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Session 2: Single-arm Trials and Use of Historical Data
Session Chair(s)
Pandurang M Kulkarni, PHD
Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics, Eli Lilly and Company, United States
Rajeshwari Sridhara, PHD
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Single arm trials are on their way back in Oncology and continue to be present in rare diseases. In this session, we will discuss the reasons for this shift, the circumstances in which single arm trails are useful, and how to utilize the historical control data in such trials – in an appropriate practical and statistical sense. The pitfalls of using single arm trials and historical controls especially around Exchangeability (with or without controlling for covariates and time) and obtaining adequate data to assess inter-study variability (with or without controlling for covariates and time) and possible solutions to address these pitfalls will be examined.
Speaker(s)
Ralph D'Agostino, PHD
Professor, Wake Forest School of Medicine, United States
Speaker
Andrew Stone, MSC
Head of Statistical Innovation, AstraZeneca, United Kingdom
Statistics, Rabbits and Hats
Yuan-Li Shen, DrPH
Division Director, Division of Biometrics IX, OB, OTS, CDER, FDA, United States
Single Arm Trials in Hematology and Oncology Drug Applications: FDA Review Examples
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