J&J Opens Clinical Trial Data in Yale Collaboration

Jan 31, 2014 7:23 am ET

(Corrects story published Jan. 30 to remove reference in first paragraph to J&J being first to grant access to trial data; corrects 10th paragraph to remove incorrect reference to Justice Department.)

Jan. 30 (Bloomberg) -- Johnson & Johnson will give academics access to data on clinical trials, a move that may prompt more companies to do the same.

The collaboration with Yale University’s Open Data Access Project, or YODA, gives the school power to release years of J&J drug findings to outside researchers. Harlan Krumholz, the Yale researcher leading the project, said it will open up a world of information about how drugs work, and their risks and benefits.

While the U.S. has required the registration of clinical trials since 1997, drugmakers still have wide latitude on deciding what data from those tests they will disclose to the public. That created an opportunity to hide failures and lackluster results that advocacy groups said may have been useful to ensuring patient safety.

“There are great insights that are residing within these data,” Krumholz, a professor at the Yale School of Medicine in New Haven, Connecticut, said in a telephone interview. “It really will be game-changing.”

The increased transparency by New Brunswick, New Jersey- based J&J, the world’s biggest maker of health-care products, may prompt other drugmakers to do the same. Krumholz, without naming any, said he has reached out to other companies before and some “are reluctant to give up the control.”

J&J shares rose less than 1 percent to $89.50 at the close in New York.

Negative Findings

GlaxoSmithKline Plc was the first major drug company to make its trial data available. Glaxo has received 16 requests for data through November, approving 12 while the rest are in process, said Melinda Stubbee, a spokeswoman for the London- based company.

J&J, which makes the rheumatoid arthritis treatment Remicade, prostate cancer treatment Zytiga and blood thinner Xarelto, plans to start with its drug trials, then open up medical device and consumer health product information to YODA.

“We have nothing to hide and if new findings come out -- positive or negative -- all the better,” said Joanne Waldstreicher, J&J’s chief medical officer.

With YODA, researchers will have the opportunity to look further into J&J’s data than what the drugmaker may have published in a clinical trial result, searching for which patients benefit most, or for side effects that are more common in one group or another.

Krumholz said that may lead to insights like what researchers found after they looked at digoxin, a heart drug studied by the U.S. National Institutes of Health. A decade after the NIH found the medicine safe and beneficial, Krumholz and fellow researchers delved back in for another look. In a 2002 study published in the New England Journal of Medicine, they found the product may harm women more often than men.

“Those studies ended up shaping how people thought about that drug,” Krumholz said.

Medtronic Inc., the biggest maker of heart-rhythm devices, was the first medical company to give Yale access to similar data when it asked Krumholz’s group to review a trial of its bone graft product, Infuse.

YODA Program

To get the J&J data, researchers will apply to the YODA program. A board composed of non-J&J advisers will review requests and decided whether to release the information. If approved by YODA or the board, they’ll get access to detailed information to the level of the individual patient, although the patients’ privacy will be protected.

The agreement with J&J came together at an October 2012 conference in Washington. Krumholz and Waldstreicher had attended medical school together at Harvard University. Krumholz was giving a talk on data transparency while Waldstreicher was in the audience.

“We’re friends,” Krumholz said, and afterward, they talked. “I said, ‘I wonder if you guys would be willing to take a bold action and become leaders in this area.’”

Waldstreicher and J&J were. “I have a lot of respect with the approaches of other companies,” she said, yet “we really thought we wanted to start from scratch.”

--With assistance from Makiko Kitamura in London. Editors: Angela Zimm, Andrew Pollack