Clinical Trials Data Sharing in Europe
More Voices Enter Clinical Trials Data Sharing Debate in Europe
09.20.13 | By Mark Grayson
A new paper released this week highlights issues surrounding the discussions on clinical trial data & The paper Clinical Trials and Data Transparency: The Public Interest Case, highlights specific problems to the current draft European Medicines Agency (EMA). Among the problems highlighted were gaps in the protection of patient privacy, further bureaucratization of an already bureaucratic system and conflicting policies on regulatory data protection.
The paper concludes that the release of large amounts of detailed clinical data proposed by the EMA is not a direct, practical solution to the problems that the EMA identifies in the current clinical research environment in Europe. As a follow-up to the paper one of the authors suggested in Pharmaceutical Executive that the draft policies could have an effect of Europe being a hub for pharmaceutical innovation.
PhRMA and EFPIA issued its Principles for Responsible Clinical Trial Data Sharing in July, reflecting the biopharmaceutical sector’s strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for continued investment in biopharmaceutical research.
Biopharmaceutical companies believe that continuing augmentation of information available to researchers, patients and the public will expand research and scientific knowledge, foster a collaborative scientific discovery process, and support patient care – all with the ultimate goal of improving health.
Under the Principles, PhRMA and EFPIA member companies agree to:
- Enhance Data Sharing with Qualified Researchers: This includes patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the U.S. and EU. Requests are subject to terms necessary to protect patient privacy and confidential commercial information.
- Share Results with Patients Participating in Clinical Trials: Companies will work with regulators to provide a factual summary of clinical trial results to clinical trial participants.
- Enhance Public Access to Clinical Study Information: Synopses of clinical study reports for clinical trials in patients submitted to the FDA, EMA, or national authorities of EU member states will be publicly available upon approval of a new medicine or new indication.
- Reaffirm Commitments to Publish Clinical Trial Results: All company-sponsored clinical trials should be considered for publication in scientific literature regardless of outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
- Certify Procedures for Sharing Clinical Trial Information: Companies will certify on a publicly available website that they have established policies and procedures to implement these commitments
In light of the concerns raised in the Johnson, Pugatch and Taylor report PhRMA believes even stronger that the commitments made by our members is a more effective means in advancing science through enhanced data sharing than the EMA proposal.