Published: 24 November 2020
Shaun Treweek, Ella Anderson, Adepeju Oshisanya and Miles Witham write about the problem of trials that do not represent the communities they are meant to serve. Here they explain how the NIHR INCLUDE initiative aims to change this.
Why do we do trials? You might think the answer is obvious, but it is worth taking the time to delve a little deeper. Those of us working in trials want them to help change lives for the better. We want to improve the health of people who have a health condition and who may be looking for solutions. A cure would be best, but failing that, something which reduces the impact that the health condition has on everyday life.
But who, exactly, are the people we want to help? Trial protocols list eligibility criteria so surely that’s ‘job done’. But is it? Have a look at the list of eligibility criteria in any study protocol and ask this question –
How sure are we that these criteria, and our trial processes, allow all those in the community who could potentially benefit to a) take part in our trial and b) remain engaged?
Under-serving our communities
It is entirely possible to run a trial that includes people who meet the eligibility criteria, but at the same time has a participant population that looks very different to the people in the community who have the health condition specifically targeted by the trial. Such a trial, whilst able to meet its own objectives, will fail many of those in the community who should be benefiting from it.
It is not difficult to find examples. COVID-19 is shining a very bright, and very harsh, light on our failure to serve whole communities with regard to minority ethnic groups, who are more likely to suffer severe illness and death from COVID-19 in the UK. Work published in June 2020 found that of 1,518 COVID-19 studies registered on ClinicalTrials.gov, only six studies were collecting data on ethnicity. This is despite the role of ethnicity becoming apparent very early on in the pandemic. However, the problem did not start with COVID-19: where data exist from previous trials (for instance cancer trials or type 2 diabetes), people from minority ethnic groups are included at rates far lower than we would expect, given their share of the population and the disease burden.
In other words, considering ethnicity in trial design and removing barriers that can hinder trial participation is not routine. This can be extended to other under-served groups, such as older people, people with low incomes, people with cognitive disabilities, LGBTQ+ groups, people with hearing impairments. The list goes on.
The INCLUDE Roadmap
This is what makes NIHR’s INCLUDE initiative, the roadmap for which was recently published, so important. Initiated in 2017, INCLUDE has run scoping reviews, surveys and stakeholder events to produce a roadmap to steer development of guidance and initiatives to increase the inclusion of under-served groups in research.
INCLUDE is a fantastic initiative because the link to NIHR – the UK’s largest funder of health and care research – means there is real potential for change. As any researcher knows, where funders lead, we follow. Not only that, where NIHR leads, other funders follow: the Wellcome Trust has already updated its clinical trials policy to highlight under-served groups and the INCLUDE guidance. NIHR is serious about tackling health inequalities, including improving inclusion in the research it funds. INCLUDE guidance gives pointers to guide the deliberations of funders, researchers and delivery teams as they design and assess clinical research proposals. It gives examples of good practice too.
On the INCLUDE site there are also additional resources that provide useful information on ethnicity in clinical trials, developed together with public and patient partners, Trial Forge, the Medical Research Council-NIHR Trial Methodology Research Partnership, the Health Research Board Trial Methodology Research Network and the Centre for BME Health. Former Director of the NIHR Health Technology Assessment (HTA) Programme, Hywel Williams, highlighted initiatives aimed at increasing involvement of people from minority ethnic backgrounds in his July 2020 Director’s message.
INCLUDE’s work is ongoing. It will engage with funders and regulators to ensure that representation of under-served groups is taken into account in funding decisions, regulatory approvals, policies and, crucially, will work to ensure that sufficient resources are made available to implement our guidance.
Trials that do not represent those in the community who could benefit are failed trials
If a trial does not represent those in the community who could benefit, then it is a failed trial. The INCLUDE initiative provides both a structure and a catalyst to improve study design and delivery and get more people from under-served groups into clinical research. By making trial evidence more applicable, we think INCLUDE will lead to better healthcare for people from historically under-served and marginalised groups.
Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who they are.
Ella Anderson (NIHR INCLUDE Project Coordinator), Shaun Treweek (Professor of Health Services Research), Adepeju Oshisanya (Clinical Development Operations Leader), Miles Witham (Professor of Trials for Older People).
- The full paper on the INCLUDE Roadmap can be found in Trials, or the Roadmap is summarised on the NIHR Evidence website
- More information about INCLUDE can be found on the INCLUDE project website
- More information on projects funded by the NIHR and UK Research and Innovation to improve our understanding of the links between COVID-19 and ethnicity
- NIHR Guidance from the INCLUDE project: