool will harmonise procedures and establish a synergistic support system for sponsors in order to facilitate clinical trials on a national level. Consequently, high monitoring standards will be guaranteed including a cost-effective management system.

National database to document monitoring findings: An assignment of the national monitoring pool would be to gather national monitoring experience in order to increase the efficiency and facilitate the conduct of future studies. With the establishment of a harmonised monitoring report, findings applicable to a specific topic (e.g. informed consent) can be automatically transferred in a database. Frequency analysis of respective findings would give important indications as to specific deficits. This knowledge could be used to target specialised trainings for CTU monitors, to emphasise on specific topics during site initiation and to make appropriate

3 Guidelines for auditing management systems4 THE ENGAGE AUDITING GUIDELINE. AN OPTIONAL GUIDELINE FOR GCP COMPLIANCE AND QUALITY MANAGEMENT SYSTEMS AUDITING, European Network of GCP Auditors and other GCP Experts, 2005



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adaptations to the GCP training courses. Thus, the intermediate success of these measures could continuously be evaluated.

Investment needed and required personnelCHF 6.6 Mioi.e. about CHF 1.7 Mio/year. The yearly amount will be reduced due to increased income with fees from services.Required personnel: 16 FTEs

2.2.3 Regulatory Affairs (RA) pool

A National RA Pool coordinates RA support for national and international multicentre clinical studies. Dedicated staff will provide expertise to investigators independent of their home institution.

Service contentThe National RA Pool is responsible for multicentre trials, where local institutions do not have the capacity to deal with the investigator’s request. The local RA staff within the CTUs remains responsible for their institutional studies and will also liaise with their local (sponsor-)investigators in case of multicentre trials.

The services offered by the National RA Pool consist of:

compilation and submission of clinical trial applications to lead EC/concerned ECs in Switzerland support foreign principal investigator for submission of EC application compilation and submission of CTAs to Swissmedic and/or FOPH compilation and submission of CTAs to foreign competent authorities (CA) or providing foreign partner

with needed documents for the submission abroad response to queries of ECs and CAs correspondence with ECs and CAs (e.g. reporting of SUSARs, other relevant safety signals, submissions

of study related reports, etc.) processing of study changes during conduct (e.g. amendments, PI changes, update of investigator

brochures, etc.)

For study sites abroad, RA staff may involve the European Clinical Research Infrastructure Network (ECRIN) for smooth processing with foreign ECs and CAs.

In addition, RA staff from all CTUs and SAKK CC will establish a RA platform for networking and exchange of expertise to discuss current developments and to standardise and harmonise the procedures, to organise and take part in educational trainings and meetings related to regulatory aspects within clinical research. This group also becomes a contact point for ECs and Swissmedic for round table discussions of current developments.

Estimated workload Assumed: 100 regulatory submissions processed

Consolidated proposal for the establishment of a National RA PoolWe propose to build a RA Pool with staff from the CTUs. This pool acts as contact point for the investigators. The National RA Pool, i.e. a member of the RA staff within the CTUs, takes over RA activities for the sponsor-investigators for all planned study sites in Switzerland.

Lead: SCTO

Investment needed and required personnelCHF 3.2 Mioi.e. CHF 0.8 Mio/yearRequired personnel: 4 FTEs



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2.2.4 Education

All groups involved in Education I-III activities shall actively contribute to the task force “Zukunft ärztliche Bildung, Nachwuchs für die klinische Forschung der Schweiz” / “Avenir de la formation médicale – Relève pour la recherché clinique en Suisse”, which is planning training programmes for the promotion of young scientists in the field of clinical research (FOPH, SAMS, SERI, SIWF).

EDU I: National Office for GCP Trainings

GCP trainings are mandatory for investigators and study staff to conduct clinical trials. The national office for GCP trainings will survey and harmonise the entire range of GCP training courses throughout Switzerland. In collaboration with involved authorities, GCP trainings will become available to all (young) investigators.

BackgroundTo ensure high quality in clinical research (and to comply with the law), all research staff must have completed an appropriate GCP training.

AimAt this national office for GCP trainings, researchers can choose and register for their appropriate training course. The offering of trainings will be wide-ranging:

basic GCP trainings (e.g. module 1, module 2 resp. courses for sub-/investigators) advanced GCP trainings (e.g. module 3 resp. courses for sponsor-investigators) German, French, Italian and English courses GCP refresher courses GCP courses for different kinds of studies (i.e. medicinal products, medical devices, HFV projects,

courses for specific groups i.e. paediatric studies etc.) e-learning tools courses on informed consent processes courses on specific ethical topics/research ethics

There are currently about 44 basic courses and about 16 advanced courses per year in Switzerland. Assumption was made that in 2017 there will be 50 basic courses and 20 advanced courses per year (70 courses per year in total). That is a total of 120 course days.

