Differences between clinical trial and real-world demographics raise questions about whether regulators can extrapolate safety and efficacy data to show the benefits of a drug outweigh the risks in the intended use population. Studies have demonstrated that trial data cannot always be generalized across different groups.
As a result, the FDA has created requirements to ensure clinical trial populations match each drug’s intended use, known as a diversity action plan. To comply with these new requirements, drug development sponsors need reliable data to define the targeted population for their therapy. With these details, sponsors can design diversity action plans and recruit and enroll the appropriate audience for their clinical trial.
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.
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