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Design of Phase II Clinical Trials - UC Davis Health

1 Clinical and Translational Science Center1 Clinical and Translational Science CenterCLINICAL AND TRANSLATIONAL SCIENCE CENTERCLINICAL AND TRANSLATIONAL SCIENCE CENTERD esign of Phase II Clinical TrialsSusan Stewart, of BiostatisticsThe UC Davis CTSC receives support from the NIH National Center for Advancing Translational Sciences (award TR001860).2 Clinical and Translational Science Center2 Clinical and Translational Science CenterTopics Objectives TypesoMulti-stageoRandomizedoPlatformoCr ossover3 Clinical and Translational Science Center3 Clinical and Translational Science CenterPhase II Clinical Trials Phase II (NIH definition): Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate there a

Definition (Chow & Liu): Modified randomized block design in which each block receives more than one treatment at different dosing periods. Simplest case: each participant is randomized to receive 2 treatments, A and B, in the order AB or BA. Between the 2 treatments, there is a washout period. Design and Analysis of Clinical Trials (3rd Ed.)

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