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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)
Speaker
Ralph D'Agostino, PhD
Wake Forest School of Medicine, United States
Professor
Statistics, Rabbits and Hats
Andrew Stone, MSc
AstraZeneca, United Kingdom
Head of Statistical Innovation
Single Arm Trials in Hematology and Oncology Drug Applications: FDA Review Examples
Yuan-Li Shen, DrPH
FDA, United States
Division Director, Division of Biometrics IX, OB, OTS, CDER
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