Commitment to Data Sharing
Companies Continue to Implement Clinical Trial Data Sharing
01.30.14 | By Mark Grayson
As of January 1, researchers are now able to submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines approved in the U.S and EU after January 1, 2014. The biopharmaceutical sector’s commitment to data sharing provides new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and incentives for companies to make long-term investments in biomedical research.
Through these new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients and members of the public.
As an example of what companies are doing, Johnson and Johnson announced today an agreement with the Yale School of Medicine’s Open data Access (YODA) Project to serve as an independent body to review requests from investigators and physicians seeking access to anonymized clinical data and make final decisions on data sharing. Under the agreement, YODA will independently review and make final decisions regarding all requests for the company’s clinical trial data. The final decision on data sharing will be made by YODA. J&J also committed to the sharing of clinical trial data from its medical device and consumer products companies.
Biopharmaceutical companies already routinely collaborate with academic researchers, publish clinical research and share clinical trial information on public websites such as ClinicalTrials.gov Other PhRMA member companies, such as Pfizer, GSK, and Sanofi have also published their procedures for sharing data.
The EFPIA-PhRMA 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 beginning this year 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 expected to publish their findings.
- Companies will work with regulators toward a mechanism to provide factual summaries 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 also reaffirm their commitment to publish clinical trial results regardless of the outcome of the trials. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
These commitments build on the ongoing industry collaboration across the scientific ecosystem and recognizes the importance of responsibly sharing clinical trial data in the best interest of patients. Imperative to the success of these Principles are the safeguards that ensure patient privacy, respect the integrity of regulatory systems worldwide and foster ongoing medical innovation.