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Thursday, July 1 • 2:00pm - 3:00pm
#442 SL: Population Diversity Considerations in Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-664-L04-P; CME 1.00; IACET 1.00; RN 1.00

To promote health equity and reduce disparities in racial and ethnic minorities, this session will discuss potential trial designs and statistical methods to increase the participation of minorities and/or diversity of populations in clinical trials.

Learning Objectives

Discuss considerations and strategies in clinical trials' planning and conduct to enhance population diversity; Describe statistical challenges in clinical trial subgroup disparities; Identify potential trial designs and methodologies to mitigate disparity factors in the patient population.


Freda Cooner, PhD


Considerations on the Use of Analytics and Technology to Enhance Diversity in Clinical Trials
Demissie Alemayehu, PhD

Disparities by Demographic Subgroups in Clinical Trials Submitted to the FDA
Laura Fernandes, PhD

Ruthie Davi, PhD, MS

avatar for Freda Cooner

Freda Cooner

Executive Director, Biostatistics, Arcutis Biotherapeutics, Inc., United States
Dr. Freda Cooner is currently a Director, statistical innovation in Amgen. She is leading the exploration of innovative design options for several oncology and non-oncology products, including master protocols and seamless trials. Before joining Amgen late last year, she was an associate... Read More →
avatar for Ruthie Davi

Ruthie Davi

Vice President, Data Science and Statistician, Medidata, a Dassault Systèmes company, United States
Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systèmes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the... Read More →

Demissie Alemayehu

Vice President, Biostatistics, Pfizer Inc, United States
Demissie Alemayehu is Vice President of Statistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry and academic institutions. He has been influential externally, with decades of research and teaching experience at major institutions. He has... Read More →
avatar for Laura Fernandes

Laura Fernandes

Statistician, OB, DBIX, OTS, CDER, FDA, United States
Dr. Laura Fernandes is a statistical reviewer in the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER), U.S. FDA. She received her PhD in biostatistics from the University of Michigan, Ann Arbor. Prior to joining the FDA, she worked as a research analyst... Read More →

Thursday July 1, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session
  • Beginner Intermediate
  • Featured Topics Special Populations
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Special Populations,Diversity Equity and Inclusion,Innovative Trial Design
  • Tags Session