European regulators urged to crack down on missing clinical trial resultsBMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1169 (Published 06 May 2021) Cite this as: BMJ 2021;373:n1169
- Gareth Iacobucci
- The BMJ
Transparency campaigners have urged national medicines regulators across Europe to take action to reduce the high number of unreported clinical trials.
An open letter1 to heads of medicines agencies signed by 18 organisations (see box), sent on 6 May, highlights that over 4000 drug trials run in the European Union (almost 30%) are currently in violation of EU transparency rules, which state that results have to be made public within 12 months.
The unpublished data “creates gaps in the medical evidence base that have significant potential to harm European patients, taxpayers, and public health,” warns the letter, coordinated by campaigning organisation TranspariMED.
National regulators within EU member states are responsible for ensuring that drug companies, …