Martin O’Kane
Deputy Director, Clinical Investigations and Trials, MHRA
Jim Elliott
Public Involvement Lead, HRA
Clinical research shouldn’t just be shaped by the researchers conducting it – the voices of patients, carers and other members of the public are vital.
A variety of voices involved in clinical research makes the clinical trial experience a better one for all, with richer results, drawing on patients’ experience and knowledge of what is being investigated.
Greater public and patient involvement
Despite this, current clinical trials legislation is silent on patient and public involvement. So, this year, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have taken big steps to try to change this.
In January, the MHRA launched a public consultation in which we proposed ways to promote public involvement in clinical trials. For example, by introducing a legal requirement for the involvement of people with relevant and appropriate lived experience in the design and conduct of trials.
Reaching under-represented groups
Greater public involvement will facilitate the inclusion of under-represented populations, for example pregnant and breastfeeding women and other under-served communities. Working with patients, the public and the scientific community, we have an ambition to make trials as safe and as accessible as possible.
That’s why our consultation includes a range of proposals that will benefit patients, such as improving transparency by introducing a requirement to publish a summary of results within 12 months of the end of the trial and to share that with participants in a suitable format.
Through the proposals outlined in this consultation, the results of which will be published later this year, we aim to make the UK one of the best places in the world to conduct robust, safe clinical research.
We agreed to listen and learn from the people and communities we involve, support improvements in equality, diversity and inclusion in public involvement.
Improving extent and quality of involvement
In March, the HRA and MHRA – alongside a number of other organisations – signed up to a shared commitment to improve the extent and quality of public involvement in research. Working together, we pledged to support the research community to carry out excellent public involvement by sharing guidance, policies, systems and incentives.
We agreed to listen and learn from the people and communities we involve, support improvements in equality, diversity and inclusion in public involvement as well as to embed this commitment into our own organisations’ decision-making processes.
Having left the EU and learning from our positive response to COVID-19, partners from across the UK research system are continuing to work together to make the UK one of the most attractive places in the world to conduct efficient and cutting-edge clinical research by putting patients and their voices at the heart of decision-making.