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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Session 6: Diversity and Inclusion

Session Chair(s)

Rima Izem, PhD

Rima Izem, PhD

  • Associate Director Statistical Methodology
  • Novartis, Switzerland
Mark Rothmann, PhD

Mark Rothmann, PhD

  • Director, Division of Biometrics II, Office of Biostatistics, OTS, CDER
  • FDA, United States
Recent FDA documents and action plans have provided guidance to industry on improving the diversity in clinical trials and enhancing the collection and availability of demographic subgroup data. Diversity in clinical trials can be improved by broadening eligibility criteria, avoiding unnecessary exclusions, and improving trial recruitment outreach. Having a more diverse clinical trial population will facilitate evaluation of treatment effect in different subgroups and will answer generalizability questions to the indicated population. This session will discuss the state of the art in improving diversity in clinical trials and the implications on statistical approaches and communication of results.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Explain new regulatory guidance documents on increasing diversity in clinical trials
  • Discuss statistical methods for estimating treatment effects in the presence of heterogeneous treatment effects
  • Discuss (statistical) communication about clinical trials results to reach a broad lay audience

    Speaker(s)

    Richardae Araojo, PharmD, MS

    Patient Diversity in Clinical Research

    Richardae Araojo, PharmD, MS

    • Associate Commissioner for Minority Health, Director, Office of Minority Health
    • FDA, United States
    Thomas Louis, PhD

    Subgroups and Bayes

    Thomas Louis, PhD

    • Professor Emeritus, Department of Biostatistics
    • John Hopkins Bloomberg SPH, United States
    Steven Snapinn, PhD

    Goals of Subgroup Analyses, Assessing Standards for Analysis of Differences, and Limits of Interpretation

    Steven Snapinn, PhD

    • Independent Consultant
    • Seattle-Quilcene Biostatistics LLC, United States
    Mark Rothmann, PhD

    Panelist

    Mark Rothmann, PhD

    • Director, Division of Biometrics II, Office of Biostatistics, OTS, CDER
    • FDA, United States
    Barbara E Bierer, MD

    Panelist

    Barbara E Bierer, MD

    • Faculty Director, MRCT Center; Professor of Medicine
    • Harvard Medical School, United States

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    Preconference Short Courses

    Short Course 1: Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making

    Short Course 2: Statistical Analyses Targeting Estimands