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10 ways to improve diversity, equity, and inclusion in clinical trials
Elena Jouravleva of US Oncology Research, and Brenda Stoltz of BURG Translations, talk about why this is crucial to future success.
A
re your trials including minorities most impacted by the disease? Building diversity, equity, and inclusion (DEI) clinical trials improve trial accuracy and help you reach those most needing the treatment. It requires changes in every area of the trial, from planning and recruitment to how you run the trial.
Learn ten ways to improve diversity, equity, and inclusion in clinical trials for better outcomes.
What Are the Differences Between Diversity, Equity, and Inclusion? DEI overlaps, but they have distinct meanings: • Diversity: Includes a wide range of differences such as gender, sexual orientation, religious values, social class, physical abilities, and heritage
• Equity: Provides fair situations for everyone and it accounts for differences in ability and background
• Inclusion: Includes everyone in a diverse group by supporting their differences so they can participate in a trial
Why Are Diversity, Equity, and Inclusion Important? In the past, there has been a severe lack of diversity in trials. An evaluation examining participants in trials between 1997 and 2014 across 29 countries found 86% of participants were white.1 A diverse and involved trial group ensures
the results reflect the groups most likely impacted by the condition. It also monitors a wider range of potential outcomes impacted by genetic or socio-economic factors. Because of the importance of DEI in clinical trials, the FDA legally requires it.4
56 | Outsourcing In Clinical Trials
Examples of DEI in Clinical Trials The National Institute on Minority Health and Health Disparities shared two situations where DEI positively impacted clinical trial outcomes:2 • COVID-19: The disease affected racial and ethnic minorities more than majorities, requiring a diverse population during the treatment trial stages.
• Asthma: Those in cities and high- population areas are more likely to experience asthma symptoms.
10 Ways to Improve the Diversity, Equity, and Inclusion of Your Trials How can researchers include DEI in their trials? Here are ten strategies to lay the foundation:
1. Establish DEI Goals During trial planning and protocol development, create DEI goals based on the collection and analysis of racial and ethnic data. The FDA requires your goals to include:6 • Goals for trial enrollment • Reasons for your goals • How you’re planning to meet the goals
These goals include target numbers from each demographic. Researching which demographics are most impacted by the disease helps guide your DEI goals, as you will want to focus on those demographics in your study. You will monitor these demographics before,
during, and after to ensure patients from various demographics actively participate in the entire trial.
2. Broaden Your Marketing Strategies If you aren’t reaching a target demographic,
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