“This is a remarkable action by Johnson & Johnson that should accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing,” Dr. Harlan Krumholz, director of the YODA Project, said in a press release. “By establishing this fair and independent process to release data, Johnson & Johnson has taken a leadership position in this emerging era of open science.”
In 2011, Medtronic was the first to collaborate with Yale on this novel approach to evaluation and transparency. The Minneapolis-based devicemaker provided a $2.5 million grant to the medical school to conduct two independent, third-party systematic reviews of the safety and effectiveness of a product that stimulates bone formation. The reviews found that the product didn't meet expectations, according to results published in June.
In the J&J collaboration, however, the company has committed to releasing data for all its products.
Several groups in the U.S. and Europe have been working on policies and collaborations to address growing criticisms over the lack of transparency and access to critical information from clinical trials that is often considered proprietary. There are various data-sharing policies in effect at the National Institutes of Health. The pharmaceutical company GlaxoSmithKline started clinicalstudydatarequest.com in 2013, and according to the company's website, Boehringer Ingelheim, Roche, Sanofi and ViiV Healthcare have committed to the effort. In Europe, the website alltrials.net launched last year, asking for all past and present trials to be registered and their results reported. The European Medicines Agency established an “access-to-documents policy” in 2010, which was met with resistance from the industry.
Advocates say increased access to raw data is a huge step forward in terms of being able to understand efficacy and safety. Many, though, note that details vary widely in the surge of new policies and initiatives.
To address what they refer to as the “daunting” task of proposing an approach that works for the wide range of clinical trials and among stakeholders with interests that are not always aligned, the Institute of Medicine put out an all-call asking experts for feedback on key concerns, such as increasing transparency, maintaining patient privacy, protecting intellectual property and building public trust in research results. The committee aims to issue final recommendations on clinical trial data sharing by the end of the year.
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