Euro Forum for GCP Issues Report on Indemnity Schemes
The European Forum for GCP (EFGCP) has published its final report, ?Indemnity Schemes for Clinical Trials: A Societal Obligation??
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.
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
May 2nd 2025Interim results from the Phase III ESSENCE trial published in The New England Journal of Medicine show once-weekly semaglutide improved liver histology, metabolic markers, and weight loss in patients with biopsy-confirmed metabolic dysfunction–associated steatohepatitis and stage 2 or 3 fibrosis.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
