Rule on Reporting Clinical Trial Results Often Violated

Study finds fewer than half of trials followed the law

Less than half of clinical trial results are reported promptly on the U.S. trial registry ClinicalTrials.gov despite federal requirements, according to a recent study published in The Lancet.

U.S. regulations that took effect in January 2017 require clinical trials to report results on ClinicalTrials.gov within one year of completion. But just 41% of trials followed the rules, and one in three trials remains unreported. Trials with nonindustry sponsors (such as universities, hospitals, and governments) are far more likely to breach the rules than trials sponsored by industry—with trials sponsored by the U.S. government least likely to post results on time.

It has been known for decades that clinical trial results are often not fully reported, especially when trials find no evidence of effectiveness for the treatment being tested. To improve public disclosure and limit selective publishing of results, the U.S. Food and Drug Administration Amendment Act of 2007 requires sponsors of most U.S.-regulated clinical trials to register and report results on ClinicalTrials.gov within 12 months of primary completion, regardless of whether results are positive or negative. A “Final Rule” implementing the act took effect in January 2017 with clearer reporting requirements, including fines of up to $10,000 a day for noncompliance.

The authors say the high rates of noncompliance found in the study likely reflect the lack of enforcement by regulators, and they call for trial sponsors to be held to account by the FDA.

"Patients and clinicians cannot make informed choices about which treatments work best when trial results are routinely withheld," says lead researcher Ben Goldacre, MBE, of Oxford University. "Our study has identified over 2,400 trials breaching the rules, but to our knowledge the FDA has never levied a single fine or other enforcement action."

The first trials covered by the final rule were due to report in January 2018. The researchers examined all 4,209 trials registered on ClinicalTrials.gov that were legally required to report results between March 2018 and September 2019. They also assessed trends in compliance, factors associated with compliance, and ranked individual sponsors according to their level of compliance.

Of the completed trials included in the study, around half (52%; 2,178) had nonindustry sponsors, most involved a drug intervention (71%; 2,968), and most were solely conducted in the U.S. (71%; 3,000). Only 41% (1,722 of 4,209) of completed clinical trials reported results within the one-year legal deadline, while 36% (1,523 of 4,209) still had not been reported by September 16, 2019. The proportion of compliant trials has remained stable since July 2018.

Trials with an industry sponsor were much more likely to comply with the law (50%) than those with a nonindustry (34%) or U.S. government (31%) sponsor.

Source: The Lancet, January 17, 2020