The shift by Johnson & Johnson (NYSE: JNJ) to provide Yale University School of Medicine’s Open Data Access Project with de-identified data from clinical trials, conceived over a conversation between two Harvard Medical School classmates going for a walk, has huge ramifications for research scientists and patient groups. It also reflects a big change in the relationship between the life science industry and the patients it serves. Here are a few things that make this such an important step.
It provides access to data previously off-limits. As The New York Times pointed out in an editorial, more than half of the clinical trials in the United States, including many sponsored by academic and governmental institutions, are not published within two years of their completion. In many instances they are never published. That’s data that can be used to better ascertain the side effects of drugs. Eventually, the agreement says, it will make available clinical trial data from medical devices and consumer products of J&J companies.
It helps build trust in drug developers. The gesture is an important step in building trust between drug developers and the patient community and, if it goes according to plan, it will show they have nothing to hide. That kind of transparency is critical for improving how big pharma are perceived and could lead to greater interest in clinical trials. David Sell outlined the kind of social contract pharmaceutical companies have with society by way of a speech by Pfizer CEO Ian Read in which he said: “There is a perception gap” between image and the great value of good medicine. “It is vital to close that gap if this industry is to enjoy the support of society.” It also sends a message to patients that they are valued partners in these trials and have a right to their own data.
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It offers a great role model for the pharma industry. Although GlaxoSmithKline and Roche have made gestures to provide data from clinical trials to researchers, J&J’s move is unprecedented and other companies will be measured by it. Pfizer said in December that it plans to broaden access to information from its clinical trials to independent researchers and to patients who take part in the studies. J&J’s move could accelerate this effort and spur other companies to do more to share clinical data as well.
It would help scientists learn from mistakes. One of the things that pharmaceutical companies seem to fear most is making mistakes. But by providing access to clinical trial data, scientists could learn from these mistakes, and it could lead to improvements in clinical trial design, potentially reduce costs and build a stronger industry long-term.
[Photo of group of tiny people walking from BigStock Photos]
