Today, a study published in the British Medical Journal (BMJ) sought to audit industry clinical trial disclosure and data sharing policies. The study, entitled Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study, and authored by affiliates of the AllTrials organization, looked at company policies with regard to registration, methods and summary results, CSRS and individual patient data.
The biopharmaceutical industry has long-established commitments to transparency throughout the lifecycle of a clinical trial including registration, results reporting and data sharing. PhRMA and its member companies are committed to enhancing public health and advancing medical research by sponsoring and conducting clinical research that fully complies with all legal and regulatory requirements. The work protects the safety of research participants and shares responsibly clinical trial data in a manner that is consistent with the need to safeguard patient privacy. As such, PhRMA and its member companies would welcome further dialogue with AllTrials and the study authors about their recent publication, particularly focused on their methodology and some of the conclusions that they reach.
The biopharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data. Further, it has led the way in sharing patient-level data, and industry’s commitments are reflected in the joint PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing. Under these Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to the clinical study information and reaffirm their commitment to publish clinical trial results.
Together with EFPIA, PhRMA recently conducted a survey to assess the degree to which member companies had implemented the commitments under its Principles, the results of which will be officially released in the near future. The survey results show that 98 percent of our members share clinical trial data beyond any legal or regulatory requirements. Our members accomplish this in a variety of ways, including participation in an external data sharing platform, publication of trial results in the scientific literature, posting clinical trial information on their own websites and sharing data with qualified researchers through direct dissemination. In addition, PhRMA and EFPIA member companies collectively approved 80 percent of the approximate 1,000 requests received for access to clinical trial data.
The biopharmaceutical industry believes that disclosure of clinical trial results and appropriate sharing of clinical trial data is in the best interests of patients, clinicians, medical research and the biopharmaceutical industry. PhRMA members have made significant progress in developing processes for clinical trial data access schemes and translating principles into practice.
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Olivia Shopshear Olivia is a director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical product development to commercial tech transfer to global supply chain management. She currently leads PhRMA’s clinical trial data transparency advocacy program.
Topics: Clinical Trials