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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)
John Scott, PhD, MA
Division Director, Office of Biostatistics, CBER, FDA, United States
Cancer Patient Journeys and Estimands
Kapildeb Sen
Senior Director Biostatistics , Novartis Pharma, United States
Patient Journeys and Estimands: A case study of CAR-T in Lymphoma
Satrajit Roychoudhury, PhD
Executive Director, Statistical Research and Innovation, Pfizer, United States
Insights from a Cross-Pharma Working Group on Estimands in Oncology Trials
Robert J. Temple, MD
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER, FDA, United States
Kunthel By
Biostatistician, FDA, United States
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