Inclusion of under served groups in trials

An audit at a UK primary care clinical trials unit

Rebekah Burrow is leading this research.

While working with a colleague, Melanie Carr, on how to find more data for a clinical trial, we discovered a shared interest in inclusive clinical trials.

What is the problem?

“Under-served groups” are groups of people for whom the research and healthcare communities need to provide a better service. Often people in under-served groups are excluded from research. At the same time, people in under-served groups often need more, or different, healthcare. A few examples of under-served groups include people:

• under 18 years old
• of minority ethnic groups
• with less access to financial, educational, social, and health resources (“low socio-economic status”)

Clinical trials are a type of research. Clinical trials need to study people (participants) who are representative of real patients. When they do, we can work out how safe and effective the interventions (maybe a medicine or a test) being trialled are, for real patients. Different groups of people (for example, men and women) sometimes respond differently to interventions. If doctors do not know how well an intervention works for an under-served group (for example, pregnant women and people) they may not offer it to them. People in under-served groups sometimes get more ill than they need to because of this.

Public organisations in the UK who spend money on research tell researchers to make their research inclusive of under-served groups. It is also an ethical principal that clinical trialists (researchers who carry out clinical trials) promise to uphold.

However, we do not know much about how inclusive clinical trials are. We also do not know much about how representative the participants are.

What research did we do?

This research is an audit. An audit is an independent examination of what has happened. This audit measures how inclusive trials are, in the Primary Care Clinical Trials Unit. Lucy Goddard joined the team to help us do this work. This is a Clinical Trials Unit at the University of Oxford, in the Department of Primary Care Health Sciences. There are about 50 Clinical Trial Units in universities and NHS organisations in the UK. In the audit we looked at whether:

• researchers deliberately excluded under-served groups
• researchers told potential participants who was allowed to take part
• researchers collected data on under-served groups that could take part

What did we find out?

We audited 19 clinical trials. The clinical trials looked at lots of different health conditions, including COVID-19, diabetes, urinary tract infections, and high blood pressure. The clinical trials were trialling interventions like medicines and tests.

All the clinical trials excluded some under-served groups. Trials often excluded people because of their:

• age
• sex or gender
• spoken language (which almost always had to be English)
• capacity to consent for themselves (sometimes if someone is too ill to understand what the trial is, or decide to take part (or not), a family member can consent for them)
• pregnancy
• being too ill for the trial (for example, their COVID-19 was too severe to join a trial of a COVID-19 treatment)
• having too many different illnesses (for example, having a mental health condition as well as the illness important for the trial)

About half the time researchers told potential participants who was allowed to take part in “patient information leaflets”. Researchers were most likely to tell potential participants about what age and sex of people were allowed to take part.

Researchers often collected data about some under-served groups that could take part. These included participants’:

• age
• sex
• ethnicity

Researchers very rarely collected data about most under-served groups that could take part, including participants:

• socio-economic status
• disabilities
• pregnancy

What does this mean?

Many clinical trials were designed to carry out research to look after one under-served group (for example, people over 75 years old). Often this meant they had to exclude other under-served groups (for example, pregnant women and people). Some trials made special efforts to include other under-served groups (for example, by explaining the clinical trial to very ill patients using simple words and pictures).

Some clinical trials excluded under-served groups when researchers could have found a way to include them (for example, people who do not speak English fluently).

These unnecessary exclusions are likely to have made some trial participants less representative of real patients.

All trials could have collected more useful data so they knew how much their participants represented real patients.

What are we doing about it?

The Institute for Cancer Research Clinical Trials and Statistics Unit have already carried out a very similar audit.

We have also:

• told the Primary Care Clinical Trials Unit about their results.
• published our work for other researchers to read
• asked other Clinical Trial Units to carry out the audit - so eight have started or completed the work
• set up a team in our department to focus on making our research more inclusive
• decided which under-served groups we are going to do better for, first
• started working out how to collect more useful data
• invited other CTUs to look at our results together to see what patterns we can find, and what we can learn from each other

We will ask for funding to carry out the audit again together in a few years’ time, to see what has changed, and what hasn’t, how we can improve clinical trials and what we know about them.