Call for ‘more trial, less error’ in study diversity

A report from a UK think tank focused on the impact of longevity on society has found that people aged over 60 are still poorly represented in clinical trials – even though they are often the group new therapies are being developed to treat.

The study by the International Longevity Centre (ILC) urges regulators, pharma companies, and researchers to prioritise age diversity at all stages of the clinical trial process, pointing out that 60% of all prescriptions written in England between 2006 and 2016 were dispensed to some aged 60 or over.

At the same time, a 2014 study found that a third of all clinical trials excluded subjects based on their age, while another study in the US in 2022 found that trials that were inclusive of older adults still did not recruit the ‘oldest old’ in sufficient numbers.

“In an ageing world, more and more of us will be using medications later in life,” says the report. “However, despite the majority of medicine users being aged 60 and over, many trials still exclude older people.”

Among the barriers to recruiting older subjects is cost – involving older participants can require more resource and flexibility from trial teams, particularly if they have existing health conditions – and a view that using younger people results in a ‘cleaner’, less complex dataset that improves the chances that a trial will be successful.

The ILC says, however, that a cleaner dataset does not accurately reflect how a medicine will perform in real-world settings for all patients who end up taking it.

While the issue is not new – regulators came together with the pharma industry way back in 1993 to make recommendations to address the problem – the pace of progress is too slow, according to the think tank.

Acknowledging that situation, the FDA recently published proposals to require diversity plans from researchers in order for new trials to be approved, while in the UK the MHRA has also announced legislative changes on trial applications that include a pledge to provide guidance on achieving diversity in studies.

“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,” according to the report’s author, Esther McNamara, senior health policy lead at ILC.

“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,” she said.

“These are the people who can ensure that the best treatments are found for the conditions that affect them most.”

The ILC report recommends that new guidelines be drawn up to push for age diversity in clinical trials via the International Council for Harmonisation (ICH) process – which sets technical standards for the pharma industry – and asks regulators to incentivise trial inclusivity.

Pharma companies and research groups should appoint champions to prioritise diversity, make use of technology to help older subjects participate, and prioritise gathering age-related data across all trials.