FDA Diversity in Clinical Trials: A 5-Step Plan Template

It’s official. The U.S. Food & Drug Administration (FDA) has released its updated guidance on creating Diversity Action Plans for clinical trials. Through the FDA diversity in clinical trials recommendations, the regulatory agency aims to build upon already established standards to support a more robust health equity focus throughout bioscience research. 

However, developing a sufficient Diversity Action Plan is easier said than done. The FDA now expects more information on how trials will include participants from a multitude of historically marginalized demographics. And clinical research sponsors will need to be prepared to meet these standards. 

Here are five must-have components of your Diversity Action Plan that will help you adhere to the FDA’s updated recommendations. 

1. Start with the foundation of your Diversity Action Plan  

The latest FDA diversity in clinical trials guidance urges clinical trial sponsors to outline comprehensively their target demographics, metrics, and how they plan on meeting diversity goals. Thus, an ideal starting point is to introduce how your Diversity Action Plan aligns with the FDA’s priorities. 

Briefly explain the purpose of your Diversity Action Plan, your specific goals, and the disease-specific rationale for enhancing diversity in clinical trials. Remember — your document must not exceed 10 pages, to highlight clearly how your Diversity Action Plan plans on reaching its enrollment goals.   

Use this opportunity to define the scope of the Diversity Action Plan, including the specific clinical trial(s) it applies to, phases of the trial, and target populations. Dive into how it will support different steps of research — from before Phase III all the way to after your drug goes to market. Describe how data will be collected in a respectful and consistent manner, ensuring participants' privacy and confidentiality.   

Acclinate’s blend of community engagement and advanced, AI-driven analytics embeds health equity strategies into multiple steps of clinical research — providing sponsors with a head start on evolving FDA recommendations. 

2. Clearly identify your target demographics 

A clear distinguishing factor between previous FDA diversity in clinical trials recommendations and the latest guidance is a greater emphasis on intersectionality. It urges considerations for age, sex, gender identity, socioeconomic status, geographic location, and other identifiers that may overlap and affect medication efficacy.  

That’s why any Diversity Action Plan should provide data on the current demographic makeup of the disease or condition being studied — including race, ethnicity, sex, gender identity, age, and other relevant factors. Include prevalence and incidence rates across different demographic groups. Use epidemiological information to illustrate the need for diversity, such as historical enrollment patterns in clinical trials for this condition and existing disparities in representation. Highlight gaps in the status quo understanding of how the disease or condition affects specific populations. 

Set clear, measurable goals for including underrepresented populations in the trial. Get specific with percentages and target numbers for each demographic category, as well as eligibility criteria based on unbiased research. For example, if a certain condition affects 20% of Black and 10% of Hispanic communities in the U.S., your enrollment goals should reflect these percentages. Describe your rationale, including the public health and scientific implications of achieving more representative participant pools.  

3. Explain your strategies for recruitment and retention 

Now that you’ve set the stage for your Diversity Action Plan and clearly outlined your demographic targets, you’ll need to dive into how you’ll recruit and retain participants.  

Develop a comprehensive community engagement strategy that involves building relationships with local organizations, patient advocacy groups, faith-based organizations, and other community stakeholders. Include campaigns for addressing historical mistrust of medical research in certain communities, such as hosting informational sessions and partnering with trusted community leaders. Detail plans for conducting culturally tailored outreach and education initiatives that will resonate with target populations. 

Describe specific recruitment channels — like targeted social media campaigns — and discuss how you'll use digital tools to facilitate recruitment and pre-screening in a culturally competent manner. Provide examples of inclusive messaging and visuals that will be used in recruitment materials to engage potential participants. 

Outline logistical and emotional support services that will be provided to participants to enhance retention. These can include transportation assistance, flexible scheduling options, and other participant support strategies. Explain the importance of ongoing, culturally appropriate communication with participants, including regular check-ins and updates on the trial's progress. Don’t forget to include plans for addressing potential obstacles to retention, such as economic hardship, language barriers, or lack of trust in the research process. 

Acclinate leverages its NOWINCLUDED community platform to access, engage, and mobilize participants from communities of color with disease-specific awareness and education campaigns and events. Learn how NOWINCLUDED was used to increase African American participation in an Alzheimer’s trial. 

4. Outline how you’ll select sites and investigators 

When it comes to advancing diversity in clinical trials, it’s about people and space. The FDA understands this fact fully, and strongly recommends selecting and justifying clinical trial sites with a health equity lens. 

Define criteria for selecting trial sites that have a track record of enrolling diverse populations or are accessible to historically marginalized communities. Ensure trial site selection accounts for urban, suburban, and rural areas to capture a wide range of locations. Include plans for conducting site assessments to verify that facilities are accessible and welcoming to all participants, including those with disabilities.  

Who you choose as investigators also plays a significant role. Though one study points to an acknowledgement of the importance of equity among principal investigators at large, implicit bias can subvert effective DEI efforts in clinical research. Hence, sponsors will need to address head-on their plans for ensuring a diverse investigator selection and training research staff in cultural competence. 

Acclinate empowers clinical trial sponsors to better understand participation potential with its AI-powered predictive analytics tool, e-DICT. 

5. Include a roadmap for monitoring, training, & improvement 

Improving diversity in clinical trials isn’t just about the initial process of engaging and including underrepresented communities. It’s also essential to monitor progress throughout research phases, continuously train investigators and other staff to foster inclusion, and assess areas of improvement. 

In your Diversity Action Plan, establish a timeline for regularly reviewing enrollment and retention data, with a focus on meeting determined goals. Include strategies for using data analytics to identify trends or challenges in achieving objectives (e.g., under-enrollment of specific population groups). Define procedures for adjusting recruitment and retention strategies based on these findings, such as reallocating resources or enhancing community outreach efforts. Establish a clear process for collecting feedback from participants, as well as how you will report progress on diversity goals to the FDA and other stakeholders.   

Develop training protocols for investigators and staff that cover cultural competency, unconscious bias, and effective communication with diverse populations. Provide resources for investigators to help them understand social determinants of health that may affect participants' access to and experience in the trial. Include ongoing education opportunities, such as webinars or workshops, that will keep staff informed about best practices for engaging diverse populations.  

A two-pronged approach to diversity in clinical trials 

Developing an effective Diversity Action Plan is essential for meeting the FDA’s latest guidelines. But one of the best ways to ensure your trial meets evolving recommendations is by integrating a health equity focus early in the process.  

Acclinate enables sponsors to effectively and efficiently accomplish this through a two-pronged approach: NOWINCLUDED, a first-of-its-kind community platform, paired with e-DICT, a cutting-edge, AI-powered analytics solution. Ready to see how Acclinate can improve DEI for your clinical trial? Schedule a 1:1 meeting with our team.