Investment needed and required personnelCHF 2.5 Mioi.e. CHF 0.4 Mio in 2017, 0.7 Mio in 2018–2020Required personnel: 2 FTEs in 2017, 4 FTEs in 2018–2020

EDU II: National Office for CAS/DAS/MAS5 programmes

Continuing education (lifelong learning) is part of each professional’s career. A national office for CAS/DAS/MAS programmes will facilitate access to all available training programmes throughout Switzerland and become an important asset for the high quality of clinical research in Switzerland.

BackgroundDifferent professionals with different education background contribute to the conduct and success of clinical research. However, advanced trainings and continuing education is not yet established for this group of professionals.

AimThe major tasks of this office will be to define learning objectives for each type of programme and to create and maintain a website that will present the objectives and content of the various programmes and modules available in Switzerland to potential students. Objectives and contents will be adapted to emerging needs (e.g. the introduction of the Personalized Health Initiative may generate new educational needs in clinical research).

The national office will not derive income from student fees; this will remain with the local institution operating the training programme. However, it is important to realise this programme on a national level and in a modular way. A full programme on the local level would mean expensive parallel infrastructure and a (too) small number of local experts and potential graduates.

5 CAS: Certificate of Advanced Studies / DAS: Diploma of Advanced Studies / MAS: Master of Advanced Studies



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The following programmes might be part of the CAS/DAS/MAS offer:

Career development for non-Medical Doctors (non-MD) on-site study staff

Usually non-MD on-site study staff manages the majority of responsibilities in clinical study planning and conduct at the study site (study nurses, on-site study coordinators/managers, etc.). The knowledge and expertise of this professional group has a major impact on the quality of (academic) clinical research. An education and career pathway, however, is completely missing in this field.

The goal of this project is to define competence levels and corresponding education standards for Swiss on-site study staff. Additionally, a concept and tools to measure the effects of structured training on the performance of on-site study staff need to be developed and implemented.

National MAS in clinical research

Combination of all CAS and DAS to a national MAS in clinical research

CAS in Data Management

Development of a CAS (module of MAS) in data management

CAS in Quality Management

Development of a CAS (module of MAS) in quality management

Investment needed and required personnelCHF 1.6 Mioi.e. CHF 0.4 Mio/yearRequired personnel: 2 FTEs

EDU III: National Office for Postgraduate Trainings

Harmonising the education within the Swiss CTUs by a well-structured postgraduate educational concept. The SCTO and the network of CTUs will get into a leading role to educate all postdocs in clinical research, either from academia or from pharmaceutical industry.

BackgroundPharmaceutical medicine is a medical-scientific discipline that embraces the whole field of the discovery, research and development of drugs, their licensing by the regulatory authorities and the medical care that is necessary with their use and application in practice. Some of the core activities are the proper planning, conduct and analysis of clinical studies, the correct interpretation of their results and the consideration of the benefit-risk ratio and socioeconomic aspects.

AimThe aim of a national office for postgraduate education of young medical doctors and PhDs located in the Swiss CTUs is to harmonise the education within the Swiss CTUs by a well-structured postgraduate educational concept.

This concept shall guide the applicants to their qualification to become FMH specialists (MDs) or SwAPP diploma holders (PhDs). The task force shall elaborate a concept of a so-called “Weiter-bildungsverbund” (CTU training association), exploiting the possibility of rotations of candidates within the CTUs according to their specific strengths and opportunities (e.g. monitoring, biostatistics, pre-clinical research, etc.).

Opening all training offers to pharmaceutical industry

The SCTO could strengthen pharmaceutical medicine in Switzerland by accepting candidates of pharma-ceutical industries in their programmes. Accepting candidates to university postgraduate education programmes i.e. rotations between academia and industry and more could be an interesting tool to increase the number of highly qualified persons in clinical research in Switzerland.

Investment needed and required personnelCHF 0.6 Mioi.e. CHF 0.15 Mio/yearRequired personnel: 1 FTE



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2.2.5 National Pool for Data Management/IT

A national pool for data management is a key service for the professionalisation and harmonisation of data capturing throughout Switzerland.

BackgroundElectronic data capture (EDC) and the corresponding programmes and systems are state of the art for data capturing in clinical research. Investigators need access to this kind of programmes and systems.

AimThe national pool for data management will create a web entrance for data management needs of researchers not situated at a site with a local CTU. Each researcher will receive initial consulting. Triage of projects will be channelled to local CTUs according to experience and availability. EDC will be implemented within a data management tool (setup, maintenance and closure).

The pool will facilitate networking between data managers of local CTUs, harmonise selection and maintenance of data management tools in local CTUs and develop data cleaning routines.

New developments within data managements might be part of the offer:

Facilitated data collection with an EDC system (e.g. secuTrial)

Development of an electronic tool that allows local centres to find study database entries directly through identifying patient characteristics, such as name and date of birth, instead of using only anonymous patient-IDs as it is the current practice.

This tool would strongly facilitate the work at the individual sites of multicentre studies during data collection. Since most SCTO members work with secuTrial, such an extension that needs to be locally installed would become a strong part of the future collaboration within the SCTO network and would very likely by quickly adapted as a standard procedure.

