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Why age is important in clinical trials

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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:

  • Measuring handgrip strength and walk speed in clinics to make it easier to identify people for who the study might be suitable.
  • Ensuring most study visits were done at home, enabling recruitment and retention of a much less mobile group of patients than is usually the case.
  • Using a dedicated community research delivery team, freeing up the time of other researchers.
  • Making the inclusion/exclusion criteria simpler so older people with a wide range of other medical conditions could take part.
  • Choosing simple to collect outcomes that could be gathered in the clinic or at home.

 

 

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Tai chi outperforms conventional exercise for seniors

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New findings from 12 studies involving 2,901 participants have demonstrated that tai chi outperforms conventional exercise in improving mobility and balance in seniors.

While tai chi is understood to be beneficial for functional mobility and balance in older adults, such benefits are not well understood due to large variance in research study protocols and observations.

This new review and analysis has now shown that tai chi can induce greater improvement in functional mobility and balance in relatively healthy older adults compared to conventional exercise.

The findings showed the following performance results:

  • The time to complete 50-foot walking was 1.84 seconds faster. 
  • The time to maintain a one-leg stance was 6 seconds longer when eyes were open and 1.65 seconds longer when eyes were closed. 
  • Individuals improved their timed-up-and-go test performance by 0.18 points, indicating quicker standing, walking, and sitting.
  • Individuals taking the functional reach test showed significant improvement with a standardised mean difference of 0.7, suggesting a noteworthy positive impact on the ability to reach and perform daily activities.

Secondary analyses revealed that the use of tai chi with relatively short duration of less than 20 weeks, low total time of less than 24 total hours, and/or focusing on the Yang-style of this ancient form of Chinese martial arts were particularly beneficial for functional mobility and balance as compared to conventional exercise.

“This systematic literature review and meta-analysis are exciting because they provide strong evidence that tai chi is a more efficient strategy to improve functional mobility and balance in relatively healthy older adults, as compared to conventional exercise,” said Brad Manor, Ph.D., director of the Mobility and Falls Program at Hebrew SeniorLife’s Hinda and Arthur Marcus Institute for Aging Research, and associate professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center.

“This research suggests that tai chi should be carefully considered in future studies and routines of rehabilitative programs for balance and mobility in older adults,” said Bao Dapeng, professor at Beijing Sport University.

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New standards for biomarkers of ageing

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A paper has put forward a new framework for standardising the development and validation of biomarkers of ageing to better predict longevity and quality of life.

Led by Harvard researchers, the team has zeroed in on biomarkers of ageing using omic data from population-based studies. 

The team included ageing and longevity expert Alex Zhavoronkov, PhD, founder and CEO of AI-driven drug discovery company Insilico Medicine, and the findings appeared in Nature Medicine

Ageing is associated with a number of biological changes including increased molecular and cellular damage, however, researchers do not yet have a standardised means to evaluate and validate biomarkers related to ageing. 

In order to create those standards as well as actionable clinical tools, the team analysed population-based cohort studies built on omic data (data related to biological molecules which can include proteomics, transcriptomics, genomics, and epigenomics) of blood-based biomarkers of ageing. The researchers then compared the predictive strength of different biomarkers, including study design and data collection approaches, and looked at how these biomarkers presented in different populations. 

In order to better assess the impact of ageing using biomarkers, the researchers found that clinicians needed to expand their focus to consider not only mortality as an outcome, but also how biomarkers of aging are associated with numerous other health outcomes, including functional decline, frailty, chronic disease, and disability. They also call for the standardisation of omic data to improve reliability. 

“Omics and biomarkers harmonisation efforts, such as the Biolearn project, are instrumental in validation of biomarkers of aging” said co-first author Mahdi Moqri, PhD, of the Division of Genetics. 

Biolearn is an open-source project for biomarkers of aging and is helping to harmonise existing ageing biomarkers, unify public datasets, and provide computational methodologies.

The team also emphasised the importance of continued collaborations among research groups on “large-scale, longitudinal studies that can track long-term physiological changes and responses to therapeutics in diverse populations”, and that further work is required to understand how implementation of biomarker evaluation in clinical trials might improve patient quality of life and survival.

“If we hope to have clinical trials for interventions that extend healthy lifespan in humans, we need reliable, validated biomarkers of ageing,” said co-first author Jesse Poganik, PhD, of the Division of Genetics. 

“We hope that our framework will help prioritise the most promising biomarkers and provide health care providers with clinically valuable and actionable tools.”

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Healthy aging research to receive $115 million

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Global non-profit Hevolution Foundation has announced $115 million in funding that makes up 49 new awards under its Geroscience Research Opportunities (HF-GRO) programme.  

As part of Hevolution’s mission to catalyse the healthspan scientific ecosystem and drive transformative breakthroughs in healthy aging, HF-GRO is funding promising pre-clinical research in aging biology and geroscience. 

Through this first wave of HF-GRO awards, Hevolution will invest up to $115 million in this first cohort of 49 selected projects over the next five years. Its second call for proposals under HF-GRO will be announced later this year, offering an additional $115 million to address the significant funding gaps in aging research.  

Dr. Felipe Sierra, Hevolution’s Chief Scientific Officer stated: “These 49 important research projects represent a significant step forward in deepening our understanding of healthy aging. Hevolution’s prime objective is to mobilise greater investment around uncovering the foundational mechanisms behind biological aging. 

“We are steadfast in our belief that by examining the root causes of aging, rather than solely focusing on its associated diseases, we can usher in a brighter future for humanity.” 

HF-GRO awardees include researchers at prestigious institutions across the United States, Canada, and Europe, including the U.S. National Institute on Aging, Brigham and Women’s Hospital, the Buck Institute, the Mayo Clinic, New York University, and the University of California San Francisco, among many others. 

The American Federation for Aging Research is providing programmatic support for the HF-GRO program, with grantees selected through a rigorous two-stage peer-review process involving 100 experts in aging biology and geroscience. 

Dr Berenice Benayoun, an HF-GRO grant recipient at the University of Southern California, stated: “I am extremely honored and excited that Hevolution selected our project for funding. This is a project close to my heart, which aims at understanding why and how the female and male innate immune aging differs. 

“This funding will support us as we start laying the foundation for a lasting improvement of women’s health throughout aging.” 

To date, Hevolution has committed approximately $250 million to transform the healthy aging sector, including the $40 million for specialised research and development in healthspan science recently announced at Hevolution’s Global Healthspan Summit. 

Hevolution is ramping up its investments to enable healthier aging for all and is now the second largest funder of aging biology research worldwide.  

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