The second ERA4Health workshop hosted by ECRIN on Funding Mechanisms for Investigator-Initiated Clinical Studies was held on 8-9 February 2024, in Brussels, and brought together funders, clinical study experts, the European Commission, and HaDEA representatives. Its goal was to explore funding for multinational investigator-initiated clinical studies (IICS), addressing public health needs.

The workshop began with introductory remarks from Monica Ensini, Scientific Officer at HaDEA A3 Health Research, and Cristina Nieto, the ERA4Health coordinator from ISCIII. Marta del Álamo from ECRIN highlighted significant challenges and bottlenecks related to funding mechanisms for investigator-initiated clinical studies. The workshop continued with presentations from different initiatives currently funding or planning to fund multinational studies in various topics (infectious diseases, cancer, vaccines, rare diseases, comparative-effectiveness) and setups (European, international). These models and funding strategies introduced on Day 1 set up the base for Day 2, reserved for ERA4Health partners, focused on discussions of possible adaptations of the current Joint Transnational Call funding mechanism to the objectives of the planned ERA4Health Pilot Call on IICS

ERA4Health Partnership is organising its second two-day workshop, “Funding Mechanisms for Investigator-Initiated Clinical Studies,” from February 8th to 9th in Brussels. This event is a golden opportunity for participants engaged in ERA4Health initiatives and invited speakers to delve into the intricacies of organising funding for multinational investigator-initiated clinical studies.

The agenda includes discussions around existing funding mechanisms, transnational funding models, and eligibility criteria and selection procedure for multinational investigator-initiated clinical studies.

This is a closed meeting for ERA4Health participants and invited speakers.

Investigator Initiated Clinical Studies (IICS)

Clinical research involves testing new discoveries by carrying out carefully controlled investigations on patients – known as clinical studies. This includes testing not only new or repurposed medicines, but also comparing various treatment regimens, medical devices, therapies without medicinal, diagnostic procedures, prevention measures, as well as optimizing the use of existing medicinal products and procedures to promote better health and welfare and/or cost saving to the society. Many of these studies and trials are non-commercial, initiated by investigators, usually driven by pressing public health needs and scientific opportunities, which do not offer a strong business case to private companies. This is referred to as investigator-initiated clinical studies (IICS) where the investigator conceives the research and develops the protocol.

 Outcomes of the Workshop

This workshop serves as a dedicated platform for ERA4Health participants and invited speakers to discuss suitable models to support multinational IICS. Day 1 will feature in-depth discussions on various funding mechanisms for multinational investigator-initiated clinical studies, fostering a collaborative environment for knowledge exchange.

Importantly, the outcomes of Day 1 will be publicly summarized in a report, offering insights into the key takeaways and discussions that transpire during the event. However, it’s noteworthy that outcomes from Day 2 will be exclusively reserved for ERA4Health partners, ensuring a confidential space for strategic discussions and planning for the next phase of the Partnership.

This workshop promises a unique blend of expert insights, collaborative discussions, and practical knowledge sharing. Follow our social medias for real time updates & future events organized by the ERA4Health partnership.

Agenda

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.

Official Report 

Virtual 9th June 2023 From 9.00 to 12.00 CET

ERA4Health Partnership is organizing an international workshop to promote collaboration and interactions at a transnational level, towards a European (and beyond) Research Area in Health Research. The main aim of this workshop is to explore synergies between activities in ERA4Health and other relevant networks and to facilitate their alignment with national policies.

More than 50 initiatives at European and international level will be presented by the members of a Synergies Working Group (SWG) set up for this purpose.

Workshop Synergies Agenda Programme