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FDA Guidance on Inclusion and Diversity

Clinical Trial Management

Strategies for Inclusion and Diversity in Clinical Trials: Aligning with FDA’s Latest Guidance

In an effort to enhance racial and ethnic diversity in clinical trials, the FDA is moving in step with the Biden Administration’s Cancer Moonshot Goal of improving the lives of people with cancer, which includes addressing inequities in clinical research. New draft guidance has been released by the FDA to encourage increased enrollment of underrepresented racial and ethnic populations in U.S. clinical trials. 

FDA’s Recommendations to Support Diverse Populations

The FDA’s guidance, titled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials”, provides recommendations to sponsors in the development of a Race and Ethnicity Diversity Plan. The aim of this plan is to enroll adequate numbers of underrepresented racial and ethnic populations in U.S. clinical trials. This document expands on the FDA’s previous guidance from October 2016, “Collection of Race and Ethnicity Data in Clinical Trials”, outlining how to collect and present race and ethnicity data in FDA submissions.

Importance of Inclusion in Clinical Trials 

While racial and ethnic minorities face a higher disease burden, they are often underrepresented in biomedical research, impacting the validity of clinical trial findings. Clinical trial enrollment should mirror the population’s diversity to ensure the effectiveness and safety of medical products.

Biological differences and variations in genetics influence how people respond to certain therapies. These differences make drugs like antidepressants and blood-pressure medications less effective or safe for certain ethnic or racial groups.

Improving Diversity Through Digital Trials

Hybrid and Decentralized Clinical Trials (DCTs) stand at the forefront of inclusion and diversity in clinical research, regardless of trial complexity, scale or integrations. Here’s how:

Expanding Reach
Digital trials can easily boost patient accessibility by allowing for a wider, more varied participant base. These trials lessen the burden on investigators by offering remote screening, direct-to-patient product shipments, and telehealth consultations.

Bypassing Geographic Barriers 
Fully remote trials have the capacity to eliminate geographic limitations that often deter diverse populations from participating. By facilitating participation from any location, DCTs can connect with a larger demographic, thereby increasing the diversity in clinical trials.

Convenience and Accessibility
With the flexibility of remote participation, DCTs can ease caregiver involvement and foster research into rare diseases or conditions that affect individuals with restricted mobility or access to traditional on-site trials.

Bypassing Geographic Barriers
Leveraging community-based organizations aids in reaching a wider population and enhancing diversity in clinical trials. By interacting with patients in their own environment and through healthcare providers they already trust, DCTs can foster greater awareness and credibility among underrepresented communities.

The Vital Role of Digital-ready Clinical Trial Platforms

Conventional platforms often scramble to integrate digital add-on features, creating scalability issues, compromised data, and increased costs. To seamlessly and effectively increase inclusivity in trials, sponsors need purpose-built software to reliably and securely support the unique requirements of remote trials. 

The Alethium Edge

Built as a digital solution from the onset, the Alethium eClinical Platform effortlessly adapts to complex trial needs, eliminating costly, lengthy, and risky customizations. Alethium quickly and safely scales clinical trials across multiple locations and languages.

Learn how Alethium can support your next eClinical trial, maximizing diversity and inclusion. 

Schedule a demo today!