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 US Food and Drug Administration 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. 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 policymakers.
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 its 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 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 patient-focus is embedded in a 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.
References are available on request.
