EFGCP Broadens Support for Investigator-initiated Trials

The complex legal, regulatory, financial and organizational requirements are not widely known in the investigator, hospital and university communities engaged in clinical research, according the European Forum for GCP. To address the issue, it is running a two-day workshop, called Striving for Professionalism in Investigator-initiated trials (IITs), to be held in Brussels, Belgium, on February 26-27.

The legal conditions for academic sponsorship vary from country to country, which makes the organization of multinational trials even more difficult, noted a statement from EFGCP. 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 for 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 organizers wrote.