Phase II clinical trial are generally single arm trial where a homogeneity assumption is placed on the response. In practice, this assumption may be violated resulting in a heterogeneous response. This heterogeneous or overdispersed response can be...
The phase II clinical trial is a critical step in the drug development process. In the oncology setting, phase II studies typically evaluate one primary endpoint, which is efficacy. In practice, a binary measurement representing the response to the...