In a move toward greater transparency in drug research, Johnson & Johnson has signed pact with Yale University under which the company will share detailed clinical trial data from hundreds of drugs and other products with outside academic researchers.

The Wall Street Journal has a report detailing the agreement.

Under the unusual arrangement, Yale will vet proposals from scientists who want to conduct safety, efficacy and other studies of the treatments and determine, without input from J&J, which researchers will be given access to the clinical data.

“The medical scientific community and population at large want to have more transparency on what we do,” said Paul Stoffels, J&J’s chief scientific officer and world-wide chairman for pharmaceuticals. “To get really credible, we took the leap” to set up an “independent way to make sure people get access to the data.”

In addition to trying to restore trust in the data, the effort is expected to help advance medical science, the company said. Independent researchers, for instance, might scour the data for subgroups of patients more likely to benefit from a drug, or be at heightened risk of side effects.

The move is the latest and one of the boldest efforts by the pharmaceutical industry intended in part to help build confidence in the reliability of clinical data supporting approval of its medicines. Over the past decade, drug companies have often been embroiled in controversies over whether published studies overstate the benefits of drugs and, especially, whether negative findings are hidden or played down, leaving doctors and patients with an incomplete picture on the risks and benefits of medicines.

Such episodes have prompted calls for more disclosure on the conduct of studies and publication of their results. All clinical trials are now required to be registered in advance on the government website Clinicaltrials.gov, and most medical journal editors won’t publish results from unregistered studies.

For the industry’s part, this month a joint project by the two leading industry trade groups—Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations—began an effort called Principles for Responsible Clinical Trial Data Sharing to make more clinical trial data available to outside researchers.


 
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