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The complex legal, regulatory, financial, and organizational requirements are not widely known...
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.
The workshop aims to bring together investigators, academic organizations, hospital and university administration representatives, regulators, ethics committee members, lawyers, pharmaceutical companies, and patient representatives. The focus will be on different sponsor tasks and business models, contracting and training, and the aim is to produce recommendations for facilitating and harmonizing the framework and organization for IITs.