Ahead of speaking at the 10th Annual Outsourcing In Clinical Trials UK And Ireland Conference 2023, Neelam Patel, Non-Executive Director at the Health Research Authority, shares her thoughts and experience of the importance of diversity in good research
Non-Executive Director, Health Research Authority
I recently joined my local gym in a bid to keep fit and take better care of myself. Outside the gym was an NHS Health Check van offering quick checks that are designed to spot the early signs of stroke, heart attack and type 2 diabetes.
In the spirit of looking after myself I thought I’d better get a check just to make sure everything is okay and queued up. They did a finger prick blood test, checked my blood pressure and took my height and weight to calculate my BMI. Just a formality I thought – I'll have no issues...
...not quite. When talking through my results I was shocked to find out that I was borderline for early signs of diabetes.
The nurse explained that due to research from tests like this there is data that shows that people from an Asian background are at an increased risk of diabetes and therefore the normal ranges for BMI for people from an Asian background are lower than for other ethnicities. The interesting thing was that the check was being done outside the gym, typically where people go to get fit, perhaps where there would be more engagement. I wonder how many people would sign up for a health check anywhere else?
It struck me that without realising I had demonstrated the very thing the Health Research Authority champions – the importance of diversity in research.
Why is diversity important and what does it mean in action
Why is diversity so important? You’ll see lots written about it, but what does it mean in action?
If we go back to my health check, if the only results we received were from people from one narrow group of people, how would we have identified that people from an Asian background are at an increased risk of diabetes? How would we identify the early warning sign markers? And most importantly, how would we prevent thousands of people every year from developing diabetes.
The answer is simple. A diverse range of participants in research gives better results that help the health and wellbeing of all communities. Data from a diverse pool of participants means we can build a more accurate picture of a population’s needs.
Diversity in research a key priority for the Health Research Authority, outlined in the ‘include’ pillar of our strategy and something that was clearly identified in Lord O’Shaughnessy’s recent review into commercial clinical trials in the UK.
Lord O'Shaughnessy Review
'It is essential that clinical trials in the UK reflect our diverse population to provide benefits to all patients…the population diversity of the UK offers the potential for companies to demonstrate the effectiveness of products across a wide range of patient populations.'
I know from personal experience that ensuring a study has a diverse range of participants isn’t easy. There’s lots of factors to think about.
That’s why the HRA and MHRA are working together to develop guidance to support researchers to increase the diversity of people taking part in research.
The new guidance will help make it easier to understand the requirements around diversity and what little changes we can all make, that will make a big difference.
The finger prick test I had to measure my blood glucose on the face of it is a straight forward thing to do. But would it work if we were carrying out health checks during Ramadan when Muslim communities are fasting during daylight hours? Are these interventions culturally acceptable during the Holy Month of Ramadan? What impact would that have on the results gathered? Would it skew the data and potentially mean we miss out on vital clues?
When we talk about diversity it’s not just about ethnicity either. From my previous experience in the pharmaceutical industry I often came across examples of paediatric studies trying to recruit during school times and not factoring in when terms start or begin. It had a huge impact on recruitment, and the potential to narrow the diversity of our patient pool.
Studies have to be designed with people in mind
These things matter. Studies have to be designed with people in mind. They have to be culturally sensitive. Without that how can we earn the trust of potential participants who are trusting us with their information, time and health.
At the HRA I’m really keen for us to lead the way on this work. We’ve recently established a new community committee, who will help us listen to and involve a diverse group of people in our work. We’re also working to increase the diversity of our Research Ethics Committee members to ensure that those range of voices are heard when studies are being ethically reviewed.
In the coming months we will be launching some new hallmarks of ‘people-centred clinical research’ which will make it clear that research and researchers should be representative and fair throughout their practice, not just in the study design.
On Tuesday 5 September I will be co-presenting a session at the 10th Annual Outsourcing in Clinical Trials UK and Ireland Conference alongside Dr Suki Balendra.
The session is titled ‘Diversity in Finding New Medicines’ where we’ll be talking about the importance of diversity and looking at examples of how this is being approached in the US by the FDA.
You can read more about practical steps you can take to increase the diversity of people taking part in your research I’d encourage you to head over to the Health Research Authority website and take a look at the guidance on there.
If you spot an NHS Health Check van in your area please do take the opportunity to get a quick check.