Effective and responsible sharing of clinical trial data continues to expand scientific discourse and discovery, as we have chronicled here on the Catalyst.
Through the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing, the industry has made a firm commitment to publicize its research findings and created numerous avenues for qualified researchers to access this data.
Member companies such as Pfizer, Johnson & Johnson and GSK, among others, have robust data sharing mechanisms and most recently Astellas announced its participation in the independent online data hub ClinicalStudyDataRequest.com.
Recently, a New England Journal of Medicine study examined the reporting of clinical trial results for trials registered on Clinicaltrials.gov. The research covered the period between January 1, 2008, and August 31, 2012 and found that industry supported trials had the highest rate of results reporting, outpacing the reporting of National Institutes of Health (NIH) trials and other government or academic institution-funded trials.
It is important to note that the timeframe of this study predates the PhRMA-EFPIA Principles, so it is safe to conclude that even greater reporting of results is occurring today. Under the Principles, PhRMA member companies made the following commitments:
- 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 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 are 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 ongoing sharing of information among government regulators, the academic and medical communities, physicians and the public improves patient health and informs our understanding of disease and potential treatments. The biopharmaceutical sector is proud of its track record of cooperation and looks forward to continuing our collaborative work of researching new medicines to meet patient needs around the world.
Bill Chin, M.D. Dr. Bill Chin is the chief medical officer of PhRMA and leads the Scientific & Regulatory Advocacy department as executive vice president. A physician, an endocrinologist and an academic at heart, Dr. Chin envisions establishing PhRMA as the premiere convener in advancing drug discovery and development, regulatory sciences and collaborative partnerships.