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FDA Guidance for Diversity in Clinical Trials: What You Need to Know

Drawing of diverse patients standing together

The FDA’s newest guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” took the clinical research world by storm. 

While diversity, equity, and inclusion have been major focuses for clinical research teams for a long time, sponsors and sites were excited and surprised to receive explicit FDA guidance in April 2022. 

But what do clinical research teams need to know from the guidance, and how can we prepare to incorporate it? We invited Catherine Gregor, Chief Clinical Trial Officer at Florence and former Director of Clinical Research Administration at Vanderbilt-Ingram Cancer Center, to help us break down the guidance in a webinar

This article combines insights from the webinar with notable sections straight from the FDA guidance for diversity in clinical trials. Keep reading to discover how you can help your clinical research organization follow FDA standards while creating more inclusive trials. 

This post is intended as guidance for the FDA diversity standards, not as legally binding regulations. For in-depth compliance information, please contact a member of our compliance team at info@florencehc.com.

What is the goal of the FDA guidance for diversity? 

The FDA guidance focuses on racial and ethnic inclusion, especially the inclusion of “underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islander, and other persons of color” (Sec 1). 

Catherine Gregor pointed out that this guidance doesn’t cover all forms of diversity: clinical trial sites should also think about inclusion for LGBTQ+, elderly, and disabled patients. But the FDA focused on racial and ethnic diversity because it’s such a pressing need. 

Approximately 20% of drugs have different effects depending on a patient’s race. As the FDA puts it, we must “ensure drugs work and are safe for all those who may use them,” and to do that, we need diverse trials.

But so far, clinical trials have fallen short of this goal:

So the FDA set out to create guidance to increase racial diversity. The result was asking clinical trial sponsors and investigators to create a Race and Ethnicity Diversity Plan.

What is a Race and Ethnicity Diversity Plan? 

A Race and Ethnicity Plan is “a Plan to enroll representative numbers of participants from historically underrepresented racial and ethnic populations” (Sec II). 

A sponsor must send this plan to the FDA when they submit (Sec III):

  • An Investigational New Drug (IND) Application
  • A drug marketing submission
  • An Investigational Device Exemption (IDE) Application or
  • A device marketing submission

The plan should be submitted and discussed with the FDA as soon as possible, but no later than the End of Phase 2 (EOP2) meeting (Sec IV). 

Catherine Gregor emphasizes that sponsors and investigators should talk to the FDA about whether their plan will produce diverse trials. Sites should also ask their sponsors or CROs for help to meet these goals.

What should a Race and Ethnicity Diversity Plan include? 

The FDA says that a Race and Ethnicity Diversity Plan should include (Sec V)

  • Overview of the disease/condition 
      1. Representation of the disease among underrepresented racial and ethnic groups 
      2. Pre-existing evidence on whether the disease or its treatment varies based on race or ethnicity
  • Scope of medical product development program
      1. The planned trials that will support the medical product’s safety, effectiveness, and dosage, including
        1. Study design and population, eligibility criteria, endpoints, geographic location, and how this will impact divesity
      2. Any findings from pharmacology studies that indicate different effects based on race or ethnicity
  • Goals for enrollment of underrepresented racial and ethnic participants
      1. Explain the planned enrollment goals for patients from different racial and ethnic groups
  • A specific plan of action to enroll and retain diverse participants
      1. The actions you’ll take to enroll underrepresented racial and ethnic populations. These could include:
        1. Thinking about site location and access (e.g., engaging community-based sites
        2. Sustaining community engagement (e.g., community advisory boards)
        3. Reducing burdens due to trial/study design/conduct (e.g., number of visits) 
        4. Describing diversity metrics and actions to take if those goals are not being met
  • Status of meeting enrollment goals
      1. As the diversity plan is updated, discuss the status of meeting enrollment goals. If the sponsor is not able to achieve the enrollment goals despite their best efforts, discuss a plan for collecting data post-marketing. 

But as many sites and sponsors on our webinar pointed out, saying you’ll create a diversity plan is easy–knowing what to put in that plan is hard.

How to Increase Racial Diversity in Clinical Trials

There’s no guaranteed way to increase inclusion in clinical trials. But Catherine Gregor noted three areas clinical trial teams can focus on that may improve inclusion in clinical research: 

  1. Increase trust lost by historical abuses
  2. Re-examine inclusion and exclusion criteria
  3. Expand trials to more sites

Here are ways sites and sponsors can increase diversity throughout clinical trials.

1. Increase trust lost by historical abuses

The exploitation of the African American men in the Tuskegee syphilis study, the theft of Henrietta Lacks’s cells, and other historical abuses have caused many people of color to understandably distrust clinical research. 

