Researchers must do more to include older people in clinical trials if we are to improve outcomes for patients, according to one of the NIHR Newcastle BRC’s lead researchers.

Professor Miles Witham, the NIHR Newcastle BRC co-theme lead for ageing, sarcopenia and multimorbidity, and Professor of Trials for Older People at Newcastle University, gave a talk to members of the public at Brunswick Methodist Church where he outlined why it is so important for older people to be included in clinical trials to ensure they benefit from effective treatments.

Miles said:

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“This talk was a great opportunity to engage with the public about research and cover why older people are excluded from research trials, why this matters, and what we can do to make things better."

“Older people are a group that get ill more than others. They are also most likely to be affected by health conditions and to use the NHS - yet they are often excluded from the clinical trials that tell us whether treatments are effective.

“We can make trials better for older people but it requires time and effort, as well as listening to what older people tell us. Most importantly, it requires a flexible approach – older people are not all the same and how we offer our trials needs to reflect the needs of a broad range of older people.

“Older people do want to take part in research but we need to remove barriers to their participation, test interventions that are relevant to older people’s health, and measure outcomes that are important to older people.

“The NIHR Newcastle BRC recognises that there are multiple groups who are under-served by current research. Older people and those living with frailty are two of those groups. We’re making efforts to improve inclusion of these under-served groups and ensure that older people can help us find treatments for and prevention of the conditions that affect them most.”

Case study – MET-PREVENT

The ground-breaking MET-PREVENT trial is one of the first to determine whether the drug metformin, commonly used to treat diabetes, can improve physical function in older people living with frailty.

This clinical trial recruited 72 people from Newcastle and Gateshead – these were people who were over 65 years old, with muscle weakness as shown by a slow walking speed and reduced hand or leg strength. This group do not find it easy to take part in clinical trials, and so MET-PREVENT was designed to remove some of the barriers to participation that older people commonly report.

How have we made it easier to recruit older people to this clinical trial?

  • We measured handgrip strength and walk speed in clinics to make it easier to identify people for who the study might be suitable.
  • Most study visits were done at home – this has enabled recruitment and retention of a much less mobile group of patients than is usually the case.
  • The use of a dedicated community research delivery team has helped deliver home study visits, freeing up the time of other researchers.
  • Simple inclusion/exclusion criteria have helped recruitment by enabling older people with a wide range of other medical conditions to take part.
  • We chose simple to collect outcomes that could be collected in the clinic or at home; taking blood and stool samples was still possible.

The results of the MET-PREVENT trial will be available in mid-2023, but we have succeeded in recruiting a group of participants that closely resemble people that we see in our Older People’s Medicine clinics – exactly the group of people who need to know if this treatment could help their muscle weakness.