Ethics and Equity in Clinical Trials & FDA Diversity Guidance Prep

A Path to Inclusive Healthcare

Clinical trials serve as the bedrock for advancements in medicine, guiding the development of new treatments and therapies. However, a critical issue plaguing these trials is the lack of diversity among participants, particularly from underrepresented racial and ethnic populations and medically underserved communities. In this blog, we uncover the latest strategies for crafting equity in clinical trials so that they not only fulfill scientific needs but champion diversity and inclusivity, paving the way for a more equitable healthcare future.

The Role of Social Determinants of Health and FDA Diversity Guidance

The FDA is beginning to broaden its perspective, considering not just race and sex but also other aspects of diversity, such as disability status and mental illness, among other metrics beyond race and ethnicity. Social Determinants of Health (SDOH) are also being recognized as pivotal in understanding clinical trial diversity and identifying ways to enhance it. SDOH includes factors like socioeconomic status, access to healthcare, education, and environment, which greatly influence health outcomes. Factoring in these elements and grasping their influence on the quality and completeness of data collected during clinical research is essential for creating inclusive trials.

During our live webinar with FirstWord, industry representatives from CROs, Sponsors, Technology Companies, and Sites shared their insights. Watch the full webinar.

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Building Clinical Trial Diversity Requires Access to the Right Data

Ensuring access to the right data is key to building inclusive clinical trials. To achieve an inclusive healthcare ecosystem, it is essential to examine the entire clinical trial process through the lens of the data being utilized. Access to comprehensive data is indispensable; it is the foundation for creating trials that reflect a wide array of patient demographics and health realities. It’s important to evaluate the current data you rely on and ask, “Does it encompass all necessary metrics, or does it exhibit significant gaps that could hinder inclusivity?”

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Source: Insights from our FirstWord webinar: CROs, Sponsors, Tech, Sites

Building Diverse and Tech-enabled Trials

Navigating the development of Diversity and Equity Inclusion (DEI) plans demands a careful evaluation of technology. In this section, we’ll explore the key steps involved in choosing the right tools and data to empower these crucial initiatives.

plum magnifying glass icon1. Perform a gap analysis

When evaluating technology to support the development of DEI plans to align with FDA diversity guidance, it’s best to begin the process with a comprehensive gap analysis to identify what resources are already accessible and where the gaps lie. This analysis helps ensure efficient resource allocation toward the needs.

data icon in plum2. Examine potential data providers

Key considerations include their access to comprehensive claims data, patient counts for benchmarking, and insights beyond basic demographics, including social determinants of health to improve patient engagement strategies. Additionally, assess if data partners offer information on healthcare provider diversity and language capabilities, which are crucial for establishing authentic connections with target patient populations and building trust for more inclusive healthcare.

plum map icon3. Evaluate data by geographical need

It is essential to confirm that the data comprehensively aligns with your organization’s specific geography needs. To effectively implement health equity strategies, one must consider the global trial needs to be informed by localized data. This includes assuring that the geographic coverage provided by the data is in sync with the areas where your company aims to focus its efforts in supporting patients and investigative sites. This step ensures that your initiatives and strategies are rooted in relevant and actionable insights, ultimately enhancing the impact of your efforts in your targeted regions.


Achieving diversity and equity in clinical trials transcends mere compliance—it’s a moral obligation. Addressing social determinants of health and harnessing the right data and technology are key to empowering research that reflects true patient diversity and promotes equitable healthcare. With Trial Landscape, you gain unparalleled access to the most comprehensive pool of investigator and site insights, alongside clinical trial performance data and benchmarks. Explore how Trial Landscape is uniquely positioned to empower you with the insights needed to launch diverse and successful clinical trials.

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