A few statistics about trust in clinical trials: 

The good news? 81% of Latinx patients and 74% of Black patients said they would be willing to participate in a clinical trial if their doctor recommended one to them. By involving more physicians, especially physicians from underrepresented groups, we have a good chance of building trust with patients.

In our webinar, Catherine Gregor also offered a few other strategies for building trust:

  • Bringing patients to the table during the design and planning of studies
  • Going into underserved communities to talk about clinical trials and their benefits
  • Creating internal Diversity, Equity, and Inclusion committees to increase the diversity of investigators, Clinical Research Coordinators, and Clinical Research Associates

2. Re-examine inclusion and exclusion criteria

One of the most efficient ways to increase clinical trial diversity is for investigators and sponsors to reexamine their study inclusion and exclusion criteria. 

In the past, patients have often been excluded based on:

  • Age
  • Body Mass Index (BMI)
  • Chronic illnesses and disabilities

Some of these exclusions are justified by the need to protect patients. But as Catherine Gregor explained, sometimes sites and sponsors exclude patients because they’ve always excluded them, without examining why. 

In one review, 84% of studies didn’t explain or poorly explained why they’d excluded patients with disabilities, making it impossible to tell if the exclusion was justified. 

By looking critically at inclusion and exclusion criteria, investigators and sponsors can open new studies and cutting-edge treatments to a wider range of patients.

3. Expand trials to more sites

Historically, large academic medical centers or cancer centers have hosted most clinical trials. That meant only patients who lived nearby or who could afford to travel had access to studies. 

To increase diversity, sponsors need to “go into the community and engage with trusted partners in neighborhoods where patients live,” said Catherine Gregor. 

Using Technology to Reach Diverse Patients

Reducing barriers to clinical trial participation can take a variety of forms. Some patients may like to cut down on the number of site visits by using technology like:

  • eConsent
  • Wearables
  • eDiaries
  • Telehealth

Patients who are older or disabled, work strict hours, or rely on public transportation could participate in clinical trials more easily if they had to visit the site less often. 

For example, eConsent lets patients fill out consent forms, review them with their family, and submit them from home without having to make an additional visit to the office. They can just consent from their phone or computer. The FDA has even explicitly expressed approval of eConsent.

Many patients may also like to use wearable devices, eDiaries, and telehealth calls to submit data on their weight, blood pressure, or heart rate from home. This saves them from having to travel to the site just for a quick check-in. 

However, technology comes with additional barriers:

  • Sites must ensure technology is user-friendly so patients feel confident using it at home.
  • Sites must also provide Internet access and devices to patients who may not have them.

Low-income patients are less likely to have WiFi access, and if sites don’t account for this discrepancy, they could end up lessening diversity instead of increasing it.

Bringing Trials to Local Sites

Bringing clinical trials to community sites, like pharmacies, doctors’ offices, and health clinics, can give new, diverse populations access to clinical trials. 

Some trials, such as cancer trials, simply can’t take place at home. And some patients aren’t comfortable with or don’t have access to technology. When larger sites and academic medical centers partner with local sites, they give participants the chance to engage with trials in their own neighborhoods. 

Participants can quickly have their blood drawn, get their blood pressure checked, or pick up medication from their local pharmacy without needing to miss work or travel long distances.

Whether large sites and sponsors decide to work with patient-facing technology or with local sites, the goal remains the same: make trials accessible to patients who’ve never had access to them before. That’s why Catherine Gregor emphasized in our webinar that, above all, sites must listen to what diverse patients are asking for and adapt based on patient needs.

Carrying Out the FDA Guidance for Diversity in Clinical Trials

Most sites, sponsors, and CROs want to increase the diversity of their clinical trials. They realize that greater inclusion leads to more accurate trial results and better treatments for all of the patients who need them. 

That’s why so many clinical trial teams eagerly welcomed the FDA’s guidance on clinical trial diversity. The guidelines encourage investigators and sponsors to create a Race and Ethnicity Diversity Plan and says what should be included in that plan. 

Sites and sponsors now know they need to: 

  • Explain their specific diversity goals
  • Justify why they chose those goals based on the disease they’re treating
  • Describe how they plan to reach those goals

But the FDA still gives investigators and sponsors a great deal of freedom in determining what methods will help them reach their diversity goals, and that freedom can be overwhelming. Technology, trust-building with community leaders, and reaching out to neighborhood sites all play essential roles in increasing access, diversity, and inclusion.

For more on how you can follow the FDA’s clinical trial diversity standards, check out the full recording of our webinar with Catherine Gregor. She shares invaluable tips from her years of experience in multiple therapeutic areas across both academic and community sites, including her time at Florence and Vanderbilt-Ingram Cancer Center. 

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