Minutes / ENGOT Strategy review meeting October 8, 2016 · PDF fileevaluate goals that were...

ENGOT Strategy review meeting – October 8, 2016

Minutes / ENGOT Strategy review meeting October 8, 2016

Crowne Plaza Copenhagen Towers Hotel, Copenhagen

Attendees: Sandro Pignata (Chair), Christian Marth, Regina Berger, Federico Nepote, Nicoletta Colombo, Andreas du Bois, Antonio González Martin, Eric Pujade-Lauraine, Mansoor Raza Mirza, Jalid Sehouli, Ignace Vergote, Christian Schauer, Anneke Westermann, Andres Poveda, Nelleke Ottevanger Renata Brandtnerova and Zuzana Seps (ENGOT Office)

1. Welcome and opening Prof Pignata welcomed all attendees to the meeting that was called to review outcomes of ENGOT work since 2013 when the first ENGOT Strategic meeting was held. The aim of this meeting is to evaluate goals that were set in 2013 and new goals (if any) should be identified.

2. Introduction In the introduction, a brief overview of the history of ENGOT, mission & vision and values were recalled. Since 2007 when ENGOT was established, 41 trials has been established, 11 scientific publications published, there is 20 cooperative groups within the network and focused networks of young senior trialists (GCA), Phase 1-2 networks and mentoring network for group administrators has been functioning. Within the preparatory work for this meeting, a questionnaire was sent out to all groups while 17 forms came back giving opinions of groups. Summary of questionnaire

Significant changes

• More trials conducted by pharma • GOG and NRG strong competitors • Germany, France, UK increasing influence (rotation) • Biomarkers and profiling • Less purely academic trial

Threats • Pharma and CRO vs ENGOT • Cohesion • Funding of ENGOT trials • Differences in study groups funding • GOG and NRG trials

Opportunities • More translational research • Extending in eastern Europe • Finding an agreement with NRG and GOG (new type of ENGOT trial?) • New field (PROM, low intervention trials, observational) • ENGOT is a fast accruing organization (can be improved with less active groups) • EC funding


Unique role of ENGOT

• ENGOT is leader in phase 3 in Europe • Defend academic independence (although Pharma maintain their strong position) • Over time much stronger and capable of working together • Rules

Domains where ENGOT should be more active

• Alternative funding to pharma (EU…) • Translational projects • Rare tumours • Megadatabase • Mentoring and participation of small groups • Public relations

Things to be improved

• Small and less active groups (mandatory involvement? retrospective or observational trials?)

• The process of how an ENGOT trial is determined (better understanding of rules) • Global collaboration out of Europe. More flexibility in the rules? • Contracts with pharma (standard costs? protection of ENGOT role?)

Goals identified as priority in 2013, results from the questionnaire: Evaluation 1 (not satisfied) -4 (fully satisfied) - Incorporation of Phase I-II trials – 2,3 (partly satisfied) - Incorporation of translational activity – 2 (partly satisfied) - Harmonise operational aspects of trials/quality – 3,2 (satisfied) - Provide teaching and mentoring (GCA and e learning) – 3,2 (satisfied)

3. Evaluation of goals set in 2013 Each goal set up in 2013 was discussed: what was achieve, what was not achieved, what are the obstacles while the outcomes were presented by the leaders. At the end of each section, it was voted on continuing of the tasks and leaders (re) appointed. 3.1. Incorporation of Phase I-II and TR into trials 3.1.1. Phase I-II – Ignace Vergote Prof Vergote summarized achievements and difficulties of the task. Group of enthusiastic young investigators was created and is led by two younger network leaders (Nicole Concin and Ros Glasspool). There were 4 meetings while 2x 4 trials were developed however and unfortunately have not attracted companies for the moment. The network formulated its mission and objectives. Objectives: - To develop network of early phase trial centres and investigators within ENGOT to deliver early

phase clinical trials with strong scientific rational. - To develop novel trial designs that allow efficient assessment of new compounds and make it

feasible to also investigate rare histological and molecular subtypes. - To offer pharmaceutical companies a read-to-go, efficient structure and academic expertise for

accelerated clinical development of their compounds in their pipeline. - To deliver the most promising new compounds and therapeutic approaches to women with

gynaecological cancer.


