Naho Yamazaki, Deputy Director of Policy and Partnerships
I was once talking to a regulator who said that a medicine that’s only been tested in Japan would not be licensed here. Being from Japan and knowing how its population doesn’t have the ethnic diversity you see in the UK, I thought that makes sense. But it also made me wonder how we are making sure that medicines and devices are safe and effective for all the people who use them in each country.
We know that people may respond differently to an intervention because of differences in genetic, social, cultural or other factors. Because of this, it’s important that research includes a wide range of participants. Otherwise, results may not be applicable to the whole population affected by the disease. And we may not find out whether the balance of benefit and risk of an intervention is different for different groups of people. We need representative and diverse research participants if we want research to benefit everyone, and if we do not want to reinforce existing inequalities.
Clinical trials, however, often enrol populations that do not represent the full range of people who require evidence about the intervention. Women are disproportionately underrepresented in trials relative to the burden of disease despite increased awareness. The same is true for ethnic minorities, which led the US Food and Drug Administration (FDA) to issue guidance to address this last year. The Chief Medical Officer’s annual report 2023: health in an ageing society points out how trials often exclude older adults or those living with comorbidity or multi-morbidity.
We at the Health Research Authority want to change this.
One of the things we are doing towards this change, with the Medicines and Healthcare products Regulatory Agency (MHRA), is developing guidance for researchers to help them to improve the diversity of participants in their research. The aim is to ensure clinical research is designed to include people who could benefit from the findings, and that people underserved by research are not overlooked. It will also help increase the diversity of patients recruited, as recommended by the Lord O’Shaughnessy review into commercial clinical trials, and make the UK an even more attractive place to do clinical research.
We’ve already had a lot of engagement with people in the research sector in developing this guidance, including those from academia, NHS, industry, research funders, and Research Ethics Committees, as well as members of the public. I have been overwhelmed by how supportive people are to drive forward change, so that we get evidence for all the people who could benefit from what the trial is investigating.
And it is great to see that support also comes from the wider UK population, based on findings from the recent public attitude survey we commissioned from YouGov. It clearly showed that people think a diverse mix of participants in health and social care research is important, even if the research costs more money or takes more time.
We are busy finalising the guidance with the MHRA and hope to publish the draft for comments in early 2024. So more to follow.