A new report by Health Action International (HAI) and TranspariMED published today reveals the shocking failure of clinical trial sponsors in the Netherlands to meet their obligations to publish the results of their research.
In assessing the performance of 23 Dutch companies, universities, hospitals and research institutions most active in conducting drug trials, the HAI/TranspariMED research showed that just one was adequately managing its data on the European Clinical Trials Registry. Shockingly, only 3% of trials assumed to be completed had shared results in line with European Union transparency rules.
Failure to report clinical trial results is not a victimless crime and can lead to a number of negative consequences, including:
- 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.
HAI Senior Policy Advisor, Jaume Vidal, said:
“Reporting the results of clinical trials, whether positive or negative, contributes to advances in research and inspires trust in the efficacy of marketed drugs. It is a matter of concern that so many clinical trials results are not adequately reported in the Netherlands.”
Vidal called on action to be taken at all levels to improve the situation:
“We urge public and private sponsors, as well as the research community and relevant authorities, to comply with European Union regulations and World Health Organization guidelines, in place, above all else, to ensure patient safety.”
Report author and TranspariMED founder, Dr Till Bruckner, added:
“Clinical trials can cost millions of Euros to run, while uploading their results only takes a couple of days. Other European countries have clearly demonstrated that this problem can be solved at low cost. Dutch patients and taxpayers deserve more respect.”
In October last year, HAI and TranspariMED organised an event at the European Parliament to highlight to importance of clinical trials transparency, laying out the recommendations from our joint 2019 publication Clinical Trials in the European Union: A Roadmap to Greater Transparency. While a number of our recommendations are being taken forward by the European Medicines Agency, it is clear there is a long way to go before all trials sponsors across the EU live up to their obligations.
Read the full report: Clinical Trial Transparency in the Netherlands: Mapping Unreported Drug Trials
[An earlier version of this report incorrectly identified the Medicines Evaluation Board (CBG) as the institution responsible for keeping track of clinical trials being conducted in the Netherlands. This is not the case – it is not part of the CBG mandate to record or follow up on clinical trials].