On Oct. 9, 2024, a WCG panel comprised of Emery Brandy, senior manager, client delivery, Olga Balderas, IRB regulatory chair and vice chair, and Amy Thue, associate director, project management, hosted a webinar centering their discussion on the DEI mandate, upcoming trends, and crucial elements needed for IRB and the recruitment process. This blog is a recap of that conversation.

Diversity Action Plan (DAP) Guidance

The Diversity Action Plan (DAP) guidance focuses on increasing enrollment of historically underrepresented populations in clinical studies to enhance the generalizability of evidence for the larger population.

The session began with a discussion of DAP’s goal: making research findings applicable to a broader audience. This initiative involves everyone in the clinical research ecosystem, from pharmaceutical and biotechnology companies to healthcare providers and research site staff.

1. Clinical Studies Requiring DAPs
   DAPs are mandatory for Phase III and other pivotal drug studies. The FDA suggests early submission of these plans, ideally by the end of Phase II.
2. Addressing Diversity in DAPs
   Sponsors are encouraged to leverage demographic registries, surveys, and published literature to inform their enrollment goals. It is also important to consider various diversity factors, including geographic location, disabilities, socioeconomic status, pregnancy, and comorbidities.
3. The Content of the DAP
   The content included in a DAP could be, but is not limited to, enrollment goals, rationales, and measures that sponsors can take to achieve their diversity goals. Specific strategies include community engagement, participant awareness, and improving access by limiting exclusion criteria and selecting diverse sites. The FDA expects submissions to be succinct— around ten pages. Additionally, all information must be available in consumer-friendly language on company websites and linked to recruitment websites.
4. Timelines for DAP Submission
   For drug studies, DAPs must be submitted to the relevant Investigational New Drug (IND) application by the protocol submission date for Phase III studies. For device studies, requirements vary depending on whether the study involves significant or non-significant risk devices. Given the importance of diverse enrollment, full or partial waivers will only be granted in rare instances.

Important Dates

• Sept. 26, 2024: Cutoff for comments submission.
• June 2025: Expected issue date for final guidance.
• December 2025: DAP requirements take effect.

The DEPICT Act

The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act passed in December 2022 by the United States (U.S.) Congress. This legislation holds sponsors accountable for diversity in their trials. If sponsors cannot meet their diversity goals, they must discuss the challenges with the FDA.

Current measures mainly focus on racial and ethnic diversity. Other underrepresented groups, such as LGBTQIA+, older populations, and those with rare diseases, also need more inclusivity.

Improving Diversity in Participant Recruitment and Retention

1. Sustained Community Engagement
   Community outreach increases clinical research awareness and fosters inclusivity. Effective strategies include:
   • Attending Walks and 5Ks: Engaging in local events to build relationships and increase visibility.
   • Putting Up Flyers: Informing the public by placing flyers in key locations.
   • Referral Provider Networking: Partnering with healthcare providers in diverse communities for participant referrals.
2. Study Materials in Native Languages
   Providing materials in multiple languages and including representational imagery fosters inclusion and relatability. Continuous support throughout the consent process ensures participants are well-informed.
3. Reducing Participant Burden
   Participating in clinical trials is often time-consuming and poses challenges for participants, particularly for marginalized communities. Thus, it’s important for clinical research stakeholders to consider steps to reduce the burden of participation. Solutions include
   • Providing Stipends and Reimbursements: Compensating for transportation and incidental costs.
   • Reducing In-Person Visits: Offering remote alternatives where possible.
   • Clear Instructions and Support: Ensuring participants receive comprehensive instructions and have a point of contact for questions.

On the Horizon

WCG is committed to supporting clients, sponsors, and sites in building trust with participants through dedicated engagement, frequent communication, creative study materials, and efficient data management. True recruitment success transcends meeting diversity quotas; it involves serving the community and ensuring that necessary treatments reach those who need them most.

By incorporating these strategies, marginalized populations can be better represented in clinical studies, leading to more inclusive medical treatments. Let’s move beyond numbers, empower communities, and elevate clinical research.

