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Increasing Clinical Trial Data Transparency

Increased collaboration and knowledge sharing has the potential to drastically increase the rate of innovation in the life science industry. A current focus in the biopharmaceutical space is the need for increased clinical trial data transparency. Proponents of increased data sharing advocate that high quality analysis of clinical trial data will benefit public health by furthering our understanding of diseases and their treatments. However, some companies are more reserved, concerned they may lose competitive advantages gained from knowledge acquired during clinical trials.

This year, on January 1, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) implemented the Principles for Responsible Clinical Trial Data Sharing. The principles include safeguarding the privacy of patients, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research. By embracing these principles, EFPIA, PhRMA, and their member companies have declared commitments to the following initiatives:

  • Sharing patient- and study-level clinical trial data, as well as clinical trial protocols, for medicines and indications approved in the US and the EU with qualified scientific and medical researchers conducting legitimate studies, upon request.
  • Making the synopses of clinical study reports (CSRs) for newly approved medicines or indications publicly available in order to help patients and healthcare professionals understand the results of clinical trials and the evidence used to approve the new medicine.
  • Providing factual summaries of clinical trial results to the participants of the trials in order to keep them informed of those in which they participated.
  • Reaffirming their commitments to publishing the clinical trial results of significant medical importance for all three phases of trials.

Since the implementation of these principles, several pharmaceutical companies belonging to PhRMA have already announced new procedures demonstrating their follow through. Leading the charge is Johnson & Johnson, who established a partnership with the Yale School of Medicine’s Open Data Access (YODA) Project; YODA will serve as the independent body that oversees requests from researchers for access to anonymized clinical trial data from J&J’s Janssen business unit. Having an independent third-party assess these data requests is J&J’s effort to be systematic and objective when determining with whom to share data. This is in contrast to companies like Roche, who established their own independent panel of experts to evaluate these requests. In addition, J&J has been bold enough to say that it will honor retroactive scientific data requests, as long as the data is available.

Regardless of the method used to demonstrate transparency, the challenge for life sciences companies is determining how to share this data effectively (in a form that is digestible for the public), while also protecting their patients’ privacy and any valuable knowledge afforded from the clinical trial results.

Tags: Data Integrity