This failure to publish trial results endangers patients, contributes to exploding drug costs, and slows down the discovery of new treatments and cures.
What can advocacy and patient groups in Europe do to drive better trial reporting?
Across Europe, universities in particular are failing to follow European Union guidelines and WHO best practices. 89% of university trials have not posted results onto the European trial registry. Many of these trials have not reported their results anywhere else, generating a huge amount of costly research waste. For example, German universities have left up to 53% of their trials completely unreported - a clear breach of medical research ethics.
Only one country performs comparatively well: Great Britain.
While many trials remain unreported, several British universities already have high reporting rates on one registry. Many others are planning to tackle the problem in the near future. Parliament has recently called on the government to launch a “national audit programme of clinical trials transparency” and impose sanctions on institutions and individuals who fail to register trials or report their results, accelerating this momentum towards reform..
What can advocacy and patient groups in Europe learn from the British example?
Below are three simple steps advocacy and patient groups in Europe can take.
1 Talk publicly about this problem, and how it can be fixed
It is not a coincidence that the debate around hidden clinical trials is far more advanced in the UK than in other European countries. Dr Ben Goldacre, a campaigning doctor, has worked tirelessly for years to bring the issue to the attention of British policy makers and the public.
Thanks to his efforts, research funders, universities, and even companies based in the UK routinely top global transparency rankings. In addition, we now know how to fix this problem: we need effective national monitoring plus real sanctions.
2 Ask politicians to stop the waste of public money
Policy makers are extremely busy and may struggle to understand how missing clinical trials affect systematic reviews and meta-analyses, and why that matters. Ethical arguments too can fail to resonate. In contrast, when you point out that public money is being spent on medical research that does not report results, and that this money is being completely wasted, policy makers start to listen.
Requiring all clinical trials to post their results onto all registries where they are listed within 12 months is a common-sense solution that can improve public health at virtually no cost – an attractive message for political leaders.
3 Challenge public institutions to curb research waste
National laws should require all trial sponsors to post their results. However, new laws can take a long time to draft, adopt and enforce. In the meantime, strong impact can also be achieved by insisting that medical research funders ensure that all clinical trials supported by tax money post their results onto registries within 12 months.
For example, most public research funders in European countries have not yet signed up to WHO best practices in clinical trial transparency. They should be encouraged to immediately do so.
Equally, universities and public institutions should be publicly challenged on their trial reporting performance and be encouraged to fix the problem. The EU Trials Tracker and a transparency tool for the American trial registry make it easy to discover who is posting their trial results – and who is not.
It is high time for advocacy and patient groups across Europe to speak up and demand that politicians, funding agencies and other public institutions take action to finally resolve this important problem.
Note: TranspariMED is available to help advocacy groups develop project proposals or advocacy strategies to drive better trial reporting performance in their own countries. Sections of this post were first published on the PEAH – Policies for Equitable Access to Health blog.