Discover More

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About the Webinar

Are you prepared to meet the Food and Drug Administration’s (FDA) upcoming requirements on Diversity Action Plans for clinical trials? Learn what the new guidance outlines, including the format, content, timing, and process of implementing Diversity Action Plans into clinical trials. Incorporating comprehensive Diversity, Equity, and Inclusion (DEI) strategies into trial planning, design, and execution enhances representation, optimizes health equity, and strengthens site selection, recruitment, and ethical review.

Watch our informational webinar to get ahead of the curve on improving enrollment of participants from underrepresented populations in your studies.

Key Topics:

• Overview of the FDA’s guidance on Diversity Action Plans for clinical trials.
• The impact of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act passed by U.S. Congress.
• Actionable recommendations for sites, sponsors, and CROs to improve DEI implementation.

Watch Part 2 of The DEI Mandate Series!

The DEI Mandate: How to Accelerate Diversity Initiatives with Data Analytics and Planning (Part 2 of 2)

Participant diversity is taking on a new significance for sponsors and CROs following recent Food and Drug Administration (FDA) guidance revisions. Watch our webinar on this important topic to elevate your diversity, equity, and inclusion (DEI) strategies.

The post The DEI Mandate: What’s on the Horizon and What’s Needed for IRB and Recruitment Processes (Part 1 of 2) appeared first on WCG.

The topic of diversity continues to be a focus in the clinical research sphere. As a result, there has been some speculation as to how certain information, such as race and ethnicity data, would ultimately be recorded when reporting to the U.S. Food and Drug Administration (FDA). The Guidance discussed herein titled, “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products” (hereafter FDA Guidance), provides specifics about the minimum expectation in the reporting of minority groups involved in clinical research and highlights recommended best practices for sponsors.

After the January 2024 publication of the FDA Guidance, the Office of Management and Budget (OMB) revised their Statistical Policy Directive No. 15 (Policy Directive 15), which the FDA Guidance uses to describe the racial and ethnic categories. The FDA is in the process of updating their racial and ethnicity categories to match the updated Policy Directive 15, but otherwise the FDA Guidance remains applicable.  

Standardized Terminology and Policy Directive 15

FDA recognizes the practical challenges in achieving the appropriate enrollment of diverse populations in clinical trials. The FDA Guidance introduces new standardized terminology for race and ethnicity to establish that the submissions to FDA report those diverse groups adequately.

Their recommended approach is based on the OMB’s Policy Directive 15, which was developed in accordance with section 4302 of the Affordable Care Act; the Health and Human Services (HHS) Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status; and the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan.¹

OMB’s Policy Directive 15 was initially developed in 1977 to provide consistent data on race and ethnicity.² In early 2023, OMB announced that a formal review of the 1977 Directive would be taking place. In March 2024 the Policy Directive 15 was revised.

A Basis for the Collection of Racial and Ethnic Data

FDA cites instances in which the ethnic or racial background of a clinical trial participant may play a critical role in different responses to a drug or medical device. In particular, genetics, metabolism, skin pigmentation, or even socioeconomic status are factors to take into account when considering efficacy, safety, or pharmacokinetics. In this framework, ethnic or racial background becomes an important data point for researchers.

Of note, in Policy Directive 15, OMB took the stance that the recommended race and ethnicity categories were not scientifically based designations, but instead were categories that describe the sociocultural construct of society. This perspective is particularly powerful as it applies to the resulting categories that FDA recommends for trial sponsors.

Revised OMB Policy Directive 15

On March 29, 2024, revisions to OMB’s Policy Directive 15 were published in the Federal Register.³ A major change in Policy Directive 15 was to eliminate the two-part ethnicity questions previously used to have a combined race and ethnicity question. Policy Directive 15 now uses a single question format, as public comments stated the two-question structure was confusing. However, in response, some commented that the single-question format with a combined race and ethnicity question joined two very different concepts and even implied that Hispanic or Latino is a “race.”

Ultimately, the flaws in the two-question format were noted by the responses provided in the previous decennial census. The 2020 census showed that 43.5 percent of those who self-identified as Hispanic or Latino either did not report a race or were classified as “Some Other Race” alone. Twenty-three million people answered in this manner, so this “non-response” was interpreted as a failure of the question which was not providing options but hindering them.

