EFGCP Workshop on Striving for Professionalism in IITs

The value and importance of investigator-initiated trials (IITs) are broadly accepted in healthcare. Treatment optimization, exploration of new indications, head-to-head comparison of new medicines, investigation of long-term treatment outcomes and/or efficiency of treatments are important tasks of the medical community. Like for pharma company-initiated trials the overall responsibility for the trials lies also in IITs with the ‘Sponsor’. But in contrast to privately sponsored studies the infrastructure to fulfil these sponsor obligations is not always available in an academic environment. The complex legal, regulatory, financial and organisational requirements are not reliably known in the investigator-, hospital- and university- community interested and engaged in doing clinical research. In addition, the legal conditions for academic sponsorship vary from country to country which makes the organisation of multinational trials even more difficult.

This workshop aims at bringing together investigators, academic organisations, hospital and university administration representatives, regulators, ethics committee members, lawyers, pharmaceutical companies, SMEs and patient representatives from different countries to learn about different approaches to sponsorship and public-private partnerships in conducting clinical trials in different countries. Focus will be on different sponsor tasks and business models, contracting and training. As a result of these multi-stakeholder discussions it is intended to support professionalism in IITs through working out recommendations for facilitating and harmonizing the framework and organisation for investigator-initiated clinical research.