Clinical Trial Diversity Hub

Diversity in clinical trials is more than just a box to check off in relation to an organization’s diversity, equity, and inclusion (DEI) practices. Minorities should be included in studies because their symptoms, reactions to medications, and even physiology are different. One-fifth of new drugs approved between 2008 and 2013 showed racial differences in drug response that were, in some cases, significant enough to impact prescribing decisions.¹

FDA & Other Guidance on Diversity Action Plans

US Food and Drug Administration (FDA) Diversity Action Plans are required for Phase III and other pivotal clinical studies. Here’s a deep dive into diversity regulations.

FDA Diversity Action Plans: Decipering the Guidance and its Consequences

Regulatory & Compliance

FDA Diversity Action Plans: Decipering the Guidance and its Consequences

In this Vistatec webinar, Citeline’s Lya Rebelow, along with Joan Chambers and Aman Khera, share their insights on the long-awaited updated guidance on diversity action plans.

Regulatory & Compliance

What US FDA Is Expecting and When

See what the US FDA is expecting from diversity action plans and when this might be implemented.

Regulatory & Compliance

Former Surgeon General on Why US Government Should Push Trial Diversity

Former US Surgeon General Jerome Adams says now is the time for smart, thoughtful regulation that will hold industry accountable for clinical trial diversity.

Regulatory & Compliance

Looking Back, Looking Forward: FDA Diversity Action Plans

The FDA's updated guidance on diversity action plans aims to improve the enrollment of underrepresented populations in clinical trials. Strengthened by FDORA, it now includes requirements for diversity in age, sex, and other characteristics.

Regulatory & Compliance

Clinical Trial Diversity Action Plans Will Take 100 Hours to Prepare

Drug and biologic product sponsors will spend on average 100 hours to prepare and submit each clinical trial diversity action plan required under a 2022 law, the FDA estimates.

Regulatory & Compliance

Will US Clinical Study Diversity Guidance Cloud Chinese Firms’ Prospects for Going Global?

The latest FDA diversity guidance will have profound impact to Chinese biotech sector at a time when going global and a US approval is vital to its very survival.

Hands of different ethnicities stacked on top of each other.

Regulatory & Compliance

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

New draft guidance strongly encourages sponsors to publicly share diversity action plans and enrollment goals, potentially enforcing compliance de facto.

Overflowing cup of coffee.

Regulatory & Compliance

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need to Overenroll Key Groups

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.

Regulatory & Compliance

Drug Fix: What's In and Out of US FDA's Diversity Action Plan Guidance, AI Guidance Also Coming

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.

Patients in a waiting room with healthcare professionals.

Deciphering the FDA Diversity Plan Updated Guidance

On June 26, the FDA released updated guidance on diversity action plans. See what the guidance means for clinical trial sponsors.

Trial Diversity from a Disclosure Perspective

Regulatory & Compliance

Trial Diversity from a Disclosure Perspective

At Citeline’s TrialScope EXTRA event, this session focused on clinical trial diversity from FDA action plans and the perspective of disclosure compliance.

Watch Navigating the Maze of Diversity in Clinical Trials on demand webinar.

Navigating the Maze of Diversity in Clinical Trials

This informative webinar delves into the complexities and nuances of the latest FDA guidances on collecting race and ethnicity data in clinical trials.

Group of people collaborating around a table.

Top 5 Insights from FDA Public Workshop to Enhance Clinical Trial Diversity

Top insights from a clinical trial diversity workshop conducted by the US Food and Drug Administration and the Clinical Trials Transformation Initiative.

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Regulatory & Compliance

UK Trial Inclusion and Diversity Plans to Have ‘Wider Scope’ Than Those in US

The UK’s proposed approach to requiring clinical trial diversity plans will go beyond those in place in the US.

Diversity & Clinical Planning

Sponsors that make diversity in research a priority do not regard it as an afterthought; they make it part of their clinical strategy, starting with protocol design.

A female scientist in a lab coat holds a tube, conducting experiments in a laboratory setting.

Diversity at the Start: Best Practices for Clinical Trial Planning

Study sponsors should begin their clinical trial diversity efforts with a fit-for-purpose clinical protocol.

A diverse group of people looking up.

3 Ways Clinical Trial Diversity Can Put Sponsors On Top

Since the FDA’s draft guidance in 2022, the industry has redoubled its efforts to incorporate diversity at pivotal points in the clinical trial process.

