Researchers conducting applicable clinical trials are required to post their study results within one year, but compliance with this requirement is very poor, according to a new study published in The Lancet.
Sponsors of applicable trials are required to report trial results online to ClinicalTrials.gov within a year of completion.
Not reporting clinical trial results can have a negative impact, by distorting the evidence base for the clinical practice, break ethical obligations between researchers and participants and simply waste research resources. The final rule went into effect January 20018.
Researchers downloaded data for all registered trials on the government website on a monthly basis from March 2018 to September 2019, including all applicable trials due to report results under the law.
Of those analyzed, 4,209 trials were supposed to post their results, but only 1,722 did so within the one-year deadline, the study found. That’s only 41%, and about one-third of the trials, or 1,523, didn’t report at all as of Sept. 16, 2019. The median delay was 424 days––59 days longer than the legal requirement of one year.
Since July 2018, compliance also did not improve, the researchers noted. However, industry sponsors were more likely to post their trial results within the one-year deadline compared to non-industry, non-government sponsors. In addition, sponsors with large numbers of trials were “significantly” more likely to comply with the requirement than smaller sponsors, researchers found.
“Poor compliance is likely to reflect lack of enforcement by regulators,” wrote first author Nicholas J DeVito MPH, of the University of Oxford un the U.K., and colleagues. “Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help.”