Trial and Error - do our clinical trials match the ages of those who need medicines most?

Trial and Error - do our clinical trials match the ages of those who need medicines most?

The International Longevity Centre (ILC), the UK's specialist think tank on longevity, is launching an international project, supported by RBW Consulting, to explore and tackle barriers to age diversity in clinical trials.

The issue of age discrimination in clinical trials has remained on the agenda of governments and regulators for many years. We have seen clinical trials become more inclusive in recent decades, but the representation of older patients still lags, even when testing medications that will predominantly be prescribed to older patients. As medications and medical interventions get tested during trial phases, research shows approximately a third exclude people on the basis of their age. Statistics around the inclusion of over-65s and over-75s vary. Studies testing medicines specifically intended for older people tend to have more older participants than for medicines for all adults. Nonetheless, both categories could benefit from the greater participation of older adults. Diverse cohorts help to provide a good evidential base that the medication is effective for different groups.

Without sufficient evidence that medicines work for older cohorts, there is cause for concern that older people might be adversely affected by drugs and other medical interventions. The physiological effects of ageing coupled with comorbidity and polypharmacy – when people have multiple conditions and/or are prescribed multiple medications could alter the efficacy of a drug. The ILC is gathering evidence and solutions to help stakeholders improve the participation of older people in clinical trials. This evidential gap between younger and older trial participants is unacceptable and could lead to inappropriate prescribing or a greater risk of adverse events, warn spokespeople at ILC.

Esther McNamara, Senior Health Policy Lead at ILC argues:

"All too often it seems that medicines are not necessarily tested on the people that they are supposed to help. Is this because of important clinical or ethical reasons? Are there particular barriers to participation? Could arbitrary age-related barriers be a possible explanation for low participation rates, and, if so, how can we address this?

“Answers to such questions are important as we’re talking about medicines that any of us could be prescribed, especially as we get older. We are really interested in diverse perspectives on this issue - the more we know about how older people interact with clinical trials, the more we can ensure policy and practice in this area is more inclusive."

ILC is convening an expert roundtable exploring the barriers to more diverse participation in clinical trials and the possible implications of this for the efficacy of trials and equity of healthcare outcomes.  The intention is to report on this project before the end of March 2023.

The roundtable discussion will seek to build an up-to-date picture of the barriers to older people’s participation in clinical trials, which treatments this most likely affects, and importantly how these barriers can be overcome.

Emma Thorp, Chief Commercial Officer – EU & North America, RBW Consulting, said,

“We are delighted to be partnering with ILC to delve deeper into the topic of age inclusivity in clinical trials. The project is a key part of our RBW IMPACT programme, which sees us contribute pro bono to work that aims to fulfil an unmet need, whether that is a shortage of knowledge, data, discussion or practical implementation on important issues within the health/ life science sector.” 

“Through our day-to-day core work, we have heard from clients and our wider network that while there is a unilateral acceptance of the need to improve representation in trials, there is still so much to be done to move from rhetoric to reality. The more we can identify and share practical solutions, the more progress we will make, and our hope is that this work will sit alongside the excellent efforts of others, to make real change happen”.