Achievements: - Establishing of group of investigators with interest in Phase I-II itself and their active

communication. - Development of umbrella trials.

The network itself see its goals in communication with pharma companies, establishing communication with TR group, development of a set of standards for centre selection and processes and to mentor young investigators. Support of the companies seems to be the biggest challenge while a support from other ENGOT members and senior leaders was requested. Outcomes of discussion: - It was noted that the Phase 1 at the beginning moved to Phase 2 which might create a conflict - It is important to have access to drugs, clear definition how to set up the trials, to better identify

a process (limited number of centres, loyal to ENGOT), offer different centres (a kind of rotating) with choice of limited number of countries (10), elite centres, limited pool of centres for small protocols.

- Promote the strengths of the network: structure, quick enrolment, effective and harmonised conduct.

- Create and promote packages: guaranteed numbers within fix deadlines (honoraria decrease if deadlines missed), guarantee quality (bureaucracy), choice of 10 countries, fixed calculation. The structure should be prepared to be very fast and easy to start Phase I. Structure needs to be built, new documents created and companies approached. Also a strict contract bidding is necessary.

- Basket trials can run besides within ENGOT with 20-30 centres. Summary: It was agreed that the goal continues with mixed approaches. Number of centres will be re-assessed, guaranteed quality packages for companies should be created and structure established. In order to harmonize the structure and processes, a dedicated admin person should join the leadership. Cristiana Sessa was suggested as a third co-Chair together with Ignace Vergote and Antonio Casado who are willing to continue to lead. 3.1.2. TR activities – Jalid Sahouli Four meetings have been organized with the goal to create the network, share experiences and brainstorm for study proposals. It is important to learn what each centre can really do, to know the infrastructure in Europe: a questionnaire will circulate about resources and structures within the study groups and phase I centres. Strong bridging concept is required between phase I/II group and TR group. Different proposals have been developed for tumour banking. Maintenance and money are the main problems. Actions to increase the TR in ENGOT trials will be further discussed during the brainstorming (see point 5.4.) Summary: Activity should continue. Financial plan must be discussed and a headquarter can be delegated.

3.2. Harmonize operational aspects of trials/quality – Regina Berger

Steps set in 2013 Actions taken


1. To define / update the parameters to select the sites in each country/group

Minimal requirements for site selection guideline established 2015

2. Re-evaluation of the operational structure of each group

Group structure survey 2013

3. To share work packages -> e-CRF or statistics, or pharmacovigilance, catalogue etc.

Resource sharing survey 2014

4. Regular update about new EU regulations

Regular EU regulation updates through Anastassia Negrouk (EORTC)

All proposed steps have been completed, however to date no resource has been shared and the groups structure survey has not been utilized. Obstacles: - Groups feedback and activity. - Important variation in group structure. - Not every group has a dedicated administrative person, personal changes of operational people. - EU Regulation delegate’s infrequent attendance. Summary: Goal continues especially in regards to utilization of information collected and steps regarding preparedness for EU regulation 536/2014. Documents are available at ENGOT Office and will be published on the website. It was suggested to replace Anastassia Negrouk (EORTC) while the person responsible for update about EU regulations should attend ENGOT admin meetings. Regina Berger as ENGOT Admin co-Chair will lead the activity (leadership changes every 2 year).

3.3. Provide teaching and mentoring 3.3.1. Gynaecological Cancer Academy (GCA) – Nicoletta Colombo The goal of GCA was to create a network of young senior investigators, neuter their strategic partnership and transfer the knowledge of conducting of clinical trials to the new generation of young investigators. Two series of GCA cycle (four workshop in 2 years) successfully run with a very positive feedback from attendees. Venue of workshops was rotating in ENGOT group countries. Presentations were recorded and available on the website which is good from educational point of view. The goal was achieved, it is worthwhile to continue while the funding is the main issue. During the discussion that continued the financial, organisational and scientific aspects were discussed. It was mentioned that there is no financial reserve for 2017, meetings of other networks are requested and the current model is not financially sustainable. Different suggestions to reduce costs were questioned (contribution of groups to cover flights, cheaper venues, off season, less speakers, use of local speakers, honoraria etc.). Outcomes: - Scientifically GCA needs to be kept at the same level including the number of speakers involved. - Coverage of flight tickets may not be feasible for lots of groups, travel expenses must continue to

be paid. - Meetings do not need to rotate while the more expensive countries should be avoided. Cheaper

locations/venues should be searched. - Socialising is an important aspect and should be kept as a part of the concept. Therefore GCA

meetings should not be held at airport venues.


