Driving market access through clinical trial diversity

High angle view of people on a street


By Sue Neilen, Senior Director

Following the pandemic, improving clinical trial diversity through increased representation was identified as a critical priority for many life sciences companies. But where should life sciences companies focus their efforts?

In 2020, when words like ‘lockdown’, ‘bubbles’ and ‘social distancing’ had seeped into our everyday vernacular, the virus did something unexpected. Unexpectedly positive. In turning the world on its head, COVID-19 shone a spotlight on health inequalities and their impact on specific ethnic groups, who despite having a disproportionate risk for certain diseases, are significantly under-represented in clinical trials. People everywhere recognised that irrespective of age, gender or ethnicity, everyone should have the opportunity to participate in and benefit from medical research.

The sea change had been building. EU drug regulators were placing increased emphasis on diversifying clinical trials through a fairer representation of gender and age groups. The UK government had announced guidance to help researchers achieve proportionate diversity, and the US Food and Drug Administration signalled its intentions. Between 2014 and 2019, ethnicity- based, post-marketing studies were demanded for six newly approved molecular entities and in 2022, Lilly was declined approval for a lung cancer drug after concerns were raised about the lack of population diversity in a single-country trial in China. It had become increasingly clear that demonstrating a diverse participant base would be key for regulatory approval.

Here are three top considerations to help engage a diverse group of clinical trial participants:

  • Build trust with minority stakeholders. Drive understanding and awareness of clinical trials through advocacy engagement, transparency and culturally sensitive communications. These communications can foster trust and emphasise the benefits of research to ethnic minority groups (eg, multi-platform, accessible, multilingual materials)

  • Engage during clinical trial planning. Early-stage consultation with the community to facilitate planning and trial design addresses ethnic sensitivities and perspectives to speed recruitment, improve adherence and deepen long-term commitment (eg, tailored content via channels and formats specific to each audience)

  • Drive internal awareness of recruitment best practices. Develop processes to raise internal team awareness of the importance of diverse CT populations and drive change in recruitment approach.

For more information and insights about how clinical trials can support market access, contact Sue Neilen at sue.neilen@inizioevoke.com.

Read the article on PMLive.