Online case report form builder

Creating high quality case report forms for clinical trials is one of the big challenges for many clinical researchers. We would develop a collaborative interactive online form builder, which supports clinical researchers in building high quality case report forms ensuring best practices for report design and data collection.

Investment needed and required personnelCHF 8.6 Mioi.e. CHF 2.3 Mio in 2017, followed by 2.1 Mio/year in 2018–2020 Required personnel: 15 FTEs

2.2.6 National Pool for Biostatistics and Methodology

The National Pool for Biostatistics and Methodology provides a nationwide infrastructure open to all academic clinical researchers to support investigators in designing, analysing, and publishing patient-oriented clinical research projects (clinical trials). Such services may improve the quality of the study protocols and in consequence the study results and their validity.

Needs of academic investigators and academic sponsorsStatistical analysis of clinical research projects has grown in complexity over the last decades. It is not only statistical research that contributes to this development, but also the more complex clinical studies done nowadays as compared to studies done in the past. Coordination and closer collaboration helps to access available resources regarding conduct of specific research project as well as a platform for knowledge transfer, education and improvement of statisticians. Furthermore, the possibility to discuss a study protocol in an interdisciplinary environment should be fostered to enhance the quality of the clinical trial.

Service contentStatisticians provide the following services:

statistical planning, i.e. discussion and selection of endpoints, specification of design parameters, and sample size calculation

consultation on methodological issues such as trial design, blinding and randomisation interdisciplinary meetings to discuss methodology of a planned study/trial



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education of other statisticians (on specialist topics) and of non-statisticians (on general statistical topics)

coordinating the access to the specific know-how (internet based) writing statistical analysis plans (SAPs) creation of randomisation algorithms or lists if not available supporting data managers with data checking performing interim and final analyses, validating analyses where required writing clinical study reports (CSRs) and support in writing publications

The national pool for biostatistics and methodology provides

basic, low-threshold methodological and bio-statistical service at each CTU and SAKK CC regular exchange between all statisticians and methodologists to foster knowledge transfer and

collaboration between CTUs and SAKK CC pragmatic models and processes (1st step) and infrastructure (2nd step) for randomisation and

blinding especially in the field of medicinal products

Estimated workload The network of CTUs is involved in approximately 300 trials in the concept phase where methodological quality is assessed. SAKK is the first contact for all academic oncology trials which are not SAKK trials, or trials which request similar statistical guidance as in oncology.

Consolidated proposal for the establishment of a National Pool for Biostatistics and MethodologyAn interdisciplinary network for biostatistics and methodology services should work as a low-threshold one-stop shop to best serve the needs of academic investigators/sponsors.

We therefore propose to establish a pool for statistical and methodological consulting with staff from the CTUs and SAKK CC. This pool acts as contact point for the investigators. Furthermore, a regular exchange between statisticians and methodologists shall be established to foster knowledge transfer and collaboration between institutions.

Lead: SCTO

Investment needed and required personnelCHF 1.6 MioRequired personnel: 3.8 FTEs

2.2.7 Project Management Network

The national network for Project Management in Clinical Trials shall provide a nationwide support infrastructure that is open to all medical disciplines and that enables investigators, sponsor-investigators and sponsors to manage the development and conduct of a multicentre clinical trial.

BackgroundThe regulatory framework for clinical trials defines general tasks and responsibilities of the sponsor during clinical study projects. From the operational perspective, several processes need to be prepared, pursued and tracked under the responsibility of the sponsor on different operational levels during the life cycle of a clinical study. The established SCTO guidelines for good operational practice summarise these tasks and roughly assign them to the different phases of a clinical study project (from concept to completion). However, this needs to be aligned along a process of chronological and logical order to ultimately allow sponsors, sponsor-investigators or support organisations like the CTUs, collaborative research groups and others to structure, oversee and guide the complex machinery of the management of a clinical trial towards safe and successful completion.

A project manager supports the investigator with the following tasks:

derive a realistic study budget from a given trial concept for funding purposes, develop a research proposal into a clinical trial project (comprising of the combination of a study

protocol with all further required documents, taking into account regulatory and legal environment, planning financial and personal resources) through a structured process that is comprehensive and follows a chronological and logical order,



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translate and break down a given clinical study protocol and all sponsor’s responsibilities into individual tasks and processes that can be assigned to involved personnel and time points/periods along the time axis of a clinical trial,

plan, track and control all study related financial flows during a study project, comprehensively manage all tasks involved in performing a clinical trial by involving professional

study management personnel available at the CTUs or comparable organisations.

AimEstablishing a national network for project management for the conduct of multicentre trials. For the realisation of the one-stop-shop, a project manager of the national network takes over all activities for the sponsor-investigator to initiate and conduct the study in all planned study sites, be it in Switzerland or abroad. For study sites outside Switzerland it may be considered to involve ECRIN.

