Euro Forum for GCP Issues Report on Indemnity Schemes - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
Euro Forum for GCP Issues Report on Indemnity Schemes

Source: Applied Clinical Trials Digital Edition

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.

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
7%
Create entirely its own pathway program?
7%
View Results
Untitled Document
Source: Applied Clinical Trials Digital Edition,
Click here