Failure to report clinical trial results is not a victimless crime. A 2017 report by Transparency International and Cochrane documents that a failure to fully report trial results has substantial negative consequences:
- Patients are harmed
- Public health agencies cannot make informed decisions
- Public health funds are wasted
- Medical progress is slowed down
Unreported trials contribute little to progress in science and public health and are therefore costly research waste. In the past, unreported clinical trial results have caused public health losses amounting to billions of Euros and have led to the deaths of countless patients. For this reason, the Declaration of Helsinki has made reporting the results of every clinical trial a universal ethical obligation for all medical researchers worldwide.
In 2014, the European Union (EU) adopted rules that require the sponsors of all clinical trials registered on the EU Clinical Trials Registry to post summary results to the registry within 12 months of trial completion (six months for paediatric trials). These rules also apply to trials completed before 2014 and apply irrespective of whether a trial’s outcomes have been published in the academic literature.
Our research showed that only one of the largest 23 clinical trial sponsors in the Netherlands is adequately managing its data on the European registry and systematically uploading trial results. Shockingly, only 3% of trials assumed to be completed had results shared in the registry.
Download the full report (PDF)