This whitepaper is brought to you by Quest Diagnostics.

How sponsors can meet the FDA’s diversity action plan requirements

The U.S. is imposing requirements to ensure clinical trial populations match each drug’s intended use. For pharma companies to comply with diversity action plan requirements, they must have access to data to define the population affected by the targeted disease. By knowing the details, sponsors can design diversity action plans and recruit and enroll the appropriate audience for their clinical trials.

Faced with the new requirements, forward-thinking sponsors are retooling their enrollment strategies to understand the age, gender, location, race and ethnicity of potential trial participants and ensure their clinical trial populations represent the intended use. This whitepaper explains:

• Why clinical trial enrollment requirements are changing
• The importance of aligning clinical trial and real-world populations
• FDORA, diversity action plans and what they mean for sponsors
• The need to define the demographic affected by the targeted disease
• How lab data helps find people who fit enrollment diversity criteria