In theory, ClinicalTrials.gov plays an important role in the world of medicine. The federal government-run website says its purpose is to provide "easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions." Doctors, researchers, patients, and others count on that data to help them determine how well a drug or medical device works, and whether using it carries safety risks that might outweigh benefits. Interest in the site is high, as evidenced by the astonishing 207 million monthly page views it generates.
But a newly published investigation by STAT — Boston Globe Media's online health and life-sciences publication — raises questions about the database's usefulness, and whether it's being undermined by medical research institutions and drug companies. STAT reporter Charles Piller found that most recipients of research funding from the National Institutes of Health and the drug industry do not comply with a law requiring them to report results from clinical studies within a year after a study's conclusion. The prestigious Memorial Sloan Kettering Cancer Center, for instance, didn't file results for a drug tested on patients with breast and colorectal cancer. Thirteen of 37 patients in two trials of the treatment suffered serious side effects, and one died.
Even the NIH's own researchers often failed to meet the reporting law's deadlines.
Violators are subject to fines, but STAT found none have been assessed since result reporting became a requirement in 2008. Equally troublesome, academic institutions — including Memorial Sloan Kettering, New York University, and Stanford University — had a worse track record for compliance than drug manufacturers. In 90 percent of cases, they reported trial results late, or not at all.
Research institutions gave a variety of reasons for their failure to meet filing requirements. Mainly, they blamed it on too much paperwork for their modest-size staffs. Others said the publication of test results in peer-reviewed journals essentially serves the same purpose as ClinicalTrials.gov. But those journals reject many papers submitted by researchers, and they don't usually publish findings on small-scale trials, or those that yield poor results. Papers that do get published frequently don't include the kind of comprehensive information the government website was created to handle. Besides, patients typically don't subscribe to — nor can they afford — expensive medical journals.
To ensure ClinicalTrials.gov's credibility, it's critical to bring researchers and drug makers into compliance. The NIH can enforce the reporting law by cutting off funding for research institutions that don't adhere to the rules, or by denying funds for further testing. The Food and Drug Administration, which oversees drug and device makers, can assess fines against firms that skirt the law. NIH Director Dr. Francis Collins promises that such enforcement actions are on the horizon.
Additionally, some existing exemptions to the reporting regulations that undercut the website's effectiveness should be eliminated. In particular, requests by researchers to delay reporting results — a common practice of drug companies – should face tougher scrutiny, and not be approved out of hand. The law also should be changed to require results from early-stage trials of experimental drugs that have been abandoned. That would create a data trail in the event another research organization starts a separate study of a similar compound.
ClinicalTrials.gov was launched with admirable intentions. Incomplete reporting undermines its mission, and does the public a disservice.