Responsibly Sharing Clinical Research Results Will Enhance Scientific Knowledge and Advance Patient Care
Biopharmaceutical Companies Commitment Will Dramatically Increase Information Available to Researchers, Patients and the Public
07.24.13 | By John Castellani
The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. Today, PhRMA joins the European Federation of Pharmaceutical Industries and Associations (EFPIA) in strengthening our long-standing commitment by endorsing joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.
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. We firmly believe that continuing to augment the amount of information that is shared responsibly 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.
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. 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. Companies will work diligently to begin reviewing requests for data from researchers in January; however releases of patient-level data must take into account patients’ informed consent, and for many earlier trials, patients did not consent to such release. Biopharmaceutical companies will certify on a publicly available website that they have established policies and procedures to implement the principles.
These new Principles supplement PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results which were strengthened in 2009 to 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.
The biopharmaceutical industry is firmly committed to working with all stakeholders in the clinical trial ecosystem to advance responsible clinical trial data sharing and continually consider how to improve upon other aspects of the current clinical trial system. In addition to engaging in ongoing conversations with patient groups and academic research centers, we collaborate with groups such as the Institute of Medicine, Harvard Multi-Regional Clinical Trials Center, Project Data Sphere of the CEO Roundtable on Cancer, and the European Alliance for Personalized Medicine.
Clinical trials are not possible without the patients who volunteer to participate in them in order to explore new treatment options and to advance scientific knowledge. The new Principles represent the latest development in the biopharmaceutical industry’s long-term commitment to do just that by facilitating greater data sharing and collaboration in clinical research.