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DIA 2021 Global Annual Meeting

The FDA's Clinical Trial Diversity Initiative in the Setting of the Ongoing COVID-19 Pandemic

Session Chair(s)

Wambui Chege, MD, FACP

Wambui Chege, MD, FACP

  • Physician Policy Advisor, DMPD, OMP, CDER
  • FDA, United States
FDA’s commitment to Clinical Trial (CT) diversity is integral to the agency’s mission. Recognizing that COVID-19 affects certain populations differently, FDA’s session will explore solutions and stakeholder collaborations in support of CT diversity.
Learning Objective : Describe the need to include under-represented patient populations in US clinical trials; Discuss a range of efforts to incorporate diversity into clinical trials, as well as FDA recommendations of inclusive trial practices and trial methodologies to facilitate the enrollment of broader populations.

Speaker(s)

Richardae Araojo, PharmD, MS

Panelist

Richardae Araojo, PharmD, MS

  • Associate Commissioner for Minority Health, Director, Office of Minority Health
  • FDA, United States
John Concato, MD, MPH, MS

Panelist

John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States
Peter Basseches, PhD

Panelist

Peter Basseches, PhD

  • Distinguished Scientist, Global Regulatory Affairs and Clinical Safety
  • Merck & Co., Inc, United States
Anu Osinusi, MD, MPH

Panelist

Anu Osinusi, MD, MPH

  • Vice President, Hepatitis, Respiratory and Emerging Viruses
  • Gilead Sciences, Inc., United States
Richard Knight, MBA

Panelist

Richard Knight, MBA

  • President
  • American Association of Kidney Patients , United States
John Whyte, DrMed, MD, MPH

Panelist

John Whyte, DrMed, MD, MPH

  • Chief Medical Officer
  • WebMD, United States