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Clinical Trial Designs
Symposia

Symposium 6: Increasing Diversity in Clinical Trials: What Will it Take for Us to Close the Gap?

Monday, September 9, 2024
8:00 AM – 9:30 AM ET
Location:Grand Ballroom D
CE: 1.5

Target Audience:

The target audience for this Symposium is professional research scientists, staff and physicians involved in clinical drug development, as well as research, pharmacists, graduate students and post-doctoral fellows/trainees. The Symposium is interdisciplinary for all healthcare professions and across work settings for academia, industry, regulatory agencies and clinical settings.



Description:

It is essential for clinical trials, considered the "gold standard" for generating clinical evidence before drug approval, to include diverse and clinically-relevant populations so that broad communities benefit from the scientific advancement. As such, the enhancement of clinical trial diversity is a high priority for stakeholders from academia, government agencies, the pharmaceutical industry and patients. Among the various stakeholders, the research teams conducting clinical trials can play a major role in supporting this mission by designing modern patient-centric trials, mobilizing resources to support the inclusion of diverse patient populations and thoughtful interpretation of clinical trial results to impact the medicine's use. This Symposium focuses on sharing examples from clinical study programs and recent learnings from initiatives to demonstrate the potential solutions and directions that clinical teams can drive to improve trial diversity. In addition, it will provide examples of how clinical pharmacology and those involved in clinical studies help to advance this goal. Innovative study designs (e.g., supported by real-world data) that improve trial diversity and thoughtful data analysis approaches that impact medicine use will be highlighted.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Restate the missions and key strategies of clinical study programs toward achieving the clinical trial diversity goals;
  • Describe what clinical study team members, including clinical pharmacologists, can do to advance the goal at various stages of drug development and envision application in their study programs;
  • Express a global mindset and perspective.

Presentations:

  • Clinical Trial Diversity: What Comes to Your Mind?

    Co-Chair & Faculty: Shuangwu (Cheryl) Li, PhD – Takeda Pharmaceutical Co Ltd

  • Clinical Pharmacology Considerations for Diversity During Drug Development & Regulatory Assessment

    Co-Chair & Faculty: Anuradha Ramamoorthy, PhD – US Food & Drug Administration

  • Clinical Pharmacology Strategies to Advance Clinical Trial Diversity: Industry Perspectives

    Faculty: Gianluca Nucci, PhD (he/him/his) – Pfizer Inc

  • Case Examples on Enhancing Clinical Trial Diversity from Academic & Clinical Development Perspectives

    Faculty: R. Donald Harvey, PharmD (he/him/his) – Emory Univ School of Medicine

  • Discussion, Questions & Answers, Learner Feedback & Evaluations