The FDA Wants Improved Clinical Trial Diversity. Here’s How Patient Engagement and Recruitment Services Can Help

The FDA Omnibus Reform Act of 2022 (FDORA), signed into law in December of 2022, includes clinical research guidances and recommendations on everything from decentralized trials and BIMO inspections to accelerated approvals.¹ The most pressing change, however, is the FDA’s requirements for diversity in clinical trials.  

Per FDORA, the FDA has expanded their diversity focus to include not only race and ethnicity but also other demographics such as sex, gender identity, age, socioeconomic status, disability, and more, and made diversity action plans a requirement for clinical trials.² This means, as a sponsor, you need to establish your study’s diverse patient enrollment goals, the rationale behind the goals, and, perhaps most importantly, an explanation of how you intend to meet them. 

Considering clinical trial enrollment is already challenging, the added diversity focus might seem overwhelming. How are you supposed to enroll patients from different demographics?  

The Clinical Trial Patient Engagement Solution  

Elligo Health Research^® offers Patient Recruitment and Engagement Services to attract, engage, and retain patients at every study stage. Beyond comprehensively connecting with patients from all walks of life to thoroughly engage them in the research process, this service helps you meet the FDA’s diversity requirements in three unique ways:  

1) Study Materials Development  

Patient Recruitment and Engagement Services include the development of patient-friendly study materials such as a website, advertisements, and outreach through SMS texts and emails. What does this have to do with clinical trial diversity?  

About 60 million American adults have limited health literacy.³ So, unless study materials are written in plain, inclusive language, your trial won’t be easily accessible for a majority of potential participants.  

From websites and ads to brochures, visit reminders, and more, our study materials focus on simplicity and readability with short and familiar words, active voice, short sentences, and 6^th to 8^th grade reading levels. We also optimize text formatting and visuals with easy-to-read fonts, headers, simple illustrations, and more to make materials accessible.  

2) Study Materials Translation  

In the U.S., 22% of people speak a language other than English at home and 8.4% of people speak English “less than very well,” making translated study materials essential for engaging diverse research participants.⁴ Furthermore, recruiting people with limited English proficiency (LEP) without clear translations of informed consent documents calls the study’s ethics and data integrity into question.  

To effectively and ethically engage LEP participants, our services for study materials development also help with identifying the top languages in your targeted populations and translating documents and resources as needed.  

3) Direct Outreach  

Connecting with patients in their communities is perhaps the most effective strategy for increasing clinical trial diversity.⁵ By establishing relationships with communities and partnering with leaders and community-based organizations, you can disseminate essential research information, foster trust, and engage diverse patients. 

Our Patient Recruitment and Engagement services do just this. We understand a patient’s economic, social, and physical factors greatly impact how they approach their health, so we work hard to approach patient engagement through each of these lenses with patient partnerships, community outreach, local campaigns, and even boots on the ground to answer questions and connect.  

Increase Your Clinical Trial Diversity With Patient Recruitment and Engagement  

The average Black/African American and Hispanic/Latino research participation rates hover around 11%.⁶ Clinical trials supported by Elligo, however, have a diverse participation rate of at least 26%. Furthermore, our patient dropout rate is only 12.8%, less than half of the industry average.⁷ To put it simply, our methods work.  

FDORA has already had an impact on research diversity. With Elligo’s help, you can, too. Contact us today to get started.  

References  

1. Consolidated Appropriations Act, 2023. Congress.gov. Accessed 2023 Feb. 17.  
2. H. R. 2617. Authenticated U.S. Government Information GPO. Accessed 2023 Feb. 17.  
3. Andrulis, D.P., et al. Integrating Literacy, Culture, and Language to Improve Health Care Quality for Diverse Populations. Am J Health Behav. Published 2007 Sep-Oct.  
4. United States Census Bureau – Detailed languages spoken at home and ability to speak English for the population 5 years and over: 2022. Accessed 2024 March.  
5. Igwe, J.K., et al. Opportunities to Increase Science of Diversity and Inclusion in Clinical Trials: Equity and a Lack of a Control. Journal of the American Heart Association. Published 2023 Dec. 18. 
6. Flores, L., et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Network. Published 2021 Feb. 19. 
7. Alexander, W. The Uphill Path to Successful Clinical Trials. P&T. Published 2023 April.