Over 4,000 drug trials in Europe are still missing results. Here’s a plan for getting them reported.

This month marks a milestone for clinical trial transparency in Europe. For the first time, the results of more than two thirds of drug trials are now publicly available on the European trial registry.

On the flipside, nearly a third of all drug trials – 4,223 trials in total, including hundreds of trials involving children – are still missing results.

Remember: Every unreported drug trial leaves a gap in the evidence on the safety and effectiveness of a medicine, potentially exposing patients to suboptimal treatments and unknown risks. In addition, every unreported trial is a waste of money, because invisible trial results make no contribution to advancing science or improving health care.

So we’ve come a long way, but there is still some distance to go.

Here’s a quick overview of progress to date, and a rough plan for how we – as a community – can get those 4,223 hidden trial results made public.

When did it all start?

There is an ongoing a trend in Europe towards more transparency in clinical trials. Most large pharmaceutical companies cleaned up their act years ago, but universities, hospitals and smaller companies for a long time did not even realise that they had a problem.

That changed in 2018, when the EU Trials Tracker showed just how badly universities in particular were doing. Some of Europe’s top medical universities had run hundreds of trials, but made virtually none of their results public, in violation of EU transparency rules.

Armed with the new data, TranspariMED and numerous other groups across Europe started campaigning for universities to fix the problem.

Why did it take so long?

Universities initially told us that they found it nearly impossible to upload results onto the European trial registry. So first, we had to convince the European Medicines Agency to make the system more user friendly – which it did. Soon after, the BIH QUEST Center produced a clinical trial reporting manual that gave universities step-by-step guidance on how to fix the problem.

However, many universities still argued that uploading trial results was not necessary, too much work, or not a priority. So our loose coalition had to create some momentum. Through reports, blogs, Tweets, and direct engagement, we kept highlighting the problem.

Generating mainstream media coverage was crucial to success. Whenever politicians and the public became aware of the problem, they told universities that they expected them to follow the rules. Every time a newspaper ran a big story on unreported trials, universities in that country started to upload missing results – first in the UK and Ireland, then in Germany and Austria, and most recently in the Netherlands. (Coming next: Belgium…)

How can we get those hidden trial results reported?

TranspariMED will work closely with allied groups to ensure that the remaining 4,223 hidden clinical trial results are made public. Here’s how.

• Universities in front-runner countries

Most universities in the UK, Ireland, Germany, Austria and Denmark are now moving in the right direction. Some have already achieved reporting rates of 100%. Dutch universities are currently starting out on the same journey.

In front-runner countries, TranspariMED will produce follow-up blogs and reports to monitor progress, keep up the momentum, and make sure that no major institution gets left behind.

• Universities in lagging countries

Most universities in Belgium, Italy, Spain, France, Sweden and Norway still perform extremely badly. The situation is worst in France and Norway, where not a single institution seems to be tackling the problem.

To get things going in these countries, TranspariMED will replicate its tried-and-tested approach: partner with national groups, produce a report highlighting the problem, and attempt to secure front-page coverage in a national newspaper.

(Note: we are still looking for partners in Sweden and Norway, so if you work there, please get in touch.)

• National medicines regulators

Frankly, many national regulators have dropped the ball on this in the past, leaving problems to pile up. Now, some regulators argue that they are powerless to do anything because they cannot (yet) legally force universities to upload missing results. This is misguided. Regulators in some countries have successfully driven improvements by reminding companies and universities of their obligations and supporting their compliance efforts. Other regulators have worked hard to improve data quality on the European registry. Stronger regulator engagement is essential to getting the results of all trials made public.

TranspariMED will encourage national regulators across Europe to become far more proactive, and to start imposing sanctions on law-breaking companies and universities as soon as the EU Clinical Trial Regulation fully comes into force in late 2021.

TranspariMED will also encourage European regulators to follow the UK's example and set up comprehensive national systems that ensure that 100% of all clinical trials - not only drug trials - are registered and make their results public.

• Research funding agencies

Surprisingly, many public research funders in European countries still hand out money for clinical trials without subsequently checking whether the results of those trials are made public. This means that tax money is being wasted on expensive trials that neither contribute to scientific progress nor improve patient care.

TranspariMED will continue to challenge funding agencies across Europe to commit to WHO transparency standards and monitor whether their grantees make trial results public.

• European Medicines Agency

In the past, EMA has positively responded to our advocacy by making trial reporting easier through streamlined processes, new training materials, and setting up a helpdesk. We will continue this constructive dialogue.

TranspariMED will urge EMA to fix a technical bug in its registry that continues to make life difficult for universities, and will closely monitor the launch of the new Clinical Trial Information System (CTIS) in 2021.

If you or your organisation want to get involved in any of the work outlined above, please get in touch.