PhRMA Conversations - Clinical Trials Data Sharing and Patient Privacy

Balancing the Public Health Benefit of Clinical Trials Data Sharing with Patient Privacy and Continued Innovation

08.27.13 | By John Castellani

Last month, PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) endorsed joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. At the time, I wrote that “these 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.”

The biopharmaceutical industry is hardly the only group with an interest in clinical trials data. Public health organizations, patient associations and academic researchers share our interest in finding solutions to complex medical challenges through the clinical research necessary to bring new medicines available for patients. Given different backgrounds and constituencies, opinions on how best to do so can differ.

That is the genesis behind this week’s question:

How do we balance the public health benefit of sharing clinical study information with the need to respect patient privacy and encourage continued innovation?

Given the nature of the question, we expected interesting and divergent responses from our diverse group of contributors. We were not disappointed.

Responding this week were Peter Pitts of the Center for Medicine in the Public Interest, Rebecca Li of Harvard University’s Multi-Regional Clinical Trials Center (MRCT), Kenneth Getz of the Tufts Center for the Study of Drug Development, and Douglas Peddicord of the Association of Clinical Research Organizations. The responses illustrate the complexities that accompany sharing clinical study data and I encourage you to read them in full.

Rebecca Li shares the principles that the MRCT identified as being critical to leverage the value of clinical data while protecting both patient safety and innovation.  Douglas Peddicord expresses concern that without guarantees of privacy, patients may be reluctant to participate in clinical trials. Without patients, there can be no clinical trials - and no new medicines.

Kenneth Getz argues that the traditional research and development framework is no longer viable in today’s quickly changing environment.  He suggests a more viable framework such as open innovation which depends upon collaborators sharing intellectual property and proprietary knowledge.

Peter Pitts cites the reams of information on and commends the Food and Drug Administration for its incremental and collaborative approach.

These are the types of discussions we had in mind when we launched the Conversations forum. Recognizing the different priorities of stakeholders in the health care ecosystem, disagreements are inevitable. These differences of opinion do not need to be a roadblock – instead they can help focus the discussion on shared goals and potential areas of compromise.

In this case, we all share the goal of advancing scientific knowledge to benefit patient care and public health while respecting the privacy of the patients who volunteer in clinical trials.   What clinical data is shared and with whom is still under discussion. 

We think we found the right balance in the new joint Principles for Responsible Clinical Trial Data Sharing. PhRMA and EFPIA member companies committed to enhance data sharing with qualified researchers, share results with patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results.

An ongoing and open discussion about the issue should bring us closer to a workable solution that, above all, benefits the patients of today and tomorrow.


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