BRIDGING THE GAP: HOW THE NEW FDA DRAFT GUIDANCE ON DIVERSITY ACTION PLANS WILL IMPROVE CLINICAL TRIAL DESIGNS

The FDA’s new draft guidance¹ on diversity action plans was released in June 2024, highlighting the urgent need to improve demographic diversity in clinical trials. This initiative is particularly important because certain racial and ethnic groups often bear a disproportionate burden of disease. For instance, between 2008 and 2018, the percentage of African American participants in pivotal cancer drug trials increased marginally from 2.9% to only 3.6%². This is particularly concerning since African Americans account for approximately 13% of the U.S. population³, and for most cancers have the highest mortality rates and shortest survival times⁴.

To address these disparities, in June 2022, the U.S. House of Representatives passed the Diverse and Equitable Participation in Clinical Trials Act. This law requires study sponsors to develop action plans for including diverse populations in all phase 3 trials and other pivotal trials. This marks a significant step forward. But, how could clinical trial designs evolve to achieve these diversity goals?

• Early Planning: Setting clear objectives for minority inclusion should be prioritized from the study’s inception, ensuring diversity in clinical trials by design.
• Broadened Eligibility: Eligibility criteria need to be reassessed, particularly regarding factors like age and comorbidities, which often disproportionately affect vulnerable populations.
• Decentralized Approaches: Reducing patient burden by utilizing remote monitoring and telemedicine to make participation more accessible for individuals from underrepresented communities.
• Transparent Reporting: Anonymized data on participants’ race, ethnicity, age, and gender should be openly shared to assess how treatments perform across diverse groups.
• Community Engagement: Building partnerships with community leaders and representatives is vital for fostering trust and using their insights to design studies that encourage participation from all backgrounds.
• Adaptive Enrollment: Trials should adopt flexible recruitment strategies, allowing adjustments during the enrollment process to overcome emerging barriers.
• Patient-Centric Communication: Information provided to patients, including informed consent, should be relevant, engaging, and comprehensible to empower decision-making based on a clear understanding of the risks and benefits of participating in a clinical trial.
• Digitalization and Standardization of Study Designs: Enabling more effective analysis of clinical data across studies, leading to: 1) better insights into patient burden, and 2) a greater understanding of how trial designs impact participant diversity.

Nurocor leads the way in pioneering technology platforms to inform and digitalize study designs, helping sponsors to expedite the delivery of medicines and vaccines to those who need them most.

Contact us to discover how Nurocor’s digital study design solutions can support your clinical trials.

This blog was developed using the Nurocor Authoring Application.

REFERENCES 

1. FDA:Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. Draft Guidance for Industry; June 2024;  Available At: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies
2. Loree JM, Anand S, Dasari A, Unger JM, Gothwal A, Ellis LM, Varadhachary G, Kopetz S, Overman MJ, Raghav K: Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol.2019 Oct 1;5(10):e191870. DOI: 10.1001/jamaoncol.2019.1870.
3. Warren Rueben C, Forrow Lachlan, Hodge David Augustin, Truog Robert D:Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community. The New England Journal of Medicine. 26Nov.2020;383(22)e121. DOI: 10.1056/NEJMp2030033.
4. American Cancer Society:Cancer Facts & Figures for African American/Black People. 2024; Available At: https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html