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Our analysis of public involvement in clinical trials

Last updated on 21 Mar 2023

During last year’s consultation on the future of UK clinical trials legislation, we worked to understand the current level of public involvement in clinical trials.

We use the phrase public involvement to mean researchers working in partnership with patients and the public in the design and conduct of research to get the best results - in this case clinical trials. It does not mean directly taking part in a trial.

To do our analysis, we looked at all applications to conduct clinical trials of medicines, known as CTIMPs (Clinical Trials of Investigational Medicinal Products), which were made to the HRA over a six-month period. Applications came from commercial sponsors such as pharmaceutical companies, and non-commercial sponsors, for example a university or health charity.

What did we find?

There were 479 applications in total. 46% of all CTIMPs said they had involved the public in their research.

We compared these to an equivalent sample of applications for other types of health and social care research over the same period.

We found that these non-CTIMP research teams said they had involved the public in 84% of studies. Public involvement in CTIMPs is lower than in other types of health and social care research.

What does this mean?

Our snapshot looked at a small number of studies over a short period of time, but clearly showed that clinical trials have much less public involvement than other types of research.

We’ll be producing a more detailed analysis in the coming weeks, to help inform our work with the Medicines and Healthcare products Regulatory Agency (MHRA) and the research community to develop new guidance that will support research teams to involve patients and the public meaningfully in all research.

Dr Janet Messer, Director of Approvals at the HRA said:
"We understand how the public is involved will look different for each research project and will work with those involved in research, and the public, to develop guidance to support researchers to do this well and help Research Ethics Committees with their review, making meaningful public involvement the norm."

If you’d like to be kept informed about this work, and have the chance to get involved, you can let us know by filling in this short form.

Further information

Based on an analysis of applications to UK Research Ethics Committees to conduct health and social care research from September 2021 to February 2022. We analysed responses to question A14-1 on the IRAS form - “In which aspects of the research process have you actively involved, or will you involve, patients, service users, and/or their carers, or members of the public?”

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