Investment needed and required personnelCHF 9.9 Mioi.e. about CHF 2.5 Mio/year. The yearly amount will be reduced due to increased income with fees from services.Required personnel: 20.5 FTEs

2.2.8 International Network Collaboration Office

Liaise and collaborate with CTU(s) (networks) worldwide to exchange expertise, establish best practices of collaboration and bringing more clinical research projects to Switzerland as a result of a personal relationship and mutual trust between institutions.

BackgroundThanks to the recent development and funding of the Swiss CTUs under the umbrella of the SCTO, the Swiss CTUs are now in the position to actively approach similar infrastructures and networks internationally. Such an extended networking is also very attractive for the Swiss based pharmaceutical industry. Compliance with highest standards in academic research is not only recognised by the international researcher’s community but also by (inter)national scientific grant providers, grant providing foundations and partners/headquarters in the pharmaceutical industry. A close collaboration with academic research abroad is already established via ECRIN, but is limited to Europe.

AimThe CTUs may either offer their services to other institutions worldwide, or exchange expertise with them and establish best practice for future collaboration. The fostering of relations and connections will lay the foundation for future joint projects under harmonised conditions. In collaboration with task force 2 “QA/SOP”, Switzerland could become a pioneer in collaborating with other countries in the build-up for clinical research infrastructure and education in Good Clinical Practice.

To put this initiative systematically in practice following a pre-defined national strategy, coordination and continuity is needed and therefore a dedicated position required.

Investment needed and required personnelCHF 0.9 Mioi.e. CHF 150’000/year in 2017, CHF 250’000 in 2018 et seqq.Required personnel: 1 FTEs in 2017, 1.8 FTEs in 2018 et seqq.

2.2.9 SCTO Executive Office

As a centralised administrative unit, the SCTO will continue to coordinate the CTU network and supervise the related research infrastructures (RIs). Furthermore, the SCTO is the primary contact and platform for all stakeholders involved in clinical research.

As the beneficiary of the contract with the SERI, the SCTO will have an additional list of duties to cope with. Furthermore, the SCTO continues the current activities and those in collaboration with ECRIN, the European Clinical Research Infrastructure Network, and EUPATI, the European Patients’ Academy on Therapeutic Innovation.

ECRIN(-ERIC) allows European clinical researchers to access the Swiss RIs and vice versa (e.g. in context with Horizon 2020).


http://www.patientsacademy.eu/index.php/en/

http://www.ecrin.org/


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EUPATI aims to facilitate patient involvement in research and development and to collaborate in academic and industry research and with authorities and ethics committees. This is done by developing and providing information and building expert capacity among patients and public.

More know-how and expertise in public relation/communication and legal services will be necessary to complete current and future tasks (see below). To manage the funds distributed and the related reporting system via the SCTO, additional accounting and controlling resources are needed.

The governance structure of the SCTO needs to be adapted in order to maintain and expand the executive power. As an example, the function of the SCTO President should be reimbursed, as his/her tasks may no longer be performed in volunteer work. This increase in professionalism will lead to a sustainable and less person-dependent organisation (see section 1.).

In parallel to the establishment of a service pool with RIs, project funding for clinical research needs to be improved. Clinical researchers should be enabled to perform multicentre trials with adequate funds (allowing them e.g. to pay for the use of a RI). If there is no change in the field of project funding, the future service pool may not be working at full capacity – or in other words: there is no need for a service pool if only very few multicentre clinical research projects are performed. Therefore, the SCTO will support any activities to raise money for clinical research on a (inter)national level.

Communication/PR

Communication of servicesIt is of utmost importance to communicate about the planned service pools/RIs with the entire community of clinical researchers (and their home institutions as far as not members of the SCTO). The structures to be developed must be in line with needs of researchers.

Negotiations with public and private funding agencies should take place in order to make the use of RI in all applications for clinical research projects a standard. This will ensure a better outcome and use of the financial resources on the long term. Earmarked budget items will ensure that the money is used for the intended purpose.

Communication with different stakeholdersSince clinical research directly involves the public and patients (in contrast to basic research where the public is only indirectly concerned as tax payer), they are the most important group of stakeholders to be addressed together with the researchers. The SCTO (in collaboration with partners) should strive for a continuous dialogue and collaboration with this group.

Furthermore, partner organisations (e.g. SAKK etc.) also offering services for clinical researchers should be involved in the national pool of services in order to avoid parallel structures. This type of collaboration also needs communication and organisational provisions.

Communication of important changesAs the platform for patient-oriented clinical research, the SCTO has the duty to inform the clinical research community and other stakeholders about important changes in Switzerland and abroad. In addition, the SCTO should stay in contact with its stakeholders and clients in order to get aware as early as possible if there is a need for a change.

Lobbying/pool of experts

As a general rule, the SCTO should be involved in all decision-making processes concerning the clinical research community and represent their interests. Furthermore, in consultation and legislative processes the SCTO should either give input with its own experts or help to find experts in the field.

