Pharmaceutical Statistics Using SAS

10.4. A Classical Power Analysis

Dr. Capote and his team plan their trial as follows.

Study Design

This trial follows the small (N = 62 + 62) DCA trial reported by Agbenyega et al. (2003). It will be double-blind, but instead of a 1:1 allocation, the team would like to consider giving one patient usual care only for every two patients that get QCA, where the QCA is given in a single infusion of 50 mg/kg.

Subjects

Study patients will be less than 13 years old with severe malaria complicated by lactic acidosis. "Untreatable' cases (nearly certain to die) will be excluded. These terms will require operational definitions and the CHI team will formulate the other inclusion/exclusion criteria and state them clearly in the protocol. They think it ...