The Georgia Clinical & Translational Science Alliance - Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

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.

Learner Objectives:

• At the end of this course, the learner will be able to:
• Identify NIH and FDA policies on inclusion and reporting practices by sex, race, and ethnicity.
• Explain the importance of diverse, underrepresented groups in clinical trials.
• Understand the statistical implications of the inclusion or lack of inclusion of sub-groups in clinical trials

Course Topics:

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

Speaker:

Wendy Mack, PhD, is the Director of the Biostatistics, Epidemiology, and Research (BERD) Core at the Southern California Clinical and Translational Science Institute (SC-CTSI) and a Professor in the Department of Preventative Medicine, Division of Biostatistics in the Keck School of Medicine at USC. She received her doctorate in Biometry from USC. She has over 25 years of experience in directing biostatistical and data coordination activities for multiple single-centered and multi-centered clinical trials and observational studies. She has directed the biostatistical and data coordination activities of randomized clinical trials (the majority being NIH- or PCORI-funded), as well as NIH-funded program projects, and has a wealth of experience and expertise in analysis of longitudinal clinical trial outcomes.With over 30 years of teaching USC students, Wendy remains deeply committed to training the next generation of clinical investigators and biostatisticians. As the former director of the MS programs in Biostatistics and Epidemiology in the Department of Preventive Medicine, she has mentored numerous K-awardees, junior faculty, and graduate students (MS and PhD). wmack@usc.edu

Learner Level: Intermediate

Audience: This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Pass the quiz with 100% of questions answered correctly
• Complete the evaluation at the end
• Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
• Start Date: 09/30/2022
• Expiration Date: 09/29/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.