In this issue, we speak to Miles Witham, Professor of Trials for Older People at Newcastle University and consultant geriatrician, about why he’s bringing about a sea change in how clinical trials involving older people are designed and carried out.

Miles works in the NIHR Newcastle Biomedical Research Centre (BRC) which specialises in translational research relating to ageing syndromes and long-term conditions, drawing on the University’s longstanding expertise in this area.

Improving the physical function and quality of life for older people is at the heart of his work, but in order to achieve this, trials need to be designed appropriately to test interventions targeted at syndromes associated with ageing.

“My role is about designing trials that are right for older people and which are easy for them to take part in. There is not much research on how to do this – so part of our work is about building up the methodology evidence base on how to design successful trials for older people,” explains Miles.

It is timely work, for figures from the Office of National Statistics, show the UK’s population is getting older, with 18% of the population aged 65 and over and 2.4% aged 85 and over –  with these percentages set to increase over the coming years. Yet until recently, there was little research on how best to treat older people.

“In practice, older people haven’t been included in clinical trials – so we don’t have evidence of whether the findings apply to them,” explains Miles, “Given older people make up an increasing percentage of the population, it’s all the more important we find the treatments which work best for older people.

“We need to ensure the trials we’re conducting are right for the people we look after in the NHS these days. The population is ageing and few older people have only a single condition – increasingly people have multiple conditions or multimorbidity – yet traditionally research  hasn’t taken this into account.”

“Trial findings tend to be based on results from people with a single condition, and applying those findings to someone with multimorbidity doesn’t always work. The findings can be misleading and are not necessarily right for the people we see in the clinic. If we are going to give the right advice to older people so that they can make decisions about their healthcare, we need to ensure that we properly understand the balance of benefits and risks that a treatment has for older people.

With this in mind, Miles is working to improve the way that trials are designed and run, facilitating the participation of older people and building capacity across the UK to conduct trials specifically for older people.

“Running trials for older people is difficult – it’s something that academia and pharmaceutical companies have stayed away from because of the complexities and challenges involved.

“Trials for older people take more effort and they take longer. You need to recruit more people, as more adverse events happen and more people drop out, in addition, you’ll find that the population is not so homogenous as people grow older. As researchers, we need to embrace that complexity, it isn’t going to go away, we have to accept it as part of the package. Instead, we need to accept that we will need larger sample sizes and to ensure trials are adequately funded to support a larger sample size.

“A particular skill set is needed to help older people take part in clinical trials. Older people need time and space to think about their participation and an opportunity to discuss it with other people, in addition, their priorities tend to be different from those on which most clinical trials are based.

“The focus of many clinical trials is on whether you are dying or not – yet for most older people it is quality of life and physical function that matter most. It’s important we let patients’ voices be heard in designing our research projects and continue to listen to them throughout the research – so we produce findings relevant to them. Research should be about what’s right for the patient – not what’s right for the researcher.

“One of the challenges is looking in the right places for people to participate in our research and that’s not in hospitals, which are often not the most representative places to conduct research. Researchers need to reach out to the broader community – where, for example, are homeless people in our research? How do we ensure that those who don’t speak English are included?

“We’ve worked closely with GP’s and other primary carers in identifying and contacting older people suitable for studies – the community is where most older people live, so that’s where we should be doing our research. Until recently, care homes were neglected, but colleagues across the UK have been putting structures in place to engage with them too. We know that units that do research provide better care, so it’s a good thing for both residents and staff.

“Colleagues have also worked with libraries, sheltered accommodation and football clubs, amongst others. When I worked in Scotland, we knew that thousands of retired people played bowls – so we contacted local bowls club to recruit people to our studies. As researchers, we need to be more creative in how we contact potential participants.”

“Regulators have a role too. If pharmaceutical companies want to produce and market medications for older people with multiple conditions, we need to make it a condition of marketing approval that they’ve conducted trials that involve older people with multiple conditions.”

One study underway that’s embraced older people is the LACE Trial into sarcopenia, the loss of muscle size and strength that happens as we age. This medical research study for people aged 70 years old and over who have muscle weakness is examining whether Leucine and ACE inhibitors can act as therapies to improve muscle size and strength.

Trials such as this represent a major breakthrough. Sarcopenia has only recently been given an ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) code, so few studies have looked at the condition, even though it’s estimated to affect around one in ten people over the age of 75.

Another of Professor Witham’s trials is examining the use of sodium bicarbonate to treat high acid levels in older people with advanced kidney disease, a treatment which has long been used but for which there is little supporting evidence. The study has deliberately targeted older people with chronic kidney disease, who’ve been neglected in previous studies, with the aim of establishing whether or not this accepted treatment works. We await the results with interest.

Organ specialists, Miles explains, have an important role to play in recruiting older people to clinical trials. Nowhere is this more evident than in the area of cardiology.

A British Heart Foundation funded study (the SENIOR-RITA trial), led by Newcastle, is examining whether current UK practices for treating heart attack patients are the most suitable treatment for those aged over 75. This is all the more important when you realise that over 50% of heart attacks happen in patients aged 75 and over and many have other health problems too.

“These research projects are good examples of what we need to do in order to engage more people in clinical trials and ensure the outcomes are relevant for our patients. All in all, we need to realign our recruitment and research structures so they are where people are and ensure the research we’re doing is relevant to the target group.

“Making it easier for older people to take part in and stay in our clinical trials is crucial if we are to generate better outcomes from our research.”