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Session 7: Cancer Patient Journeys and Estimands
Session Chair(s)
Mouna Akacha, PhD
Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
Jonathan Haddad, MPH
HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States
Yan Wang, PhD
Statistical Team Leader, Division of Biometrics IV, Office of Biostatistics, OTS
FDA, United States
Cancer patients experience different disease journeys and clinical trials need to account for this diversity as it leads to multiple possible ways of defining the treatment effect, i.e. the estimand of interest. In this session we will first discuss some estimand opportunities and challenges specific to oncology drug development. Then we will focus on a drug development setting where the clinical benefit of a gene therapy to treat Lymphoma is to be investigated. A panel of various stakeholders will share their views on clinically meaningful estimands and targeted designs for this setting.
Learning Objective : At the conclusion of this session, participants should be able to:- Appreciate the estimand challenges and opportunities arising in oncology drug development
- Appreciate that different stakeholders may have different views on clinically meaningful estimand
- Be better informed to apply the estimand framework to their own clinical investigations
Speaker(s)
Cancer Patient Journeys and Estimands
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
Patient Journeys and Estimands: A case study of CAR-T in Lymphoma
Kapildeb Sen
Novartis Pharma, United States
Senior Director Biostatistics
Insights from a Cross-Pharma Working Group on Estimands in Oncology Trials
Satrajit Roychoudhury, PhD
Pfizer, Inc., United States
Executive Director, Statistical Research and Innovation
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
Kunthel By
FDA, United States
Biostatistician