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Statement in response to ‘Failing to publish data from clinical trials presents risk to human health’ (Science and Technology Select Committee)

Last updated on 29 Oct 2018

The Health Research Authority (HRA) welcomes the report published today by the House of Commons Science and Technology Committee as part of its inquiry on Research Integrity, and the recommendations within it.

One of the key principles in our UK Policy Framework for Health and Social Care Research is that ‘research is designed, reviewed, managed and undertaken in a way that ensures integrity, quality and transparency’. We agree with the committee that clinical trials transparency is a vital component for trustworthy science, and essential if we are to ‘protect and promote the interests of patients and the public’.  We are committed to enhancing our work in this area.

Having reflected on the evidence submitted to the committee by ourselves and others earlier this year, we have already begun to take action on some of the areas raised in today’s report.

Our 2016 audit of clinical trials registration showed that whilst compliance rates are improving, researchers and their sponsors still have further to go. As our chair, Professor Jonathan Montgomery, suggested in his written evidence to the committee, the audit showed that engaging with the research community increases the registration rate, by addressing a lack of awareness of basic requirements. We have carried out a survey to explore this issue in more depth and the details will be published next month. One emerging finding is that awareness of end-to-end transparency requirements is patchy and, even where knowledge is good, subsequent behaviour does not always deliver against researchers’ obligations.

We had hoped to increase compliance with research transparency requirements by making those requirements clearer, working with funders to align expectations of researchers and introducing automated reminders at the relevant stage of a study in order to make compliance as easy as possible. We’re confident that these measures will have an effect, but it’s not clear that this will be sufficient to deliver the benefits that we want to see. To truly drive innovation and reduce research waste, the HRA will now look how we could take a more robust approach, including potential sanctions, for example not providing ethical approval to new studies until existing ones have been registered in line with the current guidance.

We welcome the recommendation in today’s report that our current transparency work be brought together into a formal and detailed strategy during the coming year, and will consult with others in the research community before it is finalised. We also welcome a discussion with the Department of Health and Social Care to explore the financial and statutory implications of the HRA taking on a more robust role in ensuring complete reporting and transparency if all of the select committee’s recommendations are taken forward.

We are committed to do more to drive research transparency, which is both a good practice requirement and long-standing ethical principle. Transparency is essential so that participants are protected from unnecessary research and patients benefit from improved outcomes and care informed by high quality studies. We will act on the recommendations published by the select committee today, and report on our progress.

 

Teresa Allen, Chief Executive

Professor Jonathan Montgomery, Chair

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