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Bayesian Adaptive Randomization for the I-SPY 2 SMART

Abstract Number:

3339 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Paper 

Participants:

Peter Norwood (1), Marie Davidian (2), Christina Yau (3), Anastasios Tsiatis (4), Denise Wolf (3)

Institutions:

(1) Quantum Leap Healthcare Collaborative, N/A, (2) North Carolina State University, N/A, (3) UCSF, N/A, (4) North Carolina State Univ, N/A

Co-Author(s):

Marie Davidian  
North Carolina State University
Christina Yau  
UCSF
Anastasios Tsiatis  
North Carolina State Univ
Denise Wolf  
UCSF

First Author:

Peter Norwood  
Quantum Leap Healthcare Collaborative

Presenting Author:

Peter Norwood  
N/A

Abstract Text:

The I-SPY 2 sequential multiple assignment randomized trial (SMART) is designed to identify optimal treatment regimes for breast cancer. This design has three stages meant to mimic the decision-making process for sequential treatment. Subjects begin the trial with a first stage randomization to available arms. If interim information on the tumor looks promising, they can go to surgery after the first stage and their pathological complete response (pCR) status is assessed. Otherwise, they proceed to a second stage of randomization. If they do not go to surgery at the second stage, they receive a third stage of treatment then go to surgery. Due to many possible treatment regimes and the desire to improve outcomes in the trial, response-adaptive randomization provides potential statistical and ethical benefits over uniform randomization. We present a Bayesian adaptive randomization scheme known as Thompson sampling that randomizes subjects to arms based on the posterior probability that they maximize the chance of a pCR. Simulation studies show our method improves in-trial pCR rates and identifies optimal regimes at similar rates as uniform randomization.

Keywords:

SMART|adaptive randomization|clinical trials|precision medicine|sequential decision making|multi-armed bandits

Sponsors:

Biometrics Section

Tracks:

Personalized/Precision Medicine

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