Legal

Sponsor-investigators need assistance in their efforts to acquire additional study sites, be it in Switzerland or abroad, in negotiation with (foreign) sponsors, academic or industrial, and with intellectual property issues.

In general, the sponsor-investigators (as well as other investigators) have to comply with the rules of their institutional legal service. However, there is only little harmonisation between different institutions and some institutions miss clinical research specific know-how beyond intellectual property issues. But duly elaborated and signed contracts are essential documents of clinical research projects and often a bottleneck for study start. Contract templates for multicentre trials recognised by all academic institutions performing clinical research will significantly assist sponsor-investigators to comply with current GCP regulations and accelerate



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the time to signature. Furthermore, issues around legal representation if the sponsor comes from abroad need to be resolved.

Therefore, the aim is to establish a national best practice for legal matters relating to clinical research for all researchers and endorsed by all concerned institutions.

The SCTO Executive Office will take the lead for this activity. To incorporate the relevant stakeholder’s views and expectations (e.g. pharmaceutical industry) and the involvement of Unitectra/Unitec is prerequisite for this task.

Investment needed and required personnel for the SCTO overallCHF 5.6 Mioi.e. CHF 1.4/yearRequired personnel: 6 FTEs

2.2.10 Clinical Paediatric Hubs / SwissPedNet

The RI SwissPedNet shall facilitate the so far lacking national research in paediatrics on a countrywide scale, put Swiss paediatrics at par with colleagues in other countries in order to perform internationally competitive clinical research and, at the same time, allow obtaining relevant Swiss data for the implementation of evidence-based medicine for children in Switzerland.

BackgroundResearch in paediatrics and research dedicated to children is fundamental for the progress in medicine, not at last since many diseases and chronic traits first manifest during childhood. Hence, clinical studies in children are needed to advance and improve patient care in paediatrics and adolescent medicine, and to translate findings from rare to common diseases.

The Swiss paediatric hospitals do not yet have properly installed RIs to conduct clinical studies in paediatrics. When the European Paediatric Regulation came into force in 2007, many European networks emerged. They are recognised as a prerequisite for the conduct of paediatric clinical trials.

SwissPedNet is internationally linked as a member of Enpr-EMA, the European network of paediatric research at the European Medicines Agency.

In January 2014, SwissPedNet applied to the call for applications for new research infrastructures of national relevance jointly issued by the SERI and SNSF on 23 October 2013.

AimSwissPedNet is a nation-wide research organization consisting of a central coordination office, a central infrastructure for registries, the paediatric pharmacology and technology centre and clinical paediatric hubs located at the eight largest (university) paediatric hospitals of Switzerland.

Each paediatric hub has age- and development-adequate infrastructures (clinical facilities for children) and is staffed with paediatrics-trained personnel, guaranteeing the quality aspects for research in children.



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While being dedicated to children, paediatric hubs are locally closely linked to Swiss Clinical Trials Organization (SCTO) Clinical Trial Units (CTUs), sharing non-paediatric-specific aspects of clinical research with the corresponding facilities for adults. To allow for resource saving synergies, the central office of the SwissPedNet is located within the SCTO Executive Office.

SwissPedNet will be able to integrate and support most of the existing, disease- or organ-specific research networks and paediatric cohorts in Switzerland and thus to achieve further efficiency and to address the manifold aspects of clinical research. Several interfaces/links with already existing and proposed infrastructure, organizations and projects are already established or ready for cooperation.

The overall objective of this proposal is to further develop, professionalize and fortify the national structures (coordination office, registry centre, centre for paediatric pharmacology and technology) and the existing paediatric hub structures. We apply for salaries for research associates and paediatric study nurses at each hub. These positions are a prerequisite to guarantee good clinical practice (GCP) compliance and assure all quality and safety aspects within clinical paediatric research. In addition, SwissPedNet needs salaries for central functions. This includes salaries for the paediatric registry centre, i.e. a database IT specialist, a post-doc position and administrative staff and staff at the paediatric pharmacology and technology centre, i.e. paediatric modelling specialists, paediatric clinical pharmacologists and project manager. The SwissPedNet coordinator (coordination office) is employed at the SCTO EO, his/her salary is applied for by the SCTO.

Investment needed and required personnelCHF 7.4 (10.1) Mio i.e. CHF 1.85 (2.5) Mio/yearRequired personnel: 18.5 (21.5) FTEs



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2.2.11 Other innovative new approach

In addition, the SCTO strongly recommends an innovative idea for a new service, a new approach beside maintenance, expansion and optimisation of already locally offered clinical research services. The SCTO boards have rated the following innovative infrastructure approach as most important for the future activities of academic clinical research and it is in line with other current developments.

However, it represents a new infrastructure and is therefore neither mentioned in the mandate of the SERI nor are corresponding full matching funds for this infrastructure available. Since it does not yet exist, it is not (yet) a budget item for the concerned institutions.

Investing in this new approach therefore means seed money and should be seen in the context with interrelated initiatives as mentioned below.

