Johnson & Johnson will make clinical data available to outside researchers

The announcement came on the same day that the Institute of Medicine, of the National Academy of Sciences, called on all sponsors of clinical trials to share detailed study data with outside researchers and recommended that such data be made available within 30 days of a product’s approval.

The dual developments are part of a broader shift toward making clinical trial data more publicly available and follows years in which the industry resisted calls to share its research with outsiders, claiming such moves would expose trade secrets and violate patient privacy.

Medtronic, another large device maker, had previously allowed Yale to evaluate data on a controversial spinal treatment, but the agreement with Johnson & Johnson is the first time a device manufacturer has made data available in a systematic way.

Johnson & Johnson agreed last year to work with Yale to share data about its drugs, and added devices and diagnostics to the agreement to deepen its commitment, Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said in an interview Tuesday. “We really believe that to advance science and to advance medical care, we wanted to take the next step,” she said.

Several researchers who have called for more openness in the past said they welcomed the announcements by Johnson & Johnson and the Institute of Medicine, but added that they would be watching closely to see how the initiatives were carried out.

“I’m very enthusiastic about this, and I hope that it will come to fruition in a way that’s really meaningful,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research and policy group. However, she said, “the devil is always in the details on this stuff.”

She and others said they were disappointed that Johnson & Johnson’s agreement does not include most products that are now on the market because it applies only to those approved since the beginning of 2014. She also noted that, because the Food and Drug Administration does not require that all medical devices undergo clinical trials before they are approved, the available data on these devices will be limited.

The agency does not require such studies for devices that manufacturers argue are updated products similar to previously approved devices. The flawed metal-on-metal artificial hips once sold by Johnson & Johnson — which led to serious injuries in patients and cost the company billions of dollars in legal settlements — were approved through the less stringent approval process.

“It will be fascinating to see what data are actually available,” Ms. Zuckerman said.

One example of a product for which data will be newly available is the Thermocool Smarttouch catheter, which is used to help treat patients with a heart arrhythmia known as atrial fibrillation. The product was approved in 2014.

Dr. Waldstreicher said the company would consider requests to study data for older devices. “If there’s an important medical question or an important public health question, we would absolutely be open to considering those requests,” she said.

The announcements on Tuesday follow years of pressure by advocates and researchers to persuade companies to share so-called patient-level clinical trial data, where personally identifiable information has been removed. For years, companies published summaries of the results of their trials in medical journals, but did so selectively and often did not make public studies that did not place their products in a positive light. But in recent years, that has begun to change.

“I think what’s remarkable is that we are now seeing very basic principles of the responsible conduct of research — which should best serve society — becoming mainstream by a whole range of organizations, including industry,” said Dr. Harlan M. Krumholz, a longtime advocate for data transparency who is director of the Yale University Open Data Access project, which is overseeing the Johnson & Johnson collaboration.

In a policy that takes effect this year, the European Medicines Agency, which oversees drug approvals in Europe, will publish detailed study data for every newly approved drug, and the American and European pharmaceutical trade groups have issued policies favoring data sharing. But adoption by individual companies has been sporadic, and their policies on making their data public vary widely.

The report by the I.O.M. seeks to standardize policies on data sharing, setting out specific timelines for when such information should be made public. It recommends that all sponsors of clinical trials publish detailed trial data within 18 months of completion of the study, or within 30 days of the product’s approval, whichever comes later. If a company decides to abandon development of a product, it should also make the full results of those trials available within 18 months. It also set out guidelines for how such sharing should occur, recommending that all requests for access be approved by an independent review panel that includes members of the public.

“The rapidly changing landscape of clinical trials and the movement toward greater transparency create a need to establish professional standards and set expectations of how to share clinical trial data,” Victor Dzau, president of the Institute of Medicine, said in a statement.

“An open data movement is really gaining momentum, but many people are still hesitant,” said Dr. Victor Dzau, president of the Institute of Medicine. “We need to develop a culture that supports data sharing, and we need to provide incentives and develop trust.”

In a statement, Jeffrey K. Francer, the senior counsel of the Pharmaceutical Research and Manufacturers of America, said the industry trade group supported the Institute of Medicine’s efforts.

Dr. Lisa Schwartz, a professor of medicine the Geisel School of Medicine at Dartmouth, said she welcomed the recommendations but noted that while the I.O.M. is influential, it has no power of enforcement.

“Clearly not everybody is going to listen,” she said. “But even if a lot of people listen, it seems like we’re still better off than we were before.

Source: The New York Times