One additional topic discussed in the revised OMB’s Policy Directive 15 is on the topic of what constitutes “minimum collection of race and ethnicity data.” Part of the concern is that although the more data collected the more value derived, in some cases, the additional burden would outweigh the potential benefits of collecting detailed data. Ultimately, agencies are required to collect the detailed categories described in that Federal Register Notice as a default.

The new set of minimum race and/or ethnicity categories are:

• American Indian or Alaska Native
• Asian
• Black or African American
• Hispanic or Latino
• Middle Eastern or North African
• Native Hawaiian or Pacific Islander
• White

The figure above is from the Federal Register’s revised OMB document. It is an example of how explanatory/write-in boxes and minimum categories can be used together to effectively capture the most details about a person or group. Additionally, there are multiple detailed checkboxes to aid in self-identification.

Anticipated Setbacks

FDA bases most of the logic for their current Guidance on the Policy Directive 15 from 1977. However, challenges continue to remain for sponsors and researchers who find themselves in regions where this basic application of rules just won’t be sufficient. FDA encourages those researchers to reach out to the division of the FDA appropriate for the research they are conducting. The remaining question is: Will this guarantee that race and ethnicity are both adequately captured in a landscape that is becoming increasingly diverse?

FDA has continued to remain consistent in what is communicated to the clinical research community with a goal of race and ethnicity data being more accurately recorded in research. Without an ever-changing standard, the possibility for consistency in how data is collected is more feasible. Furthermore, it is important to remember that accurately capturing this data aims at resolving a bigger issue: the lack of diversity in clinical research at large. If there is work to be done, it principally lies in finding the best method to capture race and ethnicity data accurately, every time, in support of a more inclusive research sphere.

The Greater Problem: Diversity in Clinical Trials and What You Can Do Now

Properly recording diversity in clinical trials will be the product of the enrollment of a diverse group of individuals in research. Its value cannot be forgotten or set aside. However, understanding the goals early on, making sure study teams are supported and guided to correctly collect this information, and verifying it early in the trial’s progression are all recipes for success.

Site staff may be instrumental when attempting to enroll a more diverse group of participants in clinical research. For example, site staff and principal investigators who “look like” the participant and “speak their first language” are likely to bridge the trust gap. Additionally, the incorporation of translated advertisements into common submission materials is also a major step forward for sponsors to allow potential trial participants that do not speak English as a first language to have the same access to clinical trials. Adding sites that are geographically dispersed may have the potential to reach a greater proportion of more racial and ethnic diverse populations. And finally, not forgetting that sponsors can and should reach out to cherished members and leaders of the community to build trust in areas where there may be trust gaps.

Recommended Best Practices for Sponsors

Sponsors are encouraged to plan early and know when it is time to reach out for help from the FDA. In particular, if the sponsor is aiming to collect certain diversity numbers, sponsors must be sure to have a plan in place to collect that data from the onset. If it is known that diversity data will be collected, it must be clear at which point in the process that data will be collected and there must be an intention to collect that data.

On the other hand, it is important for sponsors to empower teams at a site level to collect this diversity information as early in the clinical trial process as is possible. This usually means data collection at pre-screening or screening. To differentiate, “pre-screening” refers to activities that take place prior to obtaining informed consent. These activities take place after a potential participant expresses interest in the study and initial eligibility questions are asked of the participant to determine if they meet the criteria to be enrolled. On the other hand, “screening” refers to activities which take place after obtaining informed consent.

If sponsors track diversity data early in a clinical trial, it is possible to reset the mark if necessary. In particular, if diversity data are being collected at pre-screening or screening and target numbers are not being met, then there is time to modify goals to reach the target diversity numbers. However, waiting until the enrollment period is closed to see if diversity goals are met could be problematic, as there would be no opportunity to correct.

Conclusion

Reaching diversity goals may appear to be a tall order. However, early planning may alleviate the potential for later pressures. Should any issues be anticipated in reaching diversity goals, strategies or materials may be timely modified with the end goal of capturing a more diverse population. Sponsors and sites must remember the value and need for these diverse populations in the first place. The entire rationale behind a more diverse population is to ensure that new drugs or devices are as safe and effective for all of those in our collective society and not just one segment of the population. Sponsors should work together with sites to inspire and empower them in the early recruitment of diverse populations.

