Diversity and Inclusion in Clinical Trials

UPDATED FDA GUIDANCE
Supporting Diversity Action Plans

Create and write a robust Diversity Action Plan with our experienced team to ensure your program includes diversity demographic targets that reflect the population to which your product will be prescribed in the real world.

Support negotiation with regulators for concurrence on your Diversity Action Plan.

Enable in-study monitoring to observe trends and dynamically adjust your enrollment strategies with our proprietary platform.

Work with an experienced partner that’s invested in your diversity goals.

The U.S. FDA continues to intensify its focus on improving diversity in clinical trials. On June 26, 2024, the long-awaited draft guidance was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance is now open for comments through September 26, 2024. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.

“Since July 2023, we have been helping sponsors prepare their Diversity Action Plans and have worked on 37 plans so far. We have been actively gathering the FDA’s feedback to better prepare for studies that will start once approval of a Diversity Action Plan before initiation of pivotal studies is mandated,” said Beatriz Rocha, MD, PhD, Chief Regulatory Liaison Officer at Fortrea. “The new guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans. In addition, the guidance describes the criteria and process by which the FDA will evaluate sponsors’ requests for waivers, and those who may wish to publicly post key information regarding their Diversity Action Plans.”

The Fortrea Regulatory Strategy Consulting team continues to closely track the U.S. regulatory landscape to understand how other regulatory agencies (such as the European Medicines Agency [EMA] and Medicines & Healthcare products Regulatory Agency [MHRA]) are working to meaningfully improve the diversity of clinical trial participants in global studies. Together, we can help you meet legal requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.

Let's Start a Conversation

Get support for your Diversity Action Plan.

At Fortrea, we are committed to writing and supporting the implementation of Diversity Action Plans that will set diversity goals and help eliminate gaps in participation. Throughout your clinical development, we act as an extension of your team to support your diversity goals and inclusion practices in clinical trials. With our unique combination of consulting services, mobile and digital capabilities and our innovative Diversity and Inclusion Insights Dashboard, we’re ready to enable greater patient access and improve healthcare for all.

Get the latest updates from our team.

We’re sharing our latest news, events and publications.

White Paper

Improving access in diverse communities for clinical trial participation.

Read the white paper

BLOG ARTICLE

Diversity Action Plans: What sponsors need to know about the latest FDA guidance

Read the blog article

Let’s reflect diversity throughout your clinical development.

To comply with regulations and meet requirements for diverse representation in clinical trials, we offer an integrated five-part process that encompasses Diversity Action Plan writing, regulatory submission and negotiations, implementation and in-study diversity monitoring through our proprietary platform to track your program's progress.

Researching real-world data to inform diversity planning.

Diversity planning begins with a thorough epidemiology assessment to determine the prevalence of the disease in the target patient population utilizing real-world data (RWD) and literature. As part of informing your Diversity Action Plan, our experts provide consultation to understand the requirements, applicability to your program and map out a path forward. Starting with this research, we work with you to understand the data and set realistic diversity goals.

Providing dynamic preparation of your Diversity Action Plan.

Your Diversity Action Plan is a multi-functional document. We serve as an extension of your team and work with subject matter experts from across our organization to prepare and write your Diversity Action Plan. After your plan is submitted, we negotiate with regulators on your behalf.

Implementing your Diversity Action Plan.

With access to multiple data platforms, our Site Advisory Board and technology-enabled solutions, our team at Fortrea identifies where the target diverse patients are located and implements strategies to attract and retain them.

Monitoring enrollment diversity and end-of-study reporting.

Track progress toward your study diversity goals with our proprietary platform: The Fortrea Diversity and Inclusion Study Insights Dashboard. Our library of visualizations can track relevant demographics, focus on specific screen failure rates and assess the safety and effectiveness of the study drug, based on key parameter profiles of the subjects enrolled.

Supporting regulatory interactions.

Your Diversity Action Plan is a living document. Throughout a study and a program, we continue to gather metrics, write reports and support your discussions with regulators, as needed.

Leverage powerful, in-study diversity insights.

The Fortrea Diversity and Inclusion Study Insights Dashboard

To help ensure your study is reflective of a real-world population, we can provide in-study monitoring of the predefined demographic and non-demographic characteristics to monitor the enrollment of participants.

From study start-up through conduct and close-out, our proprietary dashboard can:

Analyze data by race, age, sex and ethnicity to assist with the identification of population-specific signals
Enable the assessment of the safety and effectiveness of the study drug based on key parameter profiles of the subjects enrolled
Review any subject withdrawals and those lost to follow-up cases across different cohorts/sites to refine your retention strategy

With powerful, in-study diversity data from the Fortrea Diversity and Inclusion Study Insights Dashboard, you’ll have an on-hand view of current trends in your trial so you can:

Make informed decisions to assess the impact of your Diversity Action Plan
Adjust your enrollment and retention strategies
Implement corrective actions
Generate reports to support ongoing regulatory engagement and filing

Throughout your clinical development, we act as an extension of your team to support your diversity and inclusion practices.

Together, let’s advance our shared goals to deliver more meaningful clinical research.

Let's start a conversation

Your needs. Our solutions.

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.