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ISPY-2: Adaptive Design to Identify Treatments for Biomarker

Presented by: 
K Wathen [Johnson & Johnson]
Monday 15th August 2011 - 14:45 to 15:25
INI Seminar Room 2
Session Title: 
Treatment individualization
Session Chair: 
Peter Mueller
The ISPY2 process is a new approach to conducting clinical research that utilizes a patient’s biomarkers measurements to predict which treatment is most likely to provide benefit. Patients will be adaptively randomized and the treatment assignment probabilities will be altered to favor the treatment that, on average, appears superior for a given patient’s biomarker characteristics. In contrast to the traditional phase II clinical trial, which has a fixed number of treatments, the ISPY2 process will allow new agents to enter the trial as they become available and will "graduate" treatments based on the likelihood of future success in a subset of the patient population. A simulation study is presented and examples given to demonstrate the adaptive nature of the design.
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Presentation Material: 
University of Cambridge Research Councils UK
    Clay Mathematics Institute London Mathematical Society NM Rothschild and Sons