Preregistration and publication of nonregulated intervention trials are here to stay (letter commenting Wallach et al 2018, 93, 88-93)
In their timely and interesting article, Wallach et al. [1] discussed, among other relevant topics, prospective registration of most interventional studies (i.e., clinical trials) of drug, biological and device products regulated by the US Food and Drug Administration, and the mandatory requirement to report trial results on clinicaltrials.gov. The se requirements are also mandatory in the European Union: sponsors are required to preregister and to post medicines trial results on European Union-Clinical Trials Register.
Source: Journal of Clinical Epidemiology - Category: Epidemiology Authors: Rafael Dal-R é Tags: Letter to the Editor Source Type: research