Mandate Will Ensure Researchers, Companies Report Clinical Trial Data, Says Collins

At the Cancer Moonshot Summit, Vice President Joe Biden cautioned research scientists to expect funding cuts if they failed to report, in a timely manner, the findings of clinical trials.

According to STAT news, Biden warned researchers, “Under the law, it says you must report. If you don’t report, the law says you shouldn’t get funding. I’m going to find out if it’s true,” he said about researchers failing to report trial data, “and if it’s true, I’m going to cut funding. That’s a promise. If the National Institutes of Health (NIH) maintains a follow up on the reporting, it could considerably impact the pace of research by improving data access to others who might be looking for pertinent information. It can also allow patients earlier access to drugs and could guide physicians on potential treatment options for their patients.

Once this proposal becomes a rule, NIH will have the authority to crackdown on institutions that fail to update trial results, Francis Collins, MD, director of NIH told reporters after the Summit. “That final rule is close to appearing, and we can basically say to Harvard, ‘Sorry, we’re not giving you any dollars until this principal investigator who ran a clinical trial deposits the data,’” he said. The FDA will wield equal power on companies it regulates, to impose a $10,000-a-day fines if they fail to abide by reporting rules, according to Collins.

An investigation by STAT, published late last year, identified about 9000 trials—initiated on or before September 27, 2007—that had failed to submit results within 12 months of the trial conclusion date. These trials were conducted at well-reputed institutions including Stanford University, Memorial Sloan Kettering Cancer Center, and the University of Pittsburgh.

Accountability is key for ensuring appropriate disbursement of trial results, according to Ben Goldacre, MD, a fellow at the University of Oxford and a cofounder of AllTrials, an international initiative that demands complete transparency in reporting the methods and results of past and present clinical trials. “The only point of funding a trial is to get the results, it’s mind-blowing that funders tolerate results being withheld. (M)aking funding contingent on actually sharing your results, and ideally your data, is vital. If NIH can lead on this, then other non-governmental funders will hopefully follow,” Goldacre told STAT.

During his speech, the Vice President stressed on identifying ways to get rid of these practices. “The impediment isn’t the lack of gray matter genius and ingenuity… It’s all this stuff that gets in the way,” Biden said. “We have to figure out how to get out of the way, and you guys have to figure out how to get in each other’s way more.”