A new report from the International Longevity Centre (ILC), a specialist think tank on longevity, urges action to ensure medicines are tested on the people they are supposed to help.

The Trial and error report, published today, urges regulators, pharmaceutical companies and researchers to prioritise age diversity at all stages of the clinical trial process.

Older people are prescribed more medications more frequently than other age groups. Yet they are consistently underrepresented in the trials testing the safety and efficacy of medicines. Between 2006 to 2016, 60% of all community prescriptions in England were dispensed to people aged over 60. A 2014 study found that a third of trials excluded people purely on the basis of age; another study in the US from 2022 found that trials that were inclusive of older adults still did not recruit the “oldest old” in sufficient numbers. Some steps have been taken in the right direction since then, but ILC argues that the action being taken does not reflect the scale of the problem.

Based on in-depth expert interviews and a roundtable discussion, this new report unpicks why age diversity lags in trial design. Among the barriers to age parity, the report finds that added costs (in terms of clinical time and resources) of recruiting older patients was prohibitive to inclusion, particularly since many older patients have existing health conditions. Another barrier is arbitrary exclusion of participants on the basis of their age – this could be direct in trial protocols, or indirect through the decisions of the trial team to recruit (or not recruit) age-diverse cohorts. The ILC report suggests practical steps towards improving age diversity in trial cohorts. For example, age-related data is not consistently gathered across all trials, particularly those testing medications for conditions not associated with ageing. Doing so would help us better understand where older patients’ participation is lacking, and which trials successfully include significant numbers of older people.

ILC’s report has been published just as the UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a series of legislative changes designed to streamline clinical trial applications. Guidance will accompany this change in legislation, outlining how trials can “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 some weeks after the American Food and Drug Administration’s (FDA) proposals to require diversity plans from researchers in order for clinical trials to be approved. The proposals aim to support the inclusion of historically underserved groups, which is urgently needed.

Esther McNamara, Senior Health Policy Lead at ILC and author of the report explains:

“This issue has rumbled on for many years; regulators, patient groups, researchers and pharmaceutical companies agree that a concerted effort is required to include more older people in trials. These are the people who can ensure that the best treatments are found for the conditions that affect them most. We spoke with a range of expert stakeholders to reach conclusions and make recommendations in our report which, if implemented, could support huge changes that better serve older patients.”

“These new initiatives by the US and UK government agencies are timely, but we urgently need guidelines for clinical trials to put age diversity on a par with gender and ethnicity.  We make recommendations in this report that affect stakeholders at all stages of the trial process. Only once these changes have been made, will clinical trials generate the evidence that older patients deserve when they are prescribed medicines.”

Emma Thorp, Chief Commercial Officer at RBW Consulting, a certified B Corp company specialising in life science search and recruitment who provided support for the project as part of their ongoing CSR programme said:

“We are proud to have partnered with the ILC on this project. Against the backdrop of the United Nations decade of healthy ageing, it felt like the right time to drill down into the needs of older people as part of the movement to make clinical trials more representative.

“It’s our hope that this work will support our clients and the industry in general with inclusive trial design. 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.”

Miles Witham: University of Newcastle, Professor of Trials for Older People

“This report reinforces the fact that we can’t tackle this issue with isolated initiatives – we need a broad-spectrum approach right across regulators, researchers, industry and patients in order to bring about the required change.”

The full report can be downloaded here https://ilcuk.org.uk/trial-and-error/

A webinar held to discuss the report findings can be viewed here.

Ends

Contact

Contact press@ilcuk.org.uk or +44 (0) 7736 124 096 for press queries. Spokespeople are available for interview.

Notes

The ILC, with the support of RBW Consulting, undertook this research to better understand what prevents older people’s participation in clinical trials and the possible implications of this for the efficacy of trials and equity of healthcare outcomes. For the full report: https://ilcuk.org.uk/trial-and-error/

The ILC organised a roundtable discussion and a series of interviews to gather expert insights. Participants included expert stakeholders from Pharma & Biotech companies, CROs and DCTs (and other life science vendors), medical professionals, regulators, patient engagement groups, and NGOs.

A 2014 study of the Participation of older people in preauthorization trials of recently approved medicines found approximately a third of clinical trials exclude people purely on the basis of age (Beers et al 2014).

In the general population, the use of prescription drugs increases with age. European data show that 46% of the European population in the age group 45–54 years use prescribed medicines. This number increases to 87.1% in those aged 75+ years (Underrepresentation of the elderly in clinical trials, time for action – Marum – 2020 – British Journal of Clinical Pharmacology – Wiley Online Library)

The 2011 PREDICT study of professional views across nine European countries reported that older people and those with co-morbidity continue to be excluded unjustifiably from clinical trials. There was agreement from those surveyed that exclusion from clinical trials on age grounds alone was unjustified (87%) and that under-representation of older people in trials caused difficulties for prescribers (79%) and patients (73%). Older people tend to agree that age alone is an insufficient reason for exclusion from clinical trials. Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study – https://pubmed.ncbi.nlm.nih.gov/21812501/

A 2022 study reviewed 166 clinical trials using data from the US Food and Drug Administration and found that adults in the oldest age groups (aged 75 and older) tended to be underrepresented in some therapeutic areas more than others. Representation of patients aged between 60 and 75 was reasonably proportional to the prevalence of the disease or symptoms in that age group. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797323

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