- It was agreed that in order to reduce costs, honoraria will not be paid. - Groups should wiser nominate the attendees who should be the young investigators with

capacities of becoming future leaders. It was felt that attendees to the 2nd series were less experienced. It might have been caused by the fact that it was requested to nominate different people to the three networks (GCA – Ph1-2 – TR). It was agreed that overlapping of names is natural and may increase quality of discussions. Therefore it was agreed that meetings of networks should not run in parallel during the GCA.

- GCA Workshop can be linked with ENGOT meeting. Andreas du Bois suggested to explore opportunities within the European Cooperation of Science and Technology (COST) EU program (see presentation circulated prior the meeting). COST is an intergovernmental organisation supporting the collaboration of nationally funded science and technology research through the creation of networks (COST actions). This is not program for funding of research but networking tools such as meetings, workshops, conferences, training schools, short term scientific missions and dissemination of activities. It would worth to hire consultant to explore these opportunities (will require extra admin support paid by ENGOT). Summary: The GCA is a very successful project and will continue within the similar high quality scientific level concept. There will be 3 workshops in next two years (fall 2017 - spring 2018 – fall 2018). Meetings of networks (GCA, Ph1-2, TR) will be separate while the GCA workshops will be kept at non-airport venues. Focus will be on fund raising & more sponsors should be involved (Roche, Astra Zeneca, Tessaro, Pfizer). Full organisational concept and budget should be prepared. The COST program should be explored. Christian Marth was appointed to lead the 3rd GCA series 2017-2018. 3.3.2. Teaching and mentoring of admins – Regina Berger Achievements: - Welcome package for new representatives, mentors. - Some groups visited and trained on site. - Group is still working on budgeting a trial. Obstacles: - Many new admins, not enough mentors. The goal continues, welcome packages for new admins are currently under the review. The ENGOT Admin co-Chair (currently Regina Berger) takes the lead. 3.3.3. eLearning – Christian Marth Achievements: - ENGOT eTutoring at the ESGO eLearning Platform. - Power point presentations prepared by groups on featured topics. - Regular webcasting of frontal presentations of GCA workshops. - Not all topic areas were covered, no visibility at ENGOT website.

Obstacles: - Lack of time of volunteers. As an outcome of discussion, it was felt that this is not a task for a study group network, it is an ESGO activity while the ENGOT should rather concentrate its effort on study activities. It was agreed not to continue with this activity.


4. Status of ENGOT collaboration Prof Pignata summarised the history of ENGOT founded in 2007, since then, there are 20 groups from 17 countries involved and 41 trails in 9 years have been performed. List of groups and their involvement in trials was presented:

13/19 leading at least one project, only 9 groups participated to more than 10/41 trials. There is a need for a wider involvement of the less active groups. This list of collaborated groups should be updated for every ENGOT meeting (incl. number of recruited patients). In general, there is not enough participation of groups in trials which should improve.


There is a trend of decreasing B and C trial while the A trial are increasing. This has a direct impact on

the financial model of ENGOT (need of more C trials). Type A include 2 different types: purely

academic without pharma support and fully supported trials. Only 6 groups leading a type C (more

rotation?) while there were few trials in endometrial (3), cervix (2), rare cancers (2). ENGOT lose C

trials (impact on financial model of ENGOT) and face competition of CRO.

5. Discussion and brainstorming 5.1. How to improve the collaboration with less active groups (barriers, type of trials, rotation,

mentoring) The discussion was open by stating that there should be a special mentoring program for all the groups with less than 5 collaborations and all new groups. The barriers should be analysed. There should be more retrospective and observational studies that are easier for smaller groups to take the leadership. There should be a mandatory participation of at least 1 group in new trials. Discussion: - There are different reasons why groups do not collaborate or lead a trial. - Some groups are not in condition to lead a trial, the structure of groups within ENGOT is very

different. - First should be participation followed by leadership. - Efforts to bring study groups for leadership. 2 or 3 groups could have done all the studies. Groups

put lots of efforts and energy to convince pharma that they should collaborate with smaller groups. Obviously position of some groups is stronger, the rotation is not always possible.

