DIA 2018 Global Annual Meeting

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-651-L04-P; CME 1.25; IACET 1.25; RN 1.25

There has been considerable progress in how sex differences are incorporated into both clinical trial development and how FDA reviews this data. The FDA has published several regulations and guidance in regard to women and sex and gender inclusion and incorporation into the review process. This forum will walk through the impact of these requirements and recommendations on the inclusion of women in clinical trials and comprehensive review of sex differences in clinical trials. It will dive further into the drug approval timeline focusing on the role of pharmacological and toxicology reviewers at the FDA. Participants will have the ability to test their knowledge on the drug approval process as well as walk through case study examples of drugs approved or rejected from the market. Presenters will begin with a brief overview of the regulatory history of the inclusion of women in research activities and clinical trials. In addition, presenters will discuss the evaluation of potential sex differences throughout the process of drug development including the pre-clinical and clinical phases.

Learning Objectives

Analyze the impact of regulatory requirements and policy on the inclusion of women in clinical trials; State the requirements for the use of male and female animals in preclinical toxicity studies; Recognize when and how sex is considered in the FDA drug review and approval process; Identify at least one method which FDA utilizes to communicate findings regarding sex differences to the public.

Chair

Erin South, PharmD, RPh

Speaker

Gender Inclusion and Analysis of Sex Differences in Clinical Trials Supporting Drug Approvals
Erin South, PharmD, RPh

Sex Considerations in Drug Development: A Nonclinical Perspective
John H. Dubinion, PhD

Clinical Evaluation of a New Drug: Looking for Sex Differences
Milena M Lolic, MD, MS