Diversity, Equity and Inclusion in Clinical Research

Fair and timely access to efficacious medicines is one of the important tenets of the Life Science industry and a critical building block of the sector’s Environmental, Social and Governance (ESG) objectives.

Life Science companies that can demonstrate a diverse and inclusive clinical trial data set, to support the safety and efficacy of their products, will not only secure payer and regulatory approval, but also improved patient confidence and uptake of their medicine. There is also is a real market opportunity for Life Science companies, to gain a competitive advantage by conducting clinical research in more representative patient groups, addressing areas of unmet medical need in underrepresented populations. Life Sciences companies who can address these issues will demonstrate a clear value proposition and differentiation for their product in a crowded market.

This article will discuss the importance of clinical trial diversity, equity, and inclusion for patients, regulators, payers and Life Science companies, and will seek to explain why all stakeholders should promote evidence-based enrolment of diverse patient groups into clinical trials.

As we outline below, by building an infrastructure and framework which promote the inclusion of diverse patients, who represent the intended patient population, this can lead to improved patient safety and efficacy for new medicines.

• Why clinical research in diverse populations matters, and the importance of intrinsic and extrinsic factors (ICH E5 R1(1998)), and how randomized clinical trials (RCTs) do not always translate to the real world ‘effectiveness’ of a medicine.
• How the nuances of sex and gender are important considerations when evaluating data from clinical trials.
• Ethnicity and how Life Science research programs may overcome barriers and utilize population pharmacokinetics more effectively.
• Older populations and the opportunity for more inclusion and the generation of broader data sets.
• The impact of the COVID-19 rapid vaccine development program and the disparities in health outcomes for different patient populations.
• How global regulators have adapted to the important challenges and opportunities of addressing diversity, equity, and inclusion.
• Opportunities to address the disparity in population health outcomes by starting with more accurate data from clinical trials.
• Next steps for the future of diversity, equity, and inclusion in clinical research.

_{Original source: KPMG UK, https://home.kpmg/uk/en/home/industries/life-sciences.html}