Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study

The Lancet

17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. 

The Food and Drug Administration Amendments Act of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. 

In this cohort study, the investigators set out to assess compliance.

Read The Lancet article

Michael Wonder

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Michael Wonder