The biopharmaceutical industry remains committed to enhancing public health through responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.
In July 2013, PhRMA joined with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in adopting joint Principles for Responsible Clinical Trial Data Sharing. These Principles dramatically increase the amount of information available to researchers, patients, and members of the public.
Key commitments of the Principles include:
- 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 United States and EU will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.
- Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.
- The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
- Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
The Principles are being implemented by biopharmaceutical companies in the U.S. and Europe. Examples of industry data sharing programs include:
- Pfizer created a comprehensive data access policy and web portal to facilitate requests from researchers, trial participants, regulators, and others acting in the best interest of patients seeking access to clinical trial information to advance medical understanding and progress.
- The GlaxoSmithKline (GSK) Clinical Study Register provides an easily accessible repository of data from GSK-Sponsored clinical studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information.
- Johnson & Johnson partnered with the Yale School of Medicine’s Open Data Access (YODA) Project which serves as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, the pharmaceutical companies of Johnson & Johnson, and make final decisions on data sharing.
- EFPIA maintains a Clinical Trial Data Portal, offering easy access to member companies’ online trial data sources.
Continuing to augment the amount 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 public health.
Topics: FDA, PhRMA Member Company, Intellectual Property, Clinical Trials