Identifying and recruiting patients for clinical trials in the future: a pharma

perspective

Rob ThwaitesEC/EFPIA Workshop on ”Primary and secondary use of

EHRs: Enhancing clinical research”11 Oct 2007

Identifying and recruiting patients for clinical trials in the future: a pharma perspective

In the near future there are major opportunities for recruitment activities to become increasingly electronically integrated– To date largely paper-based (or electronically separate)– In the future, electronic integration will be key

An example: protocol assessments will be increasingly electronic – Protocol assessments are a major part of trial feasibility questions– A joint process in the future will be built upon shared or integrated

electronic protocol assessments

The new approach to protocol assessments will change the interaction between the different participants:– There will be new roles, responsibilities and sharing of risks– How might other aspects of patient recruitment be affected, and

what will be the impact on existing interactions?

Clinical trial activities today are typically either unconnected electronic activities or still paper-based tasks

Typical overall process for a pharmaceutical company sponsored clinical

trial Initiation and recruitment

Analysis and reporting

Need for specific CT identified in the development plan

Concept protocol written

Possible sites surveyed for estimates of eligible subjects

Analysis plan agreed

Clinical trial protocol, plan and budget finalised

Trial registered

Sites identified

Approvals received

Sites initiated and trained

Subject recruitment programme undertaken

Potential subjects identified; consent requested

GP notified of subject participation

Subjects screened

Subjects entered into trial and allocated code

Subjects follow requirements of protocol

Data collected using CRF

Subjects safety monitored

Monitoring visits conducted

Source data verification conducted

Data (coded) brought in house by sponsor

Study design and planning

Study conduct

Databases “cleaned” then locked by sponsor

Data analysed by sponsor

Final study report written by sponsor

Results disseminated by sponsor and investigators

In the near future there are major opportunities for recruitment activities to become more electronically integrated

Opportunities in recruitment in a pharmaceutical company sponsored

clinical trial Initiation and recruitment

Analysis and reporting

Need for specific CT identified in the development plan

Concept protocol written

Possible sites surveyed for estimates of eligible subjects

Analysis plan agreed

Clinical trial protocol, plan and budget finalised

Trial registered

Sites identified

Approvals received

Sites initiated and trained

Subject recruitment programme undertaken

Potential subjects identified; consent requested

GP notified of subject participation

Subjects screened

Subjects entered into trial and allocated code

Subjects follow requirements of protocol

Data collected using CRF

Subjects safety monitored

Monitoring visits conducted

Source data verification conducted

Data (coded) brought in house by sponsor

Study design and planning

Study conduct

Databases “cleaned” then locked by sponsor

Data analysed by sponsor

Final study report written by sponsor

Results disseminated by sponsor and investigators

Identifying and recruiting patients for clinical trials in the future: a pharma perspective

In the near future there are major opportunities for recruitment activities to become increasingly electronically integrated– To date largely paper-based (or electronically separate)– In the future, electronic integration will be key

An example: protocol assessments will be increasingly electronic – Protocol assessments are a major part of trial feasibility questions– A joint process in the future will be built upon shared or integrated

electronic protocol assessments

The new approach to protocol assessments will change the interaction between the different participants:– There will be new roles, responsibilities and sharing of risks– How might other aspects of patient recruitment be affected, and

what will be the impact on existing interactions?

Where protocol assessments are done currently, there are typically three distinct roles...

Sponsor

Runs initial protocol assessment

Investigator

Designs study

Commissions initial protocol assessment

Selects investigators

etc.

Analyst

Conducts local protocol assessment

Recruits patients

etc.

Where protocol assessments are done currently, there are typically three distinct roles with two sets of interactions

Sponsor Analyst Investigator

Interactions

1. Study design protocol assessment:

Do subjects for the study exist (in principle)?

• Sponsor provides draft eligibility criteria to Analyst

• Analyst conducts protocol assessment on general patient database

2. Study initiation protocol assessment:

Do subjects exist at the proposed investigator site?

• Sponsor provides final protocol to potential investigator

• Investigator conducts survey/analyses charts/guesses number of potential subjects

With widespread availability of EHRs and skills in analysing the data, roles may change...requiring different interactions

Sponsor

Analyst

Investigator

Analyst

NB This is one example of how roles may change: in this case the analyst roles are internalised

A joint process in the future will be based on shared or integrated protocol assessments

Site investigator

Sponsor Clinical

Sponsor Analytics

Site Analytics

Draft Protocol

Execute PA Validate codes Deliver report

Adapt codes Run local PA Deliver report

Advise on local feasibility

Finalise Protocol

Finalise PA, codes and report

Refine PA Deliver report

Develop recruitment proposal

Recruitment proposal accepted?

PA = protocol assessment

In this example, how might interactions change, and what practical steps can we take?

Changing interactions (examples)– Sharing information between sponsor and potential investigator

• Protocol assessment together with the coding and detailed analysis – Lower, and better shared understanding of risks associated with

recruitment– Bringing potential investigators into early design discussions?– Changing need for Analyst role (may be internalised)– Growth in Analyst role – sharing data, analysis and judgement with

sponsor– Resource synergies – analyses can be adapted very quickly

What practical steps can we take? – Commit to sharing protocol assessments (and coding etc) with

potential investigators– Raise awareness of value of protocol assessments within pharma and

other research bodies– Press data vendors to access (and make available) relevant data– Support work of the Filtered Query group under HL7