BLOG: Making clinical trials public - transparency, openness and our latest audit of registration

Last updated on 17 Mar 2024

The Health Research Authority’s vision is to make it easy to do research that people can trust.

Trust is hard to earn but easy to lose. It means different things to all of us. But we know, because we asked you about it, that when it comes to health and social care research, trust is rooted in transparency. In a survey of more than 5000 people last year, we heard that two thirds would feel more confident in health and social care research if the project was added to a public register before it started, or if the results were made publicly available as soon as possible after the study.

Transparency is one of our statutory responsibilities. Back in 2018 we were asked by the House of Commons Science and Technology Committee to make it easier for researchers to understand what they need to do to make sure trusted information about health and social care research is publicly available for the benefit of everyone. And Make it Public was born!

Since then we’ve made significant progress against the commitments in our research transparency strategy. We’ve partnered with ISRCTN to automatically register clinical trials of medicine submitted through combined review, we’ve introduced a new form for final reports at the end of a study, and we’ve updated our website to make it easier to understand transparency actions needed at each point of a research project.

The requirement for clinical trials to register on a publicly accessible database at the latest six weeks after the first participant is recruited has been a condition of favourable Research Ethics Committee opinion since September 2013.

From 2015 we’ve reported on the proportion of trials which have met this requirement. You can read those audits on the transparency section of our website.

When we ran a consultation in 2019 to ask you how the HRA should prioritise resource to improve research transparency, almost 7 out of 10 people (69%)* felt that we should publish a more detailed audit of clinical trial registration, with a list of which trials are registered and which are not.

In the future, the systems that we use to manage applications to the HRA will help make this easy. Our existing systems are aging and don’t make it as smooth as it could be, but this week for the first time we’re able to publish a line-by-line list of all clinical trials reviewed and given a favourable opinion by a Research Ethics Committee (REC) in 2022 and whether we have a record of their registration.

To make sure that our data is as robust as it can be, in the last few months we have contacted all of the study teams for which we have no record of registration. Twice if we received no reply the first time. In the future, this will be managed through automatic reminders.

Today we’re publishing the data as tables by month in which they were given a favourable opinion by a REC.  The audit is intended to be a snapshot of a point in time, the records we hold today. It might be that trials without a registration record today do go on to be registered in a publicly accessible database in the future, after we have published our data.

We are not publishing this data in isolation. Later this week we’re welcoming hundreds of researchers, sponsors and funders to an interactive workshop on improving research transparency. This will inform our future work. We’ll talk about the barriers to transparency and how we can make it easier to make sure all studies are registered. Look out for more on our social media channels X and LinkedIn.

Our audits of clinical trial registration, including this year’s study by study version, show that we are making progress, but participants deserve, and trust relies on, 100%, and our goal remains to Make it Public.

*question 8 in our consultation

Naho Yamazaki, Head of Policy and Engagement

Naho Yamazaki

Deputy Director of Policy and Partnerships
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