IT for facilitated access to Swiss clinical data

The research infrastructure IT for facilitated access to Swiss clinical data involves an organisational IT system which is able to query Swiss hospitals’ informatics systems in order to identify potential patients for the enrolment in Swiss cohorts and to associate data to the cohorts. This system will collect and maintain common definitions to enable the use and share of data from the different hospitals for the enrolment of Swiss patients into cohorts and clinical trials.

BackgroundEach hospital has a pool of patient data accessible (and connectable with other data sources) only within the own hospital IT systems (e.g. for data protection reasons).

AimDeveloping a harmonised framework for technologies and procedures to share electronic medical records data − patient data and other patient-related information − between Swiss hospitals for Swiss national multicentre clinical research. Based on existing tools, elaborating a common understanding of distributed services and creating an IT tool that will enable Swiss national multicentre clinical research:

Querying Swiss hospitals informatics systems to identify potential patients to be enrolled in Swiss cohorts and clinical trials

Querying Swiss hospitals informatics systems and sharing to associate EHR data to existing and future cohorts

Sharing of data coming from Swiss hospitals electronic medical records (including phenotype, genetic, laboratory, radiological data)

In order to avoid parallel infrastructures and investments, this task force will be closely interacting with other initiatives that have been submitted, or are under construction or actively contributing, and which will also depend on strong IT infrastructure, such as the Personalized Health Initiative, biobank projects on an institutional/national level, including Swiss Biobanking Platform, Swiss National Bioresource (submitted to SERI on 23 January 2014) and Project EHR 4 CR Christian Lovis (this project has defined tools that could be used).

Investment needed and required personnelCHF 8.2 Mioi.e. CHF 2.05 Mio/yearRequired personnel: 6 FTEs in 2017, increasing to 9.5 FTEs in 2018 et seqq.



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3. Financial plan for the period 2017 to 2020

3.1 Overview of necessary expenditures, financial situation and the requested federal fundsThe financial plan shows an estimate of resources needed to establish or extend individual research infrastructures in order to fulfil the requirement of performing multicentre studies within the network of CTUs. The amounts allocated to the individual work packages may still change once the processes are fine-tuned.

3.1.1 Budget for the proposed new research infrastructures of the SCTO/CTU network

Details about the components that lead to the final budget of each proposed research infrastructure, e.g. costs for personnel, overhead costs, etc., can be found in the SCTO Report submitted on 30-Nov-2014 (see appendix 2). It shows the staggering of each budget line over time and the detailed budget for the SCTO Executive Office.

For RIs generating income with fees for services, a potential income of about 10% has already been deducted from the individual amounts.

3.1.2 Budget for the proposed new research infrastructure SwissPedNet

Budget von SwissPedPha ergänzen!

3.1.3 Budget for innovative approaches

3.1.4 Grand Total



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3.2 Financial contributions by cantons, public institutions, academia and private foundations

The confirmed in-kind contributions are provided in appendix 6.

3.3 Distribution of funds

3.3.1 Distribution key within the SCTO/CTU network

The Steering Board suggests the following distribution key for the federal funds:

60% flat rate for structural funding to each CTU

40% will be distributed by tasks, respectively Work Packages (WP).

The SB will decide about WP distribution based on competitive applications from the CTUs (and other institutions as appropriate). Distribution of the remaining funds will than be carried out in accordance with the CTU/institutions concerned and the SERI.

The rate for structural funding refers to the Masterplan biomedical research (see also 4.1.), where it is stated, that the government must assure basic structures to facilitate clinical research. A basic funding of the existing structures will secure the so far established services and will allow to add-on the WPs.

3.3.2 Distribution key within SwissPedNet

The SwissPedNet Board foresees funding of each paediatric hub according to the size of each (university) children hospital and the research activity expected. A strategy meeting of the SwissPedNet Board on 20.8.2015 will discuss a distribution key and present its result at the General Assembly on 20.11.2015.

The form “FINANZPLAN für die Mehrjahresplanung 2017-2020” as provided by the SERI is enclosed (see appendix 8)



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4. Contribution to the Swiss research and innovation system

4.1 What are the national meaning and the additional benefit from a national perspective?Switzerland faces a decline in the number of clinical research projects being performed. However, different stakeholders are not mainly concerned about quantitative aspects, but rather about quality issues. scienceindustries, as an important example, has issued a position paper in which they define their expectations for improvement with the help of the SCTO (see position paper scienceindustries, appendix 7.). The Swiss Federation, respectively the Federal Office of Public Health (FOPH), has summarised the different challenges and potential solutions in a master plan with the overarching goal to boost Switzerland as a biomedical research and technology centre (see Masterplan). This master plan also emphasises the importance of adequate infrastructure for clinical research as well as trained clinical research staff. The SCTO is mentioned as an important partner to achieve these objectives and to facilitate the performance of multicentre trials.

