The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) recently endorsed Principles of Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. Under these new principles, biopharmaceutical companies will increase the amount of information available to researchers, patients, and the public. Among other things, the principles call for:
- The exchange of study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and the European Union with qualified scientific and medical researchers of patient-level clinical trial data.
- The distribution of factual summaries by companies working with regulators 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 US Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made public upon approval of a new medicine.
- Biopharmaceutical companies will publish clinical trial results regardless of the outcome.
To learn more about the principles go to the EFPIA website.