IN PARTNERSHIP
Why is diversity important in clinical trials? A lack of comprehensive data makes it difficult for regulators and physicians to understand how medical treatments and medications behave in certain populations. Different races and ethnicities often respond differently to medical products, leading to variances in pharmaco- kinetics, efficacy and safety. Differences are related to intrinsic and extrinsic factors: • Intrinsic – genetics, metabolism, elimination.
• Extrinsic – diet, environmental exposure, sociocultural issues.
To account for variances, researchers must
focus on recruiting diverse participants to achieve clinical relevance. For example, epidermal growth factor receptor (EGFR) mutations occur in 30% to 40% of non-small cell lung cancer in Asian populations compared with 10% to 15% in Western populations. This is significant because Asians represent 5.6% of the total US population, yet less than 2% of the Asian population is represented in clinical trials. Increasing clinical trial diversity leads to
improved medical care, better targeted treatments for minority population segments, and better overall health outcomes. Here are some best practices for improving diversity in clinical trials:
1. Use translation services Language barriers are a major obstacle for many minority participants. The US Food & Drug Administration (FDA)
recommends providing trial resources and documents in multiple languages or organising interpreters for participants with limited English comprehension. This is to increase the participation and retention of individuals with limited understanding. While some sponsors have guidance and
processes that dictate translation services only if they enrol three subjects of the same language, US Oncology Research’s affiliated IRB requires that informed consent forms will be available in other languages if a research participant does not understand English. This practice has significantly reduced research participant barriers to entry. Because US Oncology Research manages about 400 high-risk trials annually, its affiliated IRB also requires all research participants who
have provided consent in a short form to provide consent again with a fully translated version of the informed consent form (ICF) before participation in a clinical trial. Translation services can significantly reduce participant entry barriers and improve the accuracy of clinical trial data.
2. Remove barriers Under-enrolment of diverse groups in clinical trials has been a long-standing issue for researchers. Contributing factors include a shortage of suitably qualified investigators in under-represented communities and clinics, budget constraints, and a general lack of resources. Participant barriers to enrolment include
the following: • mistrust/fear • impact of social determinants of health • lack of information about clinical trials • discomfort with the clinical trial process • logistical constraints • language barriers Language barriers can delay clinical trial timelines and participant access to treatment. To avoid delays in document translation, US Oncology Research uses a single vendor to handle all elements of translation services.
3. Make reasonable accommodations Some participants require special accommodations due to disabilities and may be physically unable to participate unless their needs are addressed. Minority populations may have fewer
resources, such as childcare and transportation, interfering with participating in clinical trials. Elderly adults often have physical limitations that
“Under-enrolment of diverse groups has been a long-standing issue. Contributing factors include a shortage of suitably qualified investigators in under- represented communities and clinics, budget restraints and a lack of resources.”
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