In the same context, the OECD (Organisation for Economic Co-operation and Development) issued an important report on “Facilitating International Cooperation in Non-Commercial Clinical Trials” with a gap analysis. (see OECD for more details).

The OECD identified three main challenges to be addressed:

The excessive administrative complexity of clinical-trial processes; The desirability of introducing a risk-based approach to the management of clinical trials; The need to improve the education and training support as well as the infrastructure framework in

clinical research, and the involvement of patients.

In Switzerland, the first and second points are partly addressed in the Swiss Human Research Act. In 2008 the Swiss National Science Foundation SNSF (in collaboration with the Swiss Academy of Medical Sciences SAMS) issued a call for clinical research infrastructure in order to improve the infrastructure support.

In the initial phase, the selected Clinical Trial Units (CTUs) at the university hospitals and the Cantonal Hospital St. Gallen primarily had to overcome scepticism and lack of understanding on the local level (as in Europe and other places in the world, this type of infrastructure was new for the clinical research community outside oncology). They established themselves in a relatively short time and meanwhile became a valuable partner for clinical researchers and their personnel. However, their capacity is limited due to missing human and financial resources.

To ensure the national networking and harmonisation, the SCTO as an umbrella organisation was founded in 2009. The SCTO is involved in numerous consultations/working groups substantially influencing clinical research (with the aim to reduce administrative burden without violating the legal framework). The SCTO represents the network and aims to give clinical researchers a voice. Furthermore, the SCTO strongly supports patient empowerment for clinical research in Switzerland.

The CTUs do not only provide a wide range of services, but as another focal point they are an essential partner for education and training for those collaborating in clinical research projects. The SCTO is involved in the FOPHs joint task force with the SAMS on “Nachwuchs für die Klinische Forschung in der Schweiz” / “Relève pour la recherche clinique” and will continuously expand its role in training and education.

In 2012, the SNSF granted a position for a coordinator of a network for clinical researchers in paediatrics, the SwissPedNet. While this allowed to start complementing the “adult CTUs” for children, the need for local hubs is still unmet. SwissPedNet is part of the SCTO and network of CTUs and the application for funding the clinical pediatric hubs is added in this application (see section 2.1.12).

In view of the foregoing, the impact of SCTO and the CTU network activities could considerably increase with an infrastructure of adequate size and financing.

Research Infrastructure for PaediatricsIn the past children were protected from research. The current consensus is that children need to be protected from illness and poorly designed medicines through participation in research. This consensus has driven legislative and regulatory frameworks globally. The most important gap is infrastructure at the site level that allows state of the art performance of clinical studies. Clinical paediatric hubs need to be funded to employ dedicated research staff who can move between multiple research studies. The need for children to have equitable access to research about innovative medicines will increase with the growing impact of advanced technologies and stratified / personalized medicines. This RI will support the delivery of clinical trials involving children to uniform standards throughout Switzerland.


http://www.oecd.org/sti/sci-tech/49344626.pdf

http://www.bag.admin.ch/themen/medizin/14583/index.html?lang=en


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4.2 In what way does this proposal complete tasks that are not accomplished by universities or other already federally funded institutions?

The vision is a “one stop shop” offering services for sponsor-investigators (and other clients) allover Switzerland. So far, the SNSF seed money supported building-up the CTUs in their respective home institutions. Since than, CTUs are solely financed locally. Therefore local research activities are prioritized due to limited resources. To offer coordination offices / service pools on a national level open for all researchers in all disciplines, pathologies and populations, an overriding national funding strategy is required. This will allow the clinical research community to perform multicentre studies throughout Switzerland and also with study sites abroad. There is currently no comparable national infrastructure available besides of the pathology-specific coordinating centre of SAKK.

As already mentioned: in parallel, project funding for academic clinical research has to increase to render multicentre trials possible.

SwissPedNet unifies the efforts of the individual university children hospitals and hence, the endeavours of each medical faculty. No single hospital or even country has enough sick children or enthusiastic investigators to complete paediatric investigation plans, particularly in rare diseases. Paediatric research (and drug development) is inherently multinational. Within paediatric research there is a strong need for networking and (inter)national collaboration. So far, with the exception of paediatric oncology, in Switzerland paediatric research is not yet funded federally.

4.3 Reasons for the confederation to support the proposed research infrastructuresBiomedical research and technology is an area of considerable importance for Switzerland's health system and economy. Therefore a Masterplan was written with the aim to boost Switzerland as a biomedical research and technology centre.

This Masterplan also emphasises the importance of adequate infrastructure for clinical research as well as trained clinical research staff. The SCTO and its network is mentioned as an important partner to achieve these objectives and to facilitate the performance of multicentre trials.

The federal funding of the SCTO and the network of CTUs, including the clinical paediatric hubs of SwissPedNet, is the logical consequence of all these efforts.

It is largely recognized that in clinical settings children cannot be addressed with adult instruments. Therefore, a paediatric RI is needed in the sector of medicines research and development. This shortcoming needs to be addressed in the coming funding period, if a nation-wide RI for all pathologies and population will be established.