References

1. Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products, https://www.fda.gov/media/175746/download; OMB Statistical Policy Directive No. 15, Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (Policy Directive 15) (October 30, 1997), available at https://obamawhitehouse.archives.gov/omb/fedreg_1997standards. HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status (October 31, 2011), available at https://aspe.hhs.gov/reports/hhs-implementation-guidance-datacollection-standards-race-ethnicity-sex-primary-language-disability-0.
2. Flexibilities and Best Practices for Implementing the Office of Management and Budget’s 1997 Standards for Maintaining, Collecting, And Presenting Federal Data on Race and Ethnicity (Statistical Policy Directive No. 15)  https://www.whitehouse.gov/wp-content/uploads/2022/07/Flexibilities-and-Best-Practices-Under-SPD-15.pdf.
3. Revisions to OMB’s Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (March 29, 2024), available at https://www.federalregister.gov/documents/2024/03/29/2024-06469/revisions-to-ombs-statistical-policy-directive-no-15-standards-for-maintaining-collecting-and.

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The Food and Drug Administration (FDA) is not a stranger in its intent to achieve more diversity in clinical trials. The FDA has been involved in evolving legislation which supports greater diversity in clinical trials.  Additionally, the FDA has written numerous Guidances which are further testament to the commitment that the FDA holds in seeing a more diverse clinical trial population.  Notwithstanding, there is work to be done in this sector, and with the introduction of the DEPICT Act in early 2022 and its passage in December 2022, the inclusion of sponsors in the diversity conversation will catalyze further change. Recommendations are provided for the facilitation of the requisites of the DEPICT Act as well as recognition of some of the challenges ahead.

2. The DEPICT Act

In the newest iteration of an attempt to continue to strive for diversity, the DEPICT Act (Diverse and Equitable Participation in Clinical Trials Act) was passed by Congress in December 2022. The intent of the legislation is to provide more precise guidance to drug and device trial sponsors on how to collectively work toward more inclusion of under-represented populations such as racial and ethnic minority populations, and age and gender diversity. The DEPICT Act requires the FDA to require clinical trial sponsors to submit Diversity Action Plans with their protocols for Phase III or other pivotal trials.  The December 2022 law, gives the FDA until December 2023 to define what specifically is to be included in a Diversity Action plan. The legislation states:

• The diversity plan SHALL include:
  • The sponsor’s goals for enrollment in the clinical study;
  • The sponsor’s rationale for such goals;
  • An explanation of how the sponsor intends to meet those goals.

The legislation goes on to describe that the following information “may be” included as it pertains to a rationale for the sponsor’s enrollment goals:

• The prevalence in the United States of the disease or condition for which the drug or device is being investigated in the trial. The prevalence of any particular disease or condition must be broken down into percentages describing race and other characteristics such as age and sex.
• What is known about the disease or condition for which the drug or device is being investigated;
• Any relevant pharmacokinetic or pharmacogenetic data;
• An explanation for how the sponsor intended to meet these diversity inclusion goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel;
• Information about what is known about the patient population for such disease or condition.¹

The legislation leaves open many questions for Sponsors and sites, about the way in which the action plans will be “adjudicated” and how any potential problems will be communicated.

3. Sponsor Responsibility Under the DEPICT Act

The DEPICT Act, will require the FDA to issue regulations that will hold the sponsor accountable for the amount of diversity, or of lack of, in their clinical trial. One very important point taken from the DEPICT Act is the sponsor’s responsibility in cases where the diversity goals set forth by the sponsor are estimated to not be feasible or not reachable. In these cases, the sponsor still has the responsibility to act and needs to communicate why these goals are not feasible. Thus, there is a sense of accountability for plans that are idealistic or unrealistic. Some possible “exceptions” are noted within the text of the legislation, leaving way for some exceptions in cases where the disease or condition being investigated in the clinical trial is rare or where it may be difficult to recruit participants.

Further guidance on the format and content of these “diversity action plans” is to be expected in the future.

4. A Call to Action: How Sites Can Ameliorate Lack of Trust

The following are some simple steps to begin bridging the gap between sites and the patient.

