Last week, Johnson & Johnson (J&J) announced a new partnership between its subsidiary, Janssen Research and Development, and the Yale School of Medicine’s Open Data Access (YODA) project, in which Janssen will release its anonymized clinical trial data to the research community. YODA will serve as the independent reviewer of requests from researchers for Janssen’s clinical trial data, including clinical study reports and anonymized patient-level data, and will have the final decision on whether data is shared.
Over the past 12 months, numerous companies - GSK, Boehringer Ingelheim, ViiV Healthcare, Sanofi, and Roche – have moved toward greater data transparency. In 2011, Medtronic partnered with YODA for the review of its recombinant human bone morphogenetic protein-2 (rhBMP-2). J&J’s move is unusual compared to these prior activities in that it is the first time a manufacturer has partnered on this large of a scale with an independent third party to manage access to all of its clinical trial data.
Coupled with the push by EMA to require manufacturers to release clinical trial data to researchers once medicines have been approved, manufacturers will likely feel pressure to enter into these types of partnerships. In fact the IOM has put forth a discussion framework for clinical trial data sharing including guiding principles and definitions and is requesting public comment until March 24. Finally, policies that make available data collected in the course of patient care and allow researchers, including industry, to analyze these data will also add to creating a more transparent and thus, trusting research environment while also supporting incentives for innovation.
To view my previous work on this subject on the Health Affairs Blog, click here.
For more information on data transparency, please reach out to me directly at TCarino@Avalere.com.