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A Pediatric Research Imperative: The Why and How of Addressing Diversity in Pediatric Research

ASCPT Members-Only Webinar Presented by the Regulatory Science (RS) & Special Populations (SPO) Communities

Speakers: Tamorah Lewis, MD, PhD; Anuradha Ramamoorthy, PhD.
Moderators: Elimika Pfuma Fletcher, PharmD, PhD; Jinshan Shen, PhD

Diversity in clinical trials is increasingly being discussed. FDA has published guidance documents including those addressing diversity plans and enhancing diversity in clinical trials. Although efforts are being proposed to enhance diversity in adult clinical trials, we have less discussion related to pediatric clinical research. This webinar will focus on need for and opportunities for diversity considerations in pediatric trials. This has been highlighted by efforts related to pharmacogenomics in pediatrics and the recent focus on translating drug-drug interactions and impact of renal and hepatic impairment from adults to pediatrics. Racial and ethnic diversity will be the main focus, but other aspects of diversity related to clinical pharmacology will be addressed in this webinar. This session will focus on opportunities, considerations and challenges related to diversity in pediatric trials. We will include the Neonatologist and Clinical Pharmacologist who will share specific aspects that can be considered by researchers, regulators and industry to address diversity in clinical research and specifically as it relates to pediatrics. Topics will include: (1) Regulatory experience and expectations as related to diversity in clinical trials. (2) Impact of structural racism and disadvantage for minoritized families on clinical care and research (3) Some solutions to increasing diversity in clinical trial including pediatric trials.

Learning Objectives: 1. Discuss the current status, causes of and importance of addressing diversity in clinical trials 2. Discuss specific considerations for diversity in pediatric clinical trials. 3. Discuss solutions to addressing diversity in pediatric clinical trials.

Dec 5, 2022 12:00 PM in Eastern Time (US and Canada)