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

This risks people taking medications that may not be as effective for them as they could be, or even worse, that lead to adverse reactions. Most clinical trial stakeholders agree that drug trials should include all groups who will find them useful. However, there are a number of barriers to conducting age-diverse trials:

Cost

• Involving older participants can require more resource and flexibility from trial teams. It’s often considered easier and cheaper to use younger, healthier cohorts, as they are understood to carry a lower risk of adverse events. This is an assumption about older patients that requires further interrogation.

‘Clean’ data

• Recruiting younger cohorts often results in ‘cleaner’, less complex data sets. This can make any conclusions drawn about the efficacy of the medicine less accurate and less generalisable to larger populations.
• Removing older participants tends to remove some of the necessary complexity, including comorbidities and concomitant medications.
• Although ‘clean’ data may sound preferable, it reduces the nuance and diversity necessary in a trial and doesn’t help researchers to understand whether medicines are safe and effective for all patients who may take them.

Arbitrary exclusions

• Some trial protocols allow individuals to be excluded from participation due to other diagnoses or concerns about compliance. Protocols may exclude certain groups (such as older people) disproportionately and without good reason.

Practical considerations

• The burden of treatment, and access difficulties, may form practical barriers for many older people.

Three decades ago, in 1993, pharmaceutical regulators came together with the industry to identify wide-ranging concerns about the lack of age diversity in clinical trials and then made recommendations to improve this.

Over recent decades we have seen an increase in initiatives to improve inclusion of underrepresented groups, particularly with regards to gender and race. However, we have not seen enough progress on age diversity to match this. Recent developments in remote and flexible trial designs have made participation more accessible than ever. Yet action is required across the board to ensure that older patients are able to leverage this increased accessibility. We need structural and cultural change to ensure that the people who use medications and treatments are adequately represented in the trial process.

This research was made possible with the kind support of RBW consulting.