Most clinical trial results not reported within ClinicalTrials.gov guidelines

Although pharma companies are required to report clinical trial results to ClinicalTrials.gov in a timely manner, research published in the New England Journal of Medicine suggested that the majority of results are not submitted.

The analysis covered 13,327 trials that were terminated or completed between January 1 2008 and August 31 2012, and were likely to be subject to provisions under the FDA Amendments Act. Within this, 77.4% were classified as drug studies, 36.9% were Phase II studies, and 23.4% were in Phase III.

Sponsors of most trials are required to start registration and reporting of basic summary results to ClinicalTrials.gov within one year of completing data collection, with the mandate applying to non-Phase I trials of drugs, biologics or medical devices with at least one research site in the USA. The analysis, however, found that only 13.4% of eligible trials reported findings within the one-year window.