WORKSHOP. Analysis of the Bottlenecks and Challenges in Designing and Conducting Multicounty Investigator Initiated Clinical Studies (IICs) Pillar 2B

ERA4Health Partnership organised its first face-to-face workshop in Paris on September 14th & 15th, hosted by the European Clinical Research Infrastructure Network (ECRIN). More than 65 participants came together to discuss the challenges in planning and designing IICs. They included representatives from the different institutions of the ERA4Health consortia and other relevant stakeholders, such as sponsors, investigators, EMA/ACT-EU and European Medicine Agencies, ethics committees and methodologists. The European Commission (DG-RTD) representative, Grzegorz Owsianik, and the Project Officer from HaDEA, Monica Ensini, were also in attendance.

The first day kicked off with a presentation on the current status of one of ERA4Health´s deliverables, a report on obstacles and challenges to the planning and conduct of IICs. Through a systematic literature review, this report will describe what has been published so far on the topic, with the main barriers identified relating to funding, personnel training, lack of harmonization in applicable regulation and administrative constraints. The day continued with presentations of different stakeholders’ perspectives, including investigator’s, sponsor’s, funder’s and regulator’s points of view. The session was followed by a lively debate on the difficulties encountered in funding these clinical trials. For the most part, these rely on complex public funding rules and suffer from inadequate timeframes. Regulators highlighted the lack of awareness by the scientific community of the tools developed by regulators to support academia. Funders highlighted the importance of developing a framework to ensure and improve the quality of funded IICs, through appropriate monitoring, and investigators call for improving project evaluation including assessment of the sponsor´s operational capacity.

The second day focused on challenges and opportunities for new trial methodologies: clinical trials with complex design (basket, umbrella and platform trials), trials within cohorts (TWiCs) and decentralized trials. Challenges and opportunities were described through different perspectives (study design, sponsors, regulator and investigator) and audience´s feedback was collected through an interactive session. Main challenges are linked to the lack of experience on implementation of some new methodologies (decentralized trials) while others more widely used (platform trials) still face difficulties linked to the administrative burden of the implementation of the current Clinical Trials Regulation (CTR) and site contracting.

It is expected that the work carried out over these two days will contribute to one of ERA4Health main objectives, establishing a framework to support multinational Investigator Initiated Clinical Studies.