BRIDGING THE GAP
Specialists say therapeutic trials should involve more people over 60.
he International Longevity Centre (ILC), a longevity think tank, has called for changes to how clinical trials are structured so that they improve the representation of age diversity.
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The Trial-and-Error report advises regulators, pharmaceutical companies, and academics to prioritise age diversity throughout clinical trials.
Older adults get more drugs than younger people. They are underrepresented in drug safety and efficacy trials. Over-60s received 60% of English community prescriptions from 2006 to 2016. A 2014 study indicated that a third of trials rejected people based on age, while a 2022 US investigation found that trials that included older adults still did not recruit the "oldest old" in adequate numbers. Since then, some positive moves have been done, but ILC claims they are not enough.
This new paper examines why trial design lacks age diversity through expert interviews and a roundtable discussion. The survey found that recruiting older individuals was costly in terms of clinical time and resources, especially since many older patients have health issues. Another hurdle is arbitrary age exclusion in trial procedures or in the trial team's decision to recruit (or not recruit)
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age-diverse cohorts. The ILC paper recommends ways to increase trial cohort age diversity. For example, age-related data is not collected in all trials. This information could reveal where older patients are underrepresented in trials.
ILC's research coincides with the UK Medicines and Healthcare products Regulatory Agency (MHRA)'s announcement of legislative amendments to speed clinical trial submissions. This legislation will provide guidance on how to “include patients meaningfully into the design and conduct of trials” and “achieve diversity in trials in a way that is proportionate and achieves the best results."
This comes shortly after the FDA proposed requiring diversity strategies from researchers for clinical studies. The recommendations support the immediate inclusion of historically underserved communities.
ILC Senior Health Policy Lead and study author Esther McNamara said, “Regulators, patient groups, academics, and pharmaceutical corporations agree that more elderly people should be included in trials. They can find the best therapies for their ailments. We interviewed a variety of professional stakeholders to develop
conclusions and offer recommendations in our research, which, if implemented, might promote substantial improvements that better serve older patients.”
“We urgently need clinical trial guidelines to put age diversity on par with gender and ethnicity. After these modifications, clinical trials will produce the proof older individuals deserve when prescribed medicines.”
RBW Consulting's Chief Commercial Officer, Emma Thorp, said, “We're happy to work with the ILC on this initiative as part of the push to make clinical trials more representative”
Miles Witham, Newcastle University, Professor of Trials for Older People added, “This work should help our clients and the industry create inclusive trials. The more we can discover and share practical answers, the more progress we will make, and we hope this work will sit alongside the wonderful efforts of others to make genuine change.”
This analysis shows that regulators, researchers, industry, and patients must work together to solve this problem.
Download the whole report at www. /
ilcuk.org.uk/trial-and-error/.
WE URGENTLY NEED CLINICAL TRIAL GUIDELINES TO PUT AGE DIVERSITY ON PAR WITH GENDER AND ETHNICITY
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