Principles for Responsible Clinical Trial Data Sharing
The biopharmaceutical industry is firmly committed to enhancing public health
The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. In July 2013, PhRMA joined with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in adopting joint Principles for Responsible Clinical Trial Data Sharing.
[Read the joint press release announcing the Principles]
The Principles reflect the biopharmaceutical sector’s strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.
Biopharmaceutical companies already routinely collaborate with academic researchers, publish clinical research, and share clinical trial information on public websites such as ClinicalTrials.gov. The Principles will enhance those efforts by making additional information available to the public, the patients who volunteer to participate in clinical trials, and qualified researchers.
PhRMA firmly believes that continuing to augment the amount of information available to researchers, patients and the public will expand research and scientific knowledge, foster a collaborative scientific discovery process, and support patient care – all with the ultimate goal of improving public health.
Under the Principles, PhRMA and EFPIA member companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results.
Implementation of the commitments in the Principles for Responsible Clinical Trial Data Sharing begins on January 1, 2014. At that time, companies will begin reviewing requests from researchers. Releases of patient-level data must take into account informed consent and patients who volunteered in earlier clinical trials may have not consented to such release. Biopharmaceutical companies will certify on a publicly available website that they have established policies and procedures to implement them.
These new Principles supplement PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results which help assure that clinical research conducted by America’s biopharmaceutical research companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients. These Principles include enhanced standards for medical research authorship and improved disclosure to better manage potential conflicts of interest in medical research.