Outside Researchers Will Now Have Access to JNJ Clinical Data

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

Medtronic Inc. previously had allowed Yale to evaluate data on a controversial spinal treatment, but the Yale University Open Data Access (YODA) Project agreement with JNJ 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, JNJ Chief Medical Officer Dr. Joanne Waldstreicher told The New YorkTimes. “We really believe that to advance science and to advance medical care, we wanted to take the next step,” she said.

The YODA Project will act as a bridge between investigators and JNJ’s pharmaceutical and device and diagnostics businesses. Under the arrangement, the YODA Project will approve or deny requests from investigators for de-identified patient data associated with the pharmaceutical, medical device, and diagnostic clinical trials conducted by Johnson & Johnson companies.

“This action will benefit society and represents a major step forward in the effort to promote data sharing, as Johnson & Johnson’s leadership in this area now extends from sharing its drug data to sharing its device and diagnostics data,” said Dr. Harlan Krumholz, professor of medicine and leader of the YODA Project. “We hope this action serves as a catalyst to others to join the momentum on open science.”

JNJ’s agreement with Yale does not include most products that currently are on the market because it applies only to those approved since the beginning of 2014. And since the U.S. Food and Drug Administration (FDA) does not require all medical devices to undergo clinical trials before approval, available data on these devices will be limited, observers noted.

The FDA does not require clincial studies for devices that manufacturers claim are updated products similar to previously approved devices. The flawed metal-on-metal artificial hips once sold by J&J— which led to serious injuries in patients and a costly recall—were approved through the less stringent approval process.

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 told the Times.

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

 

“Data sharing maximizes knowledge generation from clinical research studies, enabling multiple investigators to use the data for additional research projects. Through sharing of clinical trial data for medical devices, we can now learn more about these important medical treatments,” said Dr. Joseph Ross, associate professor of medicine and member of the YODA Project.

Requests for data may be directly submitted to the YODA Project through its website.