Last week, German and UK experts jointly explored policy options for ending research waste in clinical trials in Germany. This blog provides some highlights of the debate.
The video of the full event is now available on YouTube.
The full transcript (both in German and in English) can be downloaded further below.
“If the time is not now, when then? We have a health minister who comes from a medical research background. He is a medical doctor. He has some experience in evidence based medicine.”
- Stefan Sauerland, DnEBM
Across Europe, clinical trials fall into three distinct regulatory categories: investigative drug trials (CTIMPs), medical device trials, and all other trials. For drug trials, there is now a legal requirement to make results public, and compliance rates are high. For device trials, legal requirements are on the horizon, but future compliance remains a major concern. For all other clinical trials, there is no legal obligation to make results public.
In Germany, between a quarter and a third of device and ‘other’ trials never make their results public – a huge amount of costly research waste that leaves potentially dangerous gaps in the medical evidence base.
How the UK system works
In the UK, ethics approval documentation is centrally archived by the Health Research Authority. The Health Research Authority itself registers new clinical trials on the global ISRCTN registry, and one year after trial completion checks up whether the trial’s results were made public.
What can we learn from the UK experience?
How did the UK system get started, how was it designed, and what challenges remain?
Martin Smith, ex UK House of Commons
Martin Smith worked at the House of Commons Science and Technology Committee in 2018 when campaigners prompted the committee to focus on clinical trial transparency. He noted that the establishment of the Health Research Authority (HRA) in 2014 “created an obvious owner for this problem” as it had been tasked with improving medical research transparency.
“I think having spent a number of years working with Members of Parliament, I say there's a couple of things that really attract their attention. One is the scope for calling out strongly something that is fundamentally explainable in a clear, really clear way. The second is the scope for them doing that, actually creating a change as a result. Both of those things are attractive, being on the right side of history, but also being able to actually make a difference.”
“Clinical trials transparency seemed like a fixable problem, but what was needed was the political will to really push it over the edge.”
“It wasn't actually that expensive in the grand scheme of things, particularly given the scope and the importance of this issue.”
Naho Yamasaki, UK Health Research Authority
The Health Research Authority (HRA) was created 11 years ago to provide a UK wide coordinated service for research ethics review. The HRA supports the UK’s 60 research ethics committees, and also has a statutory responsibility to promote research transparency.
“What we did first was to establish an advisory group to develop a draft strategy. We then set about consulting on that strategy, because what we wanted was something that is ambitious, that takes us to the vision of full transparency across the system, but through means that are meaningful and manageable and that have the buy-in of the entire sector.”
“We talked to many members of the public and when people found out that the results are not routinely shared with participants, people really were quite shocked.”
“Researchers told us that transparency requirements aren't always clear, so one of the first things we did was to clarify requirements. We also produced a standard set of data that people need to submit to us through this final report.”
Marc Taylor, ex ISRCTN registry
“A lot of the elements in the UK strategy actually date from a long way back. The importance of the national #MakeItPublic strategy is that it really does a good job of drawing things together, and of giving the HRA the remit to show leadership in this area.”
“The big change comes when sponsors are insisting on transparency and setting up internal systems and employing research managers to help their researchers to deal with the challenge. But it takes a long time to set up a network of research managers. Many institutions in the UK still offer very weak, inconsistent support to their research management and for their research teams.”
“I think we made a mistake when we were introducing the partnership between the HRA and the ISRCTN. Before launching that, we should have spent much longer talking to data managers in industry and the universities and funders about the mechanics of lifting data easily from one system to another, and aligning the processes and the definitions.”
How can we get this to work in Germany?
Matthias Perleth, HTA Verein
“One good example that transparency is possible and that mandatory registration could become a reality in Germany is a trauma and implant registry that will start up in 2025.”
“I think what we would need is a national alliance in Germany. We would need people from the German parliament, members of parliament, from the Ministry of Health, from research, funders and sponsors, and from medical universities. However, what makes it more difficult, is that we do not have a German Health Research Authority or an equivalent of that.”
Daniel Strech, QUEST
“The policy adjustment would have to be that German research ethics committees that not only approve drug trials [CTIMPs], but all other interventional trials too, they need to have a process for informing a centralized body about the approved trials. And we don't have this yet.”
“It's very important to make use of all the software and code that allow us to get information from registries and about results reporting in a more automated way.”
“All of this, in principle, should not be something like rocket science. It would be possible in principle. But the ethics committees alone cannot implement this. They need to work together with some people who have political will and political decision power.”
Stefan Sauerland, German EBM Network
“I think the main role here would be for [national drugs regulator] BfArM, because they already have all these trials on drugs, they have many of the trials on devices. And if we could convince the local ethics committees that they send all their trials that fall in the third ‘other’ category of trials to BfArM, the regulator could keep a record of all trials. And this would then create a monitoring list of all German assets.”
“BfArM would be required to send out reminders to all responsible, and they would at least require updating the study registration once a year. And of course, if the study has reached the end of the recruitment period one year ago, BfArM would require reporting of results in any way.”
“The main problem would be that we need some resources, maybe at the ethics committees, but mainly at BfArM.”
Flowchart source: Stefan Sauerland, DnEBM
Christoph Stein, Transparency International Germany board member
“Why is Germany the target of this panel today and not the EU? Instead of targeting Germany as the only country here, we should target the entire EU. There is a big platform at the EU and it's pretty rigorous and it's working pretty well in my own experience.”
“Speaking as an active researcher, from what I've experienced, the political will is there and we have just heard all the possibilities that were laid out very clearly. I think Germany would be ready to implement a lot of the same rules that were implemented in the UK.”
Download the full transcript
The full transcript of the debate can downloaded below in German and English language.
The video of the event is available on YouTube.