Moving beyond vanilla to improve patient diversity in clinical trials

Enabling greater patient diversity in the development of medicines is a clear priority for our industry as regulators become increasingly concerned by the uneven reflection of population demographics in study samples.

In a 2020 analysis of global participation in clinical trials, the FDA highlighted major discrepancies between trial participants and the global population. Of 292,537 participants, 76% were white, 11% were Asian and only 7% were Black.^[1] In comparison, three quarters of the global population is comprised of Asians and Africans alone.

No silver bullet

It is a complex matter with no silver bullet solution. Instead, a concerted effort from all stakeholders is needed, including regulators, healthcare providers, patient and community organisations, the pharmaceutical industry and policy makers.

However, there are some straightforward patient-focused solutions that can be executed, which can make a significant difference.

In many clinical trial recruitment strategies, we often see a somewhat vanilla design, lacking sufficient consideration for the diverse populations they need to engage.

Deep patient connection

We know from experience that strategies co-designed in partnership with patients – and fuelled by insight from all target demographics – are more successful. They enable us to create a deep connection with each patient population, reflecting their experience – physical, emotional and information seeking.

Our unique approach starts with an insights-led patient experience mapping exercise to identify the required participant profiles; what they will wish to gain and avoid from participation; the points in their experience when they are most likely to participate; and the channels and tactics to best reach and engage them.

We then work with patients who fit the identified profiles to co-design all trial materials globally, and take it a step further at a country level, testing globally designed strategies and materials with local patient audiences.

When a patient-focus is embedded in the way we think and work – from the very first planning meeting right through to study completion, we are more likely achieve representative study populations, ultimately leading to better treatments.

[1] U.S. Food & Drug Administration. 2015–2019 drug trials snapshots summary report. FDA https://www.fda.gov/media/143592/download.

If you want to find out more about how we can help accelerate your clinical trial recruitment strategy, please reach out to Stephen O’Farrell (stephen.ofarrell@auroracomms.com) who is Head of Patient Engagement at Aurora Healthcare Communications.