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DIA/FDA Biostatistics Industry and Regulator Forum
Session 6: Diversity and Inclusion
Session Chair(s)
Rima Izem, PhD
- Associate Director Statistical Methodology
- Novartis, Switzerland
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)
Patient Diversity in Clinical Research
Richardae Araojo, PharmD, MS
- Associate Commissioner for Minority Health, Director, Office of Minority Health
- FDA, United States

Subgroups and Bayes
Thomas Louis, PhD
- Professor Emeritus, Department of Biostatistics
- John Hopkins Bloomberg SPH, United States
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
Panelist
Mark Rothmann, PhD
- Director, Division of Biometrics II, Office of Biostatistics, OTS, CDER
- FDA, United States
Panelist
Barbara E Bierer, MD
- Faculty Director, MRCT Center; Professor of Medicine
- Harvard Medical School, United States
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making
Short Course 2: Statistical Analyses Targeting Estimands