Preparing For FDA Diversity Plans: A Checklist For Sponsors
Racially and ethnically diverse populations are frequently underrepresented in clinical research, despite being disproportionately affected by certain diseases and health conditions. The FDA is expected to issue new requirements for sponsors to submit Race and Ethnicity Diversity Plans to address these disparities, which could go into effect before the end of the year. These plans will require many sponsors to revisit their approach to patient recruitment, so now is the time to start preparing. Here are nine steps we recommend taking now.
1. For the Disease of Interest, Understand the Prevalence in Underrepresented Populations
Begin by analyzing the prevalence of the disease or condition your trial aims to treat within underrepresented racial and ethnic populations. This will help in setting realistic enrollment goals for these populations. This information may come from multiple data sources including previous clinical trials, public health data, or epidemiological sources. Spatial epidemiology data, or data on the prevalence of diseases within specific demographics and geographic areas, can be especially helpful here. Having spatial representation of prevalence data may aid in placement of study sites or community engagement activities.
2. Set Enrollment Goals And Identify Barriers
Based on the data, set enrollment goals for underrepresented racial and ethnic clinical trial participants. This should also include considerations for pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenomic data that may impact how trial participants respond to drugs. In some cases over enrollment of certain groups may be needed to have the power to detect the potential PK, PD, or pharmacogenomic differences.Understand and plan for the barriers that may prevent underrepresented populations from participating in trials, such as language barriers, lack of access to healthcare resources (including a potential lack of reliable internet access), unfamiliarity with the process, and potential skepticism.
3. Create a Comprehensive Plan to Reach Enrollment Goals
Enrolling diverse populations may come with a unique set of challenges. There may be socioeconomic factors, language barriers, or historical hesitancy to overcome. Some considerations may be to engage with community partners who are trusted leaders at a local level, put new study sites in underrepresented neighborhoods, and recruit new investigators with whom underrepresented populations may identify.
4. Create a Comprehensive Study Design
Your study design should be inclusive and consider the potential impact of race, ethnicity, and other variables, such as gender, geographic location and socioeconomic factors, on the safety and effectiveness of the drug or device. This includes considering factors like skin pigmentation that may affect device performance. This may also include considering the impact of other racial or cultural factors that can impact the outcome of your study. Some of these may be diet, exercise, cultural healing practices, or health literacy.
5. Document the Plan
Document these details along with the scope of the trial, including the study design, study population, endpoints, and geographic locations. Also for longer term trials regular assessment and documentation of goal to actuals should be made. This will allow for modification of recruitment strategies if needed.Plan to collect data that could explore potential differences in drug or device effectiveness associated with race or ethnicity throughout the product’s lifecycle.
6. Prepare for Submission
Prepare to submit your Race and Ethnicity Diversity Plan at the appropriate time. For drug trials, this should be during drug development, and for medical device trials, it should be along with the investigational device exemption (IDE) application.
7. Understand the Consequences of Non-Compliance
Be aware that failing to meet diversity requirements could delay approval or even lead to rejection of a drug or device.
8. Make Your Diversity Plan Part of the Entire Life Cycle of Your Drug or Device
Maintain regular communication with patients to answer questions, build trust, and promote retention throughout the trial lifecycle.
9. Find The Right Clinical Trial Recruitment Partner
Before working with a patient recruitment firm, ask for more details about how they will help you meet your goals for diverse patient recruitment.Do they have access to extensive patient databases or patient registries? Are they simply using social media targeting parameters, or are they reaching out in more personal, proactive ways as well? Do they have partnerships with community-based physicians and organizations who can refer patients?
About M&B Sciences
M&B Sciences combines deep expertise in clinical trials, spatial epidemiology, and technology with authentic community partnerships. We use hyperlocal health and demographic data to identify ideal patient populations with a focus on diversity. Our Neighborhood Trials app makes it easy for patients to find trials close and easy for them to enroll, while our platform makes it easy for sponsors to screen them. If you’re ready to learn more about what we can offer, contact us for a consultation.We also have a broad network of community partners who have established trust with diverse patient populations. This helps sponsors overcome challenges sponsors encounter, such as a lack of awareness of clinical trials or language barriers.