Improving health outcomes by increasing patient diversity in clinical trials
Medical Content Team February 22, 2022
Equity, diversity, and inclusion (EDI) are hot topics in all aspects of society, from Hollywood blockbusters to the workplace, and although it might not be obvious, in clinical trials. A 2020 analysis from the US Food and Drug Administration (FDA) emphasized the disparity between the diversity of trial participants and the global population. It showed that the composition of the global clinical trial population was 76% White, 11% Asian and 7% Black/African American.1 In contrast, around 59% of the global population is distributed in Asia, 18% in Africa, 9% in Europe, 8% in North America, and 6% in South America.2
It is clear that not all clinical trials are representative of the populations that are likely to receive treatment in clinical practice. This is important because taking part in a clinical trial is likely to confer benefits to participants through improved care. Additionally, lack of diversity in a clinical trial context can hinder understanding of the effect of investigative therapies in population subgroups and real-world application,3,4 which in turn may lead to limited access for certain groups or to delays while additional trials are performed. Around 20% of drugs approved between 2008 and 2013 have interracial/ethnic variations in terms of pharmacokinetics, efficacy, safety, dosing or pharmacogenetics.5
Recruitment of diverse populations within clinical trials is not straightforward. There are many well documented reasons for why clinical trial participation is lower in certain groups – some geographical, some financial, and some cultural.6 Any strategy to encourage greater diversity needs to address a broad range of factors that currently hinder participation.
The FDA has released guidance on potential approaches that sponsors of clinical trials could adopt to improve the enrollment of underrepresented populations. This covers topics such as broadening eligibility criteria and accounting for logistical and other participant-related factors that could potentially limit clinical trial participation.7
The Medicines and Healthcare products Regulatory Agency has recently launched a consultation on UK clinical trials legislation, which includes a question on if and what type of legislative requirements should be introduced to support diversity in clinical trial populations.8
It is great to see medical organizations and societies putting EDI at the heart of activities. This year’s American Academy of Allergy Asthma & Immunology Annual Meeting 2022 Keynote from Dr. Hannah Valantine, MD, is on The Importance of Diversity in Academia and Team Performance. This presentation will cover evidence on the value of diversity and strategies to promote an inclusive culture in academia.9
All of us should be doing our bit – at Remedica we have a committee, we’ve audited our processes… but we know that embracing EDI is a journey without a finish line. There’s always more to learn. That’s why we’re particularly excited to listen to Dr. Valantine and learn how we can further embed processes to improve diversity within the company.
FDA. 2015-2019 Drug trials snapshots summary report. Five-year summary and analysis of clinical trial participation and demographics. 2020. https://www.fda.gov/media/143592/download (Accessed 7 February 2022).
https://worldpopulationreview.com/continents (Accessed 8 February 2022).
Gray DM 2nd, et al. Diversity in clinical trials: an opportunity and imperative for community engagement. Lancet Gastroenterol Hepatol. 2021;6(8):605-607.
Bodicoat DH, et al. Promoting inclusion in clinical trials-a rapid review of the literature and recommendations for action. Trials. 2021;22(1):880.
Ramamoorthy A, et al. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin Pharmacol Ther. 2015;97(3):263-73.
Clark LT, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol. 2019;44(5):148-172
FDA. Enhancing the diversity of clinical trial populations – Eligibility criteria, enrollment practices, and trial designs guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial (Accessed 31 January 2022).
Gov.uk. https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials/proposals-for-legislative-changes-for-clinical-trials (Accessed 31 January 2022).
AAAAI. https://annualmeeting.aaaai.org/ (Accessed 31 January 2022).