Awareness

On the topic of ameliorating and bridging trust between patients and sites, awareness must first be introduced. Without awareness, it is not possible to even perceive the distrust that is occurring in the community. Understanding the causes of mistrust is pivotal to understanding certain points of view from varying members of the community. It is paramount to recognize the biases and inequities which were brought upon certain minority communities. This will inform where attention is needed and how to improve.

Prejudices

Examining persisting prejudices is an important step. One study² describes that physicians may have unconscious biases which can unfortunately affect doctor-patient communication and medical care.

Incorporation

If researchers are eager to enroll more diverse populations, it would be wonderful to have already made contact and be engaged in that community. Finding organizations such as churches, and other groups that are community-centered and community builders will enhance the approach to find a way into the community in which researchers are trying to bridge the gap.

Transparency

During discussions with a physician, it is important to remain transparent and be forthcoming with information that may be of great importance to that community. Some common questions involve the time commitment required, the amount of payment, if any, and the company conducting the research.

Inclusivity

The front lines of medical research need to be filled with individuals from diverse backgrounds to serve as a mirror of those we want to be enrolled in clinical trials. This means our research teams from the inside out need to be comprised of more minorities. Marketing materials should be representative to reach the widest percentage of the population, not merely the historical majority that have been enrolled in clinical trials.³

5. The Good News

A number of changes have been encouraged to increase the inclusion of diverse groups and racial and ethnic groups are not the only groups benefiting from the FDA’s vision for more diversity in clinical trials. Historically-excluded groups such as older populations, rare disease populations, and pregnant subjects, along with the recognition of sex, gender, identity, age, and disability have formed a part of efforts in previous Guidances from the FDA. However, LGBTQ plus individuals are also overdue for inclusion in trials.⁴ Overall, this speaks of a trend with great momentum to rectify previous long standing lack of diversity within clinical trials.⁵

6. Recommendations 

One place to start is with site staff. Site staff that “looks like” the participant and “speaks their first language” is more likely to bridge the trust gap. If sponsors want the population in clinical trials to be more diverse, some internal work needs to be done first or simultaneously, in order to lay down the foundation for successful recruitment.

The incorporation of translated advertisements into common submission materials is also a major step forward for sponsors. Those trial participants that do not speak English as a first language will have the same access to a clinical trial if the materials also reach them.

Lastly, by working with trusted community leaders like, for example, religious leaders, sponsors can build meaningful alliances.

It is important that stakeholders understand and have an awareness of historical biases that have led us where we are today with regard to minority inclusion. Sensitivity and respect toward these populations are imperative in building or repairing the trust bridge. Transparency, along with kindness, is a good place to start in order to repair and build on new relationships that form along the way in a clinical trial. With all these considerations in mind, researchers will be best equipped to take a deep dive into the rewards of what diversity and inclusion could finally look like.

Download the Whitepaper below:

References

1. H.R.6584 – 117th Congress (2021-2022): Diverse and Equitable Participation in Clinical Trials Act. (2022, February 3). https://www.congress.gov/bill/117th-congress/house-bill/6584/text
2. Shen MJ, Peterson EB, Costas-Muñiz R, Hernandez MH, Jewell ST, Matsoukas K, Bylund CL. The Effects of Race and Racial Concordance on Patient-Physician Communication: A Systematic Review of the Literature. J Racial Ethn Health Disparities. 2018 Feb;5(1):117-140., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5591056/?ref=guides.clarahealth.com
3. How Clinical Trial Researchers Can Build Trust in the Black Community, https://guides.clarahealth.com/building-trust-in-the-black-community-clinical-trials/
4. Rationale and approaches are well described in McNair, 2021. Making Clinical Research Inclusive: Strategies to Include the LGBTQIA+ Community in Research Trials, https://www.wcgclinical.com/insights/making-clinical-research-inclusive-strategies-to-include-the-lgbtqia-community-in-research-trials/
5. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry, https://www.fda.gov/media/127712/download; Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry, April 2018 https://www.fda.gov/media/112195/download; Rare Diseases: Common Issues in Drug Development Guidance for Industry January 2019 https://www.fda.gov/media/119757/download.

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