The two pharmaceutical industry bodies, European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), have published their common “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers”
In summary, the commitments underlined in this document are to:
- Share with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information, 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 European Union. 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;
- 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.
Implementation of the commitments will begin on 1 January 2014.