Intended for healthcare professionals

Editorials

New EU trial reporting regulations must be enforced

BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o410 (Published 18 February 2022) Cite this as: BMJ 2022;376:o410
  1. Nicholas J DeVito, doctoral researcher,
  2. Ben Goldacre, senior clinical research fellow
  1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  1. Correspondence to: N J DeVito nicholas.devito{at}phc.ox.ac.uk

Trial reporting is now the law, but change will come only if regulators and institutions act

In the mid-1980s, Australian epidemiologist Robert Simes called for an international system of prospective clinical trial registration to tackle prevalent non-publication of results.1 Trial registries have since become a key regulatory tool. Nonetheless, gaps remain: the best current evidence shows that trial results are commonly withheld or incompletely reported.23

Europe’s latest transparency effort is Clinical Trials Regulation 356/2014, which covers “clinical trials of interventional medicinal products” (meaning most human drug, vaccine, and biological medicines research) and legally requires technical and lay summaries of results to be reported within a year of trial completion. The regulation came into effect with the launch of the Clinical Trials Information System (CTIS) in January 2022, eight years after it was first approved. The CTIS will act as a regulatory portal, trial registry, and results repository. This should help improve transparency as well as making trial authorisation more efficient and reducing administrative burden for sponsors.4

Past EU efforts to improve clinical trials …

View Full Text

Log in

Log in through your institution

Subscribe

* For online subscription