The US requirement to deposit trial data within a year is unworkableBMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6449 (Published 01 November 2013) Cite this as: BMJ 2013;347:f6449
- Curtis L Meinert, professor, Epidemiology, Johns Hopkins University, Baltimore, Maryland 21205, USA
A provision of the US Food and Drug Administration Amendments Act of 2007 (section 801) requires that sponsors or investigators summarise results on ClinicalTrials.gov for drug and device trials within one year of the date of completion.1 The “date of completion” is defined as “the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.”
The act requires results to be summarised in tabular format, without discussion or conclusion. Sponsors or investigators may be granted extensions to the deadline if they can give reasons and the dates when they will provide results. Sponsors or investigators who fail to comply are subject to substantial fines.
The effect of the amendment is to force investigators to make data available before they have been finalised, …