Full course description
Policies from the NIH and FDA on the inclusion and reporting practices related to gender, sex, race, and ethnicity in clinical trials as well as the rationale behind these policies will be discussed. Other topics in this course include subgroup reporting, the role of sex and gender in clinical trials and data implications associated with this topic, and the effects of racial misreporting and participation in clinical trials on data and healthcare outcomes.
At the end of this course, the learner will be able to:
1. Identify NIH and FDA policies on inclusion and reporting practices by sex, race, and ethnicity.
2. Explain the importance of diverse, underrepresented groups in clinical trials.
3. Understand the statistical implications of the inclusion or lack of inclusion of sub-groups in clinical trials
1. NIH and FDA policies on inclusion and reporting by sex, race, and ethnicity
2. Subgroup reporting and statistical analyses
3. Heterogeneity of intervention effects by sex and race
4. Implications of inclusion practices in clinical trial design