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ISPY-2: Adaptive Design to Identify Treatments for Biomarker

Wathen, K (Johnson & Johnson)
Monday 15 August 2011, 14:45-15:25

Seminar Room 2, Newton Institute Gatehouse


The ISPY2 process is a new approach to conducting clinical research that utilizes a patientís 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 patientís 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.


[pdf ]


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