Immeasurable Benefits for Research
An Important Week for Responsible Clinical Trial Data Sharing
10.22.13 | By Jeff Francer
This year, biopharmaceutical companies committed to transforming how their clinical research can be used to advance innovation for patients through careful sharing of clinical trial data with independent researchers.
Adoption of the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers is a landmark step toward more collaborative development, and implementation by biopharmaceutical companies and other research sponsors can lead to immeasurable benefits for research.
While we all recognize that enhancing research collaboration can bring great benefits, research sponsors and government regulators must be careful stewards of the personal health information they collect about clinical trial participants. We have a critical responsibility to ensure that patient privacy and informed consent are respected. In addition, we should mitigate risks to public health from the possibility of “junk science” that may lead to patients forgoing care that they need. Finally, we must make sure that data disclosure requirements don’t destroy the incentives that companies require for making the costly, long-term investments in medical research necessary for the development of new medicines.
This week, the Institute of Medicine of the National Academy of Sciences will hold a public meeting to examine the benefits and risks of clinical trial data sharing. In addition, the New England of Journal of Medicine (NEJM) has published a unique multi-disciplinary article that examines different models for responsible clinical trial data sharing. Full disclosure: I’m one author of this article in which we collaborated with physicians and attorneys through the Harvard Multi-Regional Clinical Trial Center to outline different models for clinical trial data sharing. Biopharmaceutical companies’ data sharing commitments contained in the PhRMA-EFPIA Principles line up favorably with many aspects of the models recommended in the NEJM article, including through the use of a scientific review board to review research proposals calling for patient-level data or complete clinical study reports.
PhRMA and our member companies are an integral part of the biomedical research ecosystem, and we believe that research sponsors, including government sponsors and academia, can effectively share their data with other researchers in a way that respects patient privacy, the integrity of the regulatory system, and the need to protect incentives for private investment in research – including confidential commercial information. We will continue to evolve and interact with the patients, physicians, universities, and hospitals that are the lifeblood of research.
As biopharmaceutical companies begin implementation of the PhRMA-EFPIA clinical trial data sharing commitments in January 2014, they will strive to remain careful stewards of research data and to engage in purpose-driven collaboration that serves patients and preserves the ability of research sponsors to continue to make the enormous investments necessary to bring new medical advances to those in need.