Diversity planning in early development: Making your Phase I studies do more

The FDA’s 2024 update to their diversity guidance will require sponsors to submit their Diversity Action Plan (DAP) no later than with their phase III protocol submission. Additionally, the updated guidance also goes beyond race and ethnicity to include other demographic characteristics such as age and sex, while also considering socioeconomic factors. 

The FDA encourages the early collection of pharmacokinetic, pharmacodynamic, and pharmacogenomic data from diverse populations to inform analyses of drug exposure and response, which should be included in the scope of the product development section of the diversity plan.

In this webinar, clinical development experts will discuss the benefits of implementing a diversity strategy in Phase I, the need for it in indications like asthma where black and Hispanic people have higher rates of incidence and exacerbations relative to other races, and operational and recruitment considerations for efficient enrolling diverse populations in phase I. 

Webinar attendees will learn:

• What the latest FDA Draft diversity guidance means for clinical research 
• The impact of underrepresentation in clinical trial on health outcomes and generalizable results
• How implementing a diversity plan in phase I creates efficiencies in later phase clinical development. 
• How to use the ethnobridging model to fulfill diversity plan data requirements
• Strategies to incorporate diversity planning in global early phase trials.
• Opportunities to enhance inclusive respiratory clinical research in indications like asthma, where black people have the highest rate of incidence for current asthma.