Drug Firms Open Up on Trial Data Sharing

Facing mounting pressure for transparency in biomedical research, members of two major drug industry trade groups have agreed to make anonymized, patient-level clinical trials data available for public scrutiny, under certain conditions, on a voluntary basis.

The drug industry has long resisted demands for increased access to its trial data, claiming that releasing the data could give away key information to competitors, among other consequences.

However, by committing to the “Principles for Responsible Clinical Trial Data Sharing” announced in July by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), drug companies now say they will release patient-level information to researchers they deem qualified to receive it, after review by a board of external experts.

Outside researchers traditionally receive access only to summary clinical trial data. Patient-level data relating to the individual characteristics and responses of study participants typically remain out of public view.

Given that limitation, scientists can't readily discern how patient-level information leads to summary conclusions, comments Deborah Zarin, MD, director of clinicaltrials.gov and author of a recent editorial about trial transparency in the New England Journal of Medicine.

Access to data released based on these new principles, Zarin says, should allow scientists and other members of the public to more easily connect the dots between patient-specific and summary results. But Zarin cautions that many questions about how the principles will be implemented remain unanswered.

“The devil is in the details,” she says. “For instance, companies have stated they will only release the data for drugs with approved marketing indications. Is that for approved indications anywhere in the world or only in certain places? Will they release data for studies that are never published? How long after publication will they release the data?”

“The new disclosure efforts,” Zarin adds, “should be accompanied by a useable online system for determining data availability for each clinical trial.”

Cindy Geoghegan, a principal and cancer patient advocate with Patient & Partners, LLC, in Madison, CT, expresses concern over how qualified research recipients will be selected. “As patients, we want our data and participation in clinical trials to be leveraged, shared, and utilized to their fullest potential,” she says. “Who will determine what constitutes a valid research proposal? The last thing we need is another obstacle to public access.”

In addition to sharing data with researchers, the two trade groups also have committed to making summaries of clinical study reports more available to patients and physicians, which Geoghegan describes as a step in the right direction.

In many cases, she says, patients and community physicians lack even basic information about trial outcomes that is available to the research community. “By committing drug companies to share summary results with trial participants, the principles might improve clinical decision making among doctors and the broader patient community,” Geoghegan says. “As advocates we want to foster efforts to disseminate trial data so that it can improve the efficiency and effectiveness of future research.”

Approved unanimously by PhRMA and EFPIA member companies, the principles are due to take effect on January 1.