Module 15 2022

19/05/2022

PMA/Class III - Clinical Requirements

Will EU clinical requirements be less than US requirements? Not necessarily…

Main drivers of study size are… • Claims • Whether animal/bench studies may be sufficient to answer some questions • Significance level, power, variability in the data (standard deviation), difference in treatment effect • Adequate data for sub group analysis • Sufficient representation of users/environments

• Sufficiently diverse patient population • Novelty relative to standard of care

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Diversity Plans

FDA DRAFT GUIDANCE – “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry”  Sponsors should define enrollment goals for underrepresented racial and ethnic participants as early as practicable in clinical development for a given indication.  RACE AND ETHNICITY DIVERSITY PLAN: Plan should begin with an assessment of any data that may indicate the potential for a medical product to have differential safety or effectiveness associated with race or ethnicity.  Sponsors should submit their Plan as part of the investigational plan included in the IDE application/discuss in a pre-submission.

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