4.4 Present track record: most important current publications and other achievements SCTO short report 2014 (see appendix 4). Annual reports of the CTUs of the five university hospitals and the cantonal hospital St. Gallen (see

respective webpages). SwissPedNet Annual Report 2014 (appendix 5).

5. Type specific requirements: Non-commercial RIs (scientific services)

5.1 Association or networking with one or more universitiesThe CTUs of the network are part of the university hospitals or directly of the university (Bern), and hence closely linked to the medical faculties of the Swiss universities. The largest cantonal hospital St Gallen, KSSG, is part of the CTU network and collaborating with different Swiss universities on a project level ( SG – to amend as appropriate)

5.2 Access to the RIs and how far will it be used nationally or from abroad by the research community

5.2.1 Open access “one-stop-shop”

The aim of creating a service pool for clinical research infrastructures (RIs) in Switzerland is to offer a “one-stop-shop” to investigators for the performance of multicentre trials:


http://www.bag.admin.ch/themen/medizin/14583/index.html?lang=en


Report 29-Apr-2015

If a Swiss investigator6/collaborative group initiates a clinical multicentre trial, he/she contacts a CTU of his/her choice (or the SCTO Executive Office, e.g. in case of trials coming via ECRIN) for the services needed. The responsible CTU takes the lead for all other CTUs involved. The CTU supports the investigator in contractual, regulatory and operational issues (as per service agreement concluded). The service level and communication lines need to be adapted to the individual projects in a risk-adapted way to be as cost-effective as possible. For the exchange of medical and scientific expertise, the clinical researchers of a project will continue to stay in direct contact, but relieved of the administrative and bureaucratic matters.

The service pool is also open to foreign researchers/sponsors. In such a case, a legal representation is needed in Switzerland and the CTUs will help to establish this representation.

Other potential clients can approach the service pool too. In case of for-profit organisations, the pricing for services will be adapted.

Ideally, all funding bodies would make it mandatory in future to add earmarked budget items for the use of RIs. Institutions too (being liable for all trials performed in their premises*) should make it mandatory to involve RIs (via service pool or any other type of service provider in case of non-federal funding) in order to guarantee a standardised level of quality.

5.2.2 Workflow within the network of CTUs

The charts below show the workflow in a schematic way. The SCTO will establish SOPs to ensure a smooth functioning of the service pool regardless of which CTU is approached as the lead CTU.

6 If an investigator takes the role of a sponsor (= sponsor-investigator), his/her home institution is overall liable for the clinical study.



Report 29-Apr-2015



Report 29-Apr-2015

5.3 Further future fields of activities and potential contributions of the SCTOThe SCTO anticipates different fields of activities beyond the current proposal.

5.3.1 Collaboration with other partners/infrastructures

Example geographical coverage with clinical research services: Ticino is not yet well linked with the rest of Switzerland in terms of infrastructure. Therefore, a partner organisation (or even member of the SCTO) in Ticino is important in the view of the SCTO. We aim to involve them in the service pool as soon as possible.

5.3.2 Other relevant infrastructures for clinical research

The current initiatives in biobanking and personalised medicine/health are exciting and visionary approaches to future medicine. To implement such initiatives respecting the legal, ethical and scientific framework, appropriate infrastructure is essential.

For data protection reasons, many of the tasks will have to be performed locally and CTUs (with their expertise) would certainly be a highly qualified partner for these activities.

Regulatory processes in Switzerland are still a heavy administrative burden for clinical researchers. However, swissethics, the umbrella organisation of ethics committees, operates in a “Milizsystem” without any professional infrastructure like a back office. As a consequence of these very limited resources, changes in processes need (too much) time and the results sometimes miss professionalism. The SCTO could support swissethics provided that we would have the resources to do so (administration and project management capacity).

The Swiss requirements for Good Manufacturing Practice (GMP) in clinical research are described in the following document: Eudralex Volume 4: The Rules Governing Medicinal Products in the European Union,EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human andVeterinary Use, Annex 13 Investigational Medicinal Products.

The violation of GMP principles (like e.g. inaccurate randomisation of a study drug) are very likely to put patients and data quality at risk. However, the production of GMP-conform study drugs is very demanding and costly. At the same time, blinding and randomisation are very important methodological measures to avoid bias in clinical research. Therefore, the provision of a professional and at the same time lean and cost-efficient GMP service for clinical research purposes could remarkably increase the quality of clinical research outcome. Given that the corresponding resources are available, the SCTO could negotiate and coordinate such activities for academic clinical research projects in Switzerland.

6. Appendices1. Summary of changes to the report submitted on 27.11.2014 and this application2. Report submitted by SCTO/SwissPedNet on 27.11.20143. SCTO bylaws4. SCTO Short Report 20145. SwissPedNet Annual Report 20146. Confirmed in-kind contributions of each institution7. Position paper scienceindustries8. Finanzplan für die Mehrjahresplanung 2017-2020


http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

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