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Session 6: Diversity and Inclusion
Session Chair(s)
Rima Izem, PHD
Associate Director Statistical Methodology, Novartis, Switzerland
Mark Rothmann, PHD
Division Director, OTS, OB, 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
Associate Commissioner for Minority Health, Director, Office of Minority Health , FDA, United States
Patient Diversity in Clinical Research
Thomas Louis, PHD
Professor Emeritus, Department of Biostatistics, John Hopkins Bloomberg SPH, United States
Subgroups and Bayes
Steven Snapinn, PHD
Independent Consultant, Seattle-Quilcene Biostatistics LLC, United States
Goals of Subgroup Analyses, Assessing Standards for Analysis of Differences, and Limits of Interpretation
Mark Rothmann, PHD
Division Director, OTS, OB, CDER, FDA, United States
Panelist
Barbara E Bierer, MD
Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School, United States
Panelist
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