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Why age is important in clinical trials

More needs to be done to recruit older people in clinical trials, a leading geriatrician argues.

Professor Miles Witham, who is the co-theme lead for Ageing, Sarcopenia and Multimorbidity at the National Institute for Health and Care Research (NIHR) Newcastle’s Biomedical Research Centre (BRC), says it is vital older people are included in trials to ensure they benefit from effective treatments.

Older people have often been excluded from research in the past. But the academic, who is also professor of Trials for Older People at Newcastle University, asserts it is important to change that mindset.

Speaking at a public meeting in Newcastle, Prof Witham told the audience it couldn’t be assumed because a treatment worked in one group, it would be suitable for older people.

This was most notable where research involves younger people, as older generations tend to suffer from multimorbidity (two or more long-term health conditions) as opposed to a single disease.

As such, many older people’s needs are very different from their younger counterparts.

It was only by including older people in trials that the evidence could be gathered to ensure the right interventions, treatments and diagnosis needed were being made for effective delivery in clinical practice.

Prof Witham, whose interests span physical function and quality of life in older people as well as cardiovascular and kidney diseases, and dementia, has been a long-time advocate of designing and delivering better trials for older people.

Reflecting on the public meeting, he said: “Older people are a group that get ill more often 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.”

Of the talk, Prof Witham described it as 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.”

The NIHR Newcastle reports one recent trial where older people were successfully recruited, however.

The MET-PREVENT trial, which recruited 72 over 65s from Newcastle and Gateshead with muscle weakness as shown by a slow walking speed and reduced hand or leg strength, 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 group wouldn’t usually find it easy to take part in clinical trials, so MET-PREVENT – the results of which are expected in mid-2023 – was designed to remove some of the barriers to participation that older people commonly come up against.

The trial team made it easier to recruit the right participants by:

 

 

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