Diversity on demand: How to meet new FDA guidance for clinical trials

The FDA recently released draft guidance that provides details on creating Diversity Action Plans (DAPs) for clinical trials. This is part of a continuing effort to address ongoing challenges in broadening diversity and ensuring that clinical trials represent the populations that will benefit most from new therapies.

There are essentially three sections that need to be included in a DAP:

• Enrollment goals - Sponsors need to set enrollment goals for race, ethnicity, sex and age group based on the population the product is intended to treat. 
  
  
• Rationale for enrollment goals - This should include background on the condition, natural history, risk factors, and disease prevalence with a breakdown by race, ethnicity, sex and age group. It should also include any data that suggests certain demographic groups, such as females, children or particular ethnic groups, will be affected differently by the product.
  
  
• Measures to meet enrollment goals - This section provides a description of enrollment and retention strategies and a plan for monitoring enrollment to ensure goals are on track and ultimately met.  

The following explains how the HealthVerity Provider Diversity and Diagnosis Index (PDI) Masterset offers a single solution to help pharma companies meet this soon-to-be-required guidance. 

Enrollment goals made easy

PDI is a nationally syndicated report that leverages medical, pharmacy and consumer data to calculate the racial diversity, demographic mix and diagnosis of patients for over 2 million healthcare providers, all in a HIPAA-compliant manner. The report includes the following:

• Race
• Gender
• Age
• Income range
• Payer type (Medicare, Medicaid or commercial)
• ICD-10 code

The report can be generated for a particular diagnosis, providing all of the demographic insights you need to set appropriate enrollment goals for a DAP.

Data-driven rationale

If registries or published studies are not available for the condition a product is intended to treat, it can be challenging to determine the disease prevalence for specific demographic groups. Even with real-world data (RWD) sources, such as medical claims and electronic medical records, this information is often not provided due to privacy regulations. Additionally, to gain an in-depth understanding of the patient population, you would need to secure multiple data sources from across the U.S., in an interoperable and normalized fashion, and ensure it remains HIPAA compliant. 

With PDI, you have 10 RWD sources that are already interoperable, HIPAA compliant and represent over 110 million people. PDI provides all of the demographic data you need to justify your enrollment goals in a single report. 

Recruitment that gets results

PDI can assist with clinical trial recruitment in a number of ways:

1. Identify physician partners - With PDI, you can discover physicians treating patients with the condition of interest and an appropriate demographic mix to serve as trial investigators or help with recruitment efforts.
   
   In addition to providing patient demographics, PDI provides race and ethnicity insights for physicians. This is important because research has shown that patients prefer to receive care from someone of a similar ethnic background.¹ Additionally, non-white providers are more likely to work in underserved geographies, making these physicians best positioned to inform, educate and attract the optimal mix of clinical trial subjects.²  
   
   
2. Target outreach - With insights from PDI you can create models of the ideal clinical trial population and better target advertising, education and recruitment efforts based on patient attributes and provider zip codes.
   
   
3. Locate ideal trial sites - The insights from PDI, including the provider zip code, also help to identify ideal trial sites based on disease prevalence and the demographic characteristics of the community. Hosting trial sites near patients of interest limits transportation issues, which can aid in retention.

Increasing diversity in clinical trials is not only becoming more and more of an imperative for the FDA, but it is vital to ensuring that medications are being developed to effectively treat the patients most impacted by the condition. By leveraging our privacy-protecting technology and vast healthcare data ecosystem, HealthVerity PDI can ease the burden on pharma manufacturers and CROs in ensuring this equity and ultimately improving the health and wellbeing of our nation.   

For more information about PDI or a complementary data sample:

 ¹ LaVeist, T., Nuru-Jeter, A. & Jones, K. The Association of Doctor-Patient Race Concordance with Health Services Utilization. J Public Health Pol 24, 312–323 (2003). https://doi.org/10.2307/3343378.

² Kara Odom Walker, Gerardo Moreno, Kevin Grumbach, The Association Among Specialty, Race, Ethnicity, and Practice Location Among California Physicians in Diverse Specialties, Journal of the National Medical Association, Volume 104, Issues 1–2, 2012, Pages 46-52, ISSN 0027-9684, https://doi.org/10.1016/S0027-9684(15)30126-7.