- Model A is coming from the group and it is not possible to rotate it, only model C can be rotated, rotating is not a major issue.

- Mentoring is important. Big groups gave a lot of support. - Create simple trials and initiatives where smaller group can participate. - Small groups should analyse their problems, find the barriers, say what kind of mentoring they

need (not to do it the other way round). Small groups should be active, ask the bigger groups what they want.

- Participation in the projects is mandatory, otherwise there is no reason to be in ENGOT.


- Small groups have funding problems: to pay the admins, organizational people, the start is very difficult. However, they have responsibilities to grow up, build the structure and participate in projects.

- Training model should be developed for the new members, onsite visit of clinician and admin at the mentor’s place is the best. Mandatory part to the mentoring should be explanation of history, rules etc.

Summary: Less active groups should analyse themselves their barriers and needs. Mentor and new group should decide on the format of mentoring, ideally clinician/admin should spend 2 days in the training centre (should be included in the confirmation letter). Mentoring on rules should be mandatory part of the visit. Beginning and refreshing package for non-active groups will be prepared. Leadership should follow participation. Retrospective and Action point: Prof Pignata to formally approach the less active groups to identify barriers. Training model of the new group (PGOG) and mentorship should be established. 5.2. How to improve the portfolio in rare diseases - Create a working group with a goal of 3-4 studies in 2 years. - More retrospective data. - GCA dedicated to this topic. - Rare tumours are also included in objectives of the Ph1-2 network. - Lousy trials, often closed, difficult topic, include rare tumours into biology driven trials. - Collect information about currently running projects, ask groups to provide this information. - European EUROCAN project (Michael Soeckl) – how many centres are involved? - Work together with the GCIG? No, working group should be inside ENGOT. - Identify young investigators from groups who can take care of this activity in more active way. - Creation of database as on observation registry. Which group have possibilities and resources to

host such database? - Check if there are calls under H2020. Summary: It was agreed that rare tumours is not a specific goal. Action point: Prof Pignata/ENGOT Office: Groups to be approached to collect the running activities and identify younger investigators interested in rare tumours. It should be explored which group has possibility to host the database. 5.3. Competition with CRO and GOG/NRG Does ENGOT need more flexibility or more rigidity according to ENGOT rules? There were 2 possible actions for discussion:

• 1 new model with less control on database ad copartnership with NRG/GOG or others allowed, alternating the main Chair.

• Cohesion among groups in refusing the trial not conducted in ENGOT. Discussion: - A fear has been expressed that ENGOT lose important trial run either by pharma or GOG if

strictly stick to the rules, however, even within the rules, it is stated that exceptional cases may exist – which could be used in critical cases.


- Issue with Pfizer: Database sharing and analysing is possible however the company can get access to the database only at the end, not during the trial. ENGOT has to be strong.

- Issue with Roche: Trial lead by GOG & recruiting patients at centres in Europe. Many ENGOT groups decided not to participate under these circumstances, however, some ENGOT groups feel not able to block the centres if they are approached by the company directly.

- In special situations, ENGOT can join a trial that is led by a GOG person who could be confirmed by ENGOT retrospectively. Nevertheless, ENGOT should be strict in other issues related to reliability of ENGOT trials (academic evaluation and discussion of the protocol, independent academic analysis of main endpoints, involvement of ENGOT groups, site selection by the ENGOT groups, handover of the database at the end of the trial for further scientific use). The FLOC Roche trial is an example and it has been decided to proceed if Roche accepts these prerequisites.

- GOG can run a trial, the main point is the database, independent analysis, academic evaluation, communication, …

- The most important thing is, that there is an independent academic statistical analysis of the

main endpoints before data are presented and published. Therefore, the handover of data and

the independent analysis has to be organized publication/presentation. (in this special case:

GOG may serve and perform the independent analysis – if they are not willing to do so, MITO as

ENGOT facilitator should organize it)

- Furthermore, each study group should receive their own data after the trial has been finished.

