New FDA Regulations for Diversity and Inclusion in Clinical Trials for 2024

What the new FDA regulations mean for upcoming clinical trials, and how you can utilize tools to navigate the new environment

Photo portrait of Marnie Willman, BSc
Marnie Willman, BSc

Marnie Willman, BSc, is Today’s Clinical Lab’s creative services writer/editor. Marnie obtained her BSc from Vancouver Island University and is currently completing her PhD in medical microbiology and infectious diseases at the University of Manitoba. Her doctoral dissertation was focused on the discovery of novel therapeutics for influenza A virus, during which time she also worked as a freelance science writer. Her work has been published in Viruses, iScience, Journal of Virology, Massive Science, The Wire, ASBMB Today, Salon, and MyHealthTeams.

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Published:Oct 17, 2023
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In April 2022, the FDA announced that as of 2024, there were new Diversity and Inclusion guidances for clinical trials. Commissioner Robert M. Cliff stated in a press release that “going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.” However, higher requirements pose a problem for research groups designing clinical trials, which now must employ more in-depth Diversity and Inclusion planning teams to meet these stringent conditions required to remain FDA compliant. However, there are tools, and more specifically, toolkits that can be applied to help clinical trial staff meet these high requirements. 

The importance of representation in clinical trials

Ensuring that the population studied for a clinical trial accurately represents the population actually affected by the condition is vital for interpretation of results. To generate a successful clinical trial, a match between the clinical trial population and condition-affected population is essential. But strategies that are effective at identifying, finding, and enrolling this population are not universal. Particularly in the case of underserved and underrepresented groups, a variety of accessibility barriers can hinder the desired clinical trial representation. For example, ethnic minorities can face language barriers and poverty can reduce an individual’s ability to reach a clinical site due to lack of a vehicle. At multiple stages of the clinical trial, barriers to representation and accessibility must be assessed. 

When diversity and inclusion must be taken into account

There is a common misconception that the only time when diversity and inclusion must be taken into account is during the initial, planning phases of a clinical trial. However, there are actually several key areas when diversity and inclusion need to be accounted for including throughout the trial to ensure participant dropout and other alterations throughout do not affect representation overall. In addition to preliminary assessments for representation, continuous assessment of diversity and inclusion rates throughout the trial are needed. These assessments can require extensive resources in terms of time and financial allocations for a clinical research team. 

The inclusivity, diversity, and equity in action toolkit

Curavit Clinical Research has recently released their new Inclusivity, Diversity, and Equity in Action (IDEA) toolkit to answer this need of developing and managing diversity action plans. The IDEA toolkit delivers support across five areas during a clinical trial:

  1. Preliminary situational analysis
  2. DEI implementation strategy
  3. Content review
  4. Continuous check-ins
  5. Ongoing optimization

The toolkit includes planning templates to ensure important underrepresented patient populations are included in the clinical trial. IDEA also details how to compile effective strategies to recruit diverse groups of patients for enrollment and identify potential areas where investigators can seek and identify their desired patient populations

Together, tools like IDEA let clinical trial researchers focus on important aspects of a clinical trial without the concern that they have not accurately represented the population affected by the condition being studied. Using the toolkit shows a clinical trial research team when to assess representation and provides templates to provide guidance for reassessing diversity and inclusion criteria and metrics for their clinical trial. Say goodbye to the risk of poor representation by using technology-driven toolkits to plan clinical trials to meet the new mandatory representation guidelines for 2024. 


Marnie Willman, BSc
Marnie Willman, BSc

Marnie Willman, BSc, is Today’s Clinical Lab’s creative services writer/editor. Marnie obtained her BSc from Vancouver Island University and is currently completing her PhD in medical microbiology and infectious diseases at the University of Manitoba. Her doctoral dissertation was focused on the discovery of novel therapeutics for influenza A virus, during which time she also worked as a freelance science writer. Her work has been published in Viruses, iScience, Journal of Virology, Massive Science, The Wire, ASBMB Today, Salon, and MyHealthTeams.


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Clinical TrialsMedical ResearchManagementdiversityclinical research
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Curavit Clinical Research has released an Inclusivity, Diversity, and Equity in Action (IDEA) toolkit to help clinical trial staff develop and manage diversity action plans.
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