Joint Scientific Consultations
A Joint Scientific Consultation (JSC) is a procedure during which the developer discusses its trial plans with European HTA experts (and, in some cases, medicines regulators) and receives non-binding advice on study design, patient groups, comparators and outcomes, so that the evidence generated will be useful for future EU HTA activities, including JCA.
A Joint Scientific Consultation (JSC) provides scientific advice to health technology developers on the studies and evidence they plan to generate.
The advice may cover study design, patient population, comparators, outcomes, analyses and health economic considerations, helping ensure that the evidence generated is suitable for a future Joint Clinical Assessment.
A JSC does not evaluate the technology or make recommendations on funding or reimbursement decisions.
Main phases of a JSC
A JSC has two main phases:
- Phase 1
Submission of the briefing package
The developer sets out its evidence generation plan and questions, which are reviewed and consolidated into a List of Issues with input from experts.
- Phase 2
Discussion meeting
The List of Issues is discussed with the developer and the evidence generation plan is refined before the final advice is approved.
Phase 1: Submission of the briefing package
- The health technology developer (HTD) submits a briefing package, describing its evidence generation plan and the questions for which it seeks scientific advice.
- The briefing package is reviewed by the assessor team and the JSC Subgroup, which may request additional clarification or information.
- The HTD addresses these requests and submits an amended briefing package.
- The amended briefing package is shared with the JSC Subgroup and experts, who review the proposal and provide comments.
- The assessor team consolidates this input into a List of Issues, structured around the PICO framework and other aspects of study design.
- The List of Issues is shared with the HTD in preparation for the Discussion Meeting.
Phase 2: Discussion Meeting
- The HTD submits written responses to the List of Issues.
- Assessors prepare a draft JSC outcome document.
- The draft document is shared with the JSC Subgroup for comments.
- A virtual discussion meeting is held between the HTD, the assessor team, members of the JSC Subgroup, experts and, in parallel JSC procedures, representatives from the European Medicines Agency (EMA).
- During the meeting:
- the List of Issues is discussed
- recommendations from the JSC Subgroup are discussed with the HTD
- the proposed evidence generation plan is refined to ensure it is fit for purpose
- Assessors prepare the final JSC outcome document, which is validated by the JSC Subgroup.
- The final JSC advice is approved by the HTA Coordination Group (HTACG) and shared with the HTD.