- There should not be co-leadership. There must be 1 leader with possible alternation. We should avoid co-chairs blocking all.

- Official agreement on both the above mentioned rules and for publication and presentation must

be signed upfront, it must follow ENGOT rules (ENGOT number should appear on all publications,

cohesion, ENGOT has to decide for all ENGOT groups, sharing database, etc.), and authorship

rules of ENGOT.

Summary: It was agreed that in exceptional cases, rules can be partially revised and ENGOT trial can be led by non-ENGOT group (GOG). In respect of authorship, the first place can be shared, other places according to recruitments as defined in ENGOT rules. Alternation of leadership in case of future exceptional trials should be agreed upfront. All other ENGOT requirements should be met (selection of centres, database, analysis) and cohesion respected. Prof Pignata will be the PI for Europe in the Roche trial. Action point: Prof Pignata to contact Roche to stop activities of CRO and contact GOG to install framework for cooperation. Negotiation with Roche about the above mentioned issues and information of the groups if the negotiations had been successful 5.4. Actions to potentiate TR activity - H2020 may be the opportunity how to fund projects. Calls will be distributed to groups (Prof

Pignata) - TR platform is needed to sustain, how to bring TR to Phase I-II trials, create TR tumour banking. - Prof Sehouli proposed that the EUTROC Charite tumour banking becomes the official ENGOT

Tumour bank. It was noted that the structure is flexible, open for everybody (come criteria have to be fulfilled), rules are in place (access to data). If it is accepted, Prof Sehouli will continue to lead the project assisted by his younger colleague Ioana Braicu.

Summary:


There was an offer of Prof Sehouli who proposed that the Tumour bank developed at Charite Berlin becomes the official ENGOT Tumour Bank. Action point: Prof Sehouli will prepare full proposal for the next ENGOT meeting (processes, data sharing…) incl. maintenance and all financial aspects.

6. Finances 6.1. Review of financial model

There are no membership fees to ENGOT.

10% of overhead from educational grants applies.

Contributions from trials:

1) Trials with database B and C

Up to 200 patients up to Eur 5.000 (to be discussed per trial)

201 – 999 patients Eur 10.000

1000+ patients Eur 15.000

2) Trials with database A (academic) - Individual contribution depending on support received leading group should try to plan a contribution

Issue: Contributions are mainly linked with b and c trials whilst their number is decreasing and the contributions from a trials is on volunteering basis. ENGOT covers • ENGOT Assembly costs, 2 @ year (meeting room, flights admins up to 350 Eur, lunch & coffee) • Admin Pre-meeting, 2 @ year (1 overnight & dinner) • Secretariat & Website

Groups cover • Flights of clinicians to ENGOT Assembly • Mentoring groups involve their own resources on support smaller groups Number of trials with db B and C is decreasing (see point 4-Status of collaboration) which has direct impact on the financial stability of ENGOT. Currently to cover the fix expenses (as above), ENGOT needs incomes 50-60.000 Eur, there are financial requirements linked non trial activities. 6.2. Financial contribution of groups


Outcomes of discussion: - The model of coverage should remain unchanged. - Trials with database A that are fully funded should also pay full contributions. - Contributions should be increased to 15.000 Eur (also retrospectively for running trials) - Groups with governmental funding not contributing through trials should pay membership fees

(2.000 – 3,500 Eur) and cover costs of their young investigators to participate to GCA workshops.

Action point: To prepare the new financial model for approval at the next ENGOT meeting (ENGOT Office)

7. Summaries and closing Identified actions and goals


Outcomes from the strategy meeting will be presented at the next ENGOT meetings in March 2017 for validation of the Assembly. The next Strategy retreat will be held in 3-4 years. Every group leading trials will be invited to take part (one from a group). Meeting was adjourned at 4 pm ----------------------------------------- Sandro Pignata, ENGOT Chair Minute taking: Zuzana Seps, Renata Brandtnerova, ENGOT Office

Minutes / ENGOT Strategy review meeting October 8, 2016 · PDF fileevaluate goals that were...

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