Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving
THURSDAY, Jan. 23, 2020 (HealthDay News) — Compliance with the U.S. Food and Drug Administration Amendments Act of 2007 is low, with only 40.9 percent of trials reporting results within one year, according to a study published online Jan. 17 in The Lancet.
Nicholas J. DeVito, M.P.H., from the University of Oxford in the United Kingdom, and colleagues examined compliance with the FDA Amendments Act of 2007, which requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within one year of completion. The act was implemented in January 2017, with trials due to report results in January 2018.
The researchers found that 40.9 percent of the 4,209 trials that were due to report results did so within the one-year deadline; 63.8 percent of trials had the results submitted at any time. Since July 2018, compliance has not improved. Compliance was more likely for industry sponsors versus nonindustry, non-U.S. government sponsors (odds ratio, 3.08) and for sponsors running large numbers of trials versus smaller sponsors (odds ratio, 11.84). From primary completion date to submission, the median delay was 424 days.
“Compliance with important U.S. rules on clinical trial reporting has been poor, and is not improving,” the authors write. “Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor could help.”
Copyright © 2020 HealthDay. All rights reserved.