Diversity Challenges… and How to Overcome Them

Clinical trial diversity is filled with inherent challenges. See how study sponsors are addressing these challenges head on.

A group of people from diverse background standing together

Diversity in Clinical Trials: Walking the Walk

Ensuring diversity in clinical trials is not just about talking the talk, it’s about walking the walk.

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Clinical Trial Diversity on a Global Scale

Reporting clinical trial racial and ethnic data is a crucial step toward clinical trial diversity. But these definitions can be different across countries.

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Diversity in Clinical Trials: How Companies Are Tackling the Issue

When it comes to clinical trial diversity, life sciences companies are taking steps to move the needle in the right direction.

Patient Engagement & Recruitment

Accelerating Diversity Enrollment in a Phase III Covid-19 Trial

Citeline Connect helps sponsor reach diversity and inclusion goals

Data: Key to Unlocking Trial Diversity

Pharma faces a Catch-22 situation: Sponsors need demographic data in order to make clinical trials more diverse, but they also need to disclose the data upfront.

Man exploring options for a diverse clinical trial.

Practical Approaches to Clinical Trial Diversity

Learn best practices in increasing diversity in clinical trials and meeting new US FDA requirements for clinical diversity plans.

Clinical Connection Digital Week

Clinical Connection Digital Week Industry insights and expert perspectives

Join Citeline as we delve into topics that are top of mind among clinical trial professionals.

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The Need for Better Diversity Data in Clinical Trial Benchmarking and Feasibility

Just as marginalized patients face barriers to clinical trial participation, study sponsors face challenges in obtaining clinical trial diversity data.

LGBTQIA+ Diversity in Clinical Trials

It’s up to sponsors to smooth the LGBTQIA+ patient journey for clinical trials, starting with gender-neutral protocols and making trial communication more inclusive.

Deepening Diversity: LGBTQIA+ Diversity in Clinical Research

Expert panelists discuss how sponsors can smooth the LGBTQIA+ patient journey for clinical trials, starting with gender-neutral protocols, making trial communication more inclusive, the FDA’s draft guidance on diversity plans and data collection, and the roles that sites/investigators can play.

A takeaway box, similar to those used in Chinese restaurants.

SCOPE 2024: Key takeaways from a first-time attendee

The Summit for Clinops Executives (SCOPE) was filled with informative sessions. Here are few key takeaways from SCOPE 2024: the importance of quality data, rethinking diversity in clinical trials, patient-centricity, and more.

Straight Ally flag waving in the wind at cloudy sky.

Diversified Approach Needed for LGBTQIA+ Inclusion in Clinical Trials

Overcoming barriers to LGBTQIA+ participation in clinical trials requires a diversified approach, including staff training, recognizing intersectionality, community outreach and more.

Boost Diversity with Citeline Solutions & Insights

See how Citeline solutions, services, and insights can help your organization move the needle on diversity in clinical trials.

Global Patient Insights

The industry’s most comprehensive view of the worldwide patient landscape. This robust dataset enables study sponsors to select the best possible geographic locations, sites, and investigators for their clinical trials.

Thumbnail of the Supporting Diversity in Clinical Trial Recruitment Infographic PDF.

Patient Engagement & Recruitment

Supporting Diversity in Clinical Trial Recruitment

See how the Citeline Connect Recruitment Collective partnership network drives study awareness and participation globally.

Regulatory & Compliance

If you need to understand – and anticipate – the policy and regulatory developments critical to success in these areas, you need Pink Sheet - the world's premier source of regulatory insights that impact strategic business decisions.

Additional Resources

We’ve curated a selection of content to help you promote diversity in clinical trials both within your organization and in the industry as a whole.

CISCRP brochure

CISCRP: Downloadable Brochures on Clinical Trials for a Variety of Patient Communities

Norstella: Eight routes to patient diversity

Boston Globe: The need for clinical trial diversity: How we got here and where we’re headed

Boston Globe: Diversity and decentralization will be cornerstones of post-COVID clinical trial design

MCRT Center: Achieving Diversity, Inclusion, and Equity IN Clinical Research Toolkit

Fenway Health: The Nuts and Bolts of SOGI Data Implementation: A Troubleshooting Toolkit

¹ Racial/ethnic differences in drug disposition and response: review of recently approved drugs - PubMed (nih.gov)