The European Forum for GCP (EFGCP) has published its final report, “Indemnity Schemes for Clinical Trials: A Societal Obligation?”.
The document was produced for a workshop held in Brussels, Belgium, last month. It was organized at short notice by the EFGCP, the European Cancer Patient Coalition, the European Federation of Pharmaceutical Industries and Associations, and the European Organization for Research and Treatment of Cancer (EORTC). More than 40 multi-stakeholder delegates from 16 countries met on 5 December at the headquarters of the EORTC to debate the preferred options for a future European patient indemnity system in clinical trials.
The report makes several key recommendations:
• Put patients first
• There should be equality of indemnity coverage for all European study participants
• “No-fault” schemes are preferable
• Indemnity coverage fees must be reduced
• Coverage conditions must be clearly defined and easy for patients to understand
• A guideline is required to provide better and harmonized definitions of “risk in clinical studies”
• Academia needs the implementation of national indemnification mechanisms on a non-profit basis as, for example, exist in Sweden or Denmark.