A new report out of the U.K. has spotlighted the continuing opacity of clinical trial reporting, with nearly 60% of more than 4,200 studies not showing results within a year, as mandated by new rules in the U.S.
Researchers from the University of Oxford led by transparency advocate Ben Goldacre, M.D., found of the 4,209 trials registered on ClinicalTrials.gov that were due to report results, only 1,722 (41%) did so by the one-year deadline. More than a third of the trials (1,523) had still not been reported by Sept. 16, 2019.
This is despite new rules that began at the start of last year mandating these tests be shared within a year of completion, and the researchers argue regulators such as the FDA need to clamp down on this lack of reporting.
The research, published in The Lancet, found reporting of results was more common in trials with an industry sponsor (50%) than in those with a non-industry (34%) or U.S. government sponsor (31%).
Goldacre, who also co-runs the AllTrials lobby group, said: “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, despite all the levers available to them. Compliance will only improve when action is taken.
“Patients and clinicians cannot make informed choices about which treatments work best when trial results are routinely withheld. Clinical trials are not abstract research projects: they are large, expensive, practical evaluations that directly impact on patient care by informing treatment guidelines and evidence reviews.”
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The researchers warned: “Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help.”