Statistical Methods For Drug Data Analysis

In clinical trials, statistical considerations of the analytic process include the eligibility criteria, randomization, treatment regimens (e.g., dose level, schedule, and treatment duration), sample size estimation (justification and/or re-estimation), planned schedule of patient evaluations for data collection (e.g., number of intermediate time points, timing of last patient observation and duration of patient study participation), primary study endpoint (e.g., which of several types of outcome assessments, which time point of assessment, use of a unitary versus composite endpoint or the components included in a composite endpoint, secondary endpoints, analytic methods to evaluate the endpoints (e.g., covariates of final analysis, statistical methodology, Type I error control), the criteria for efficacy and safety assessment, possible interim analysis and data monitoring, and statistical and clinical inference. By defining response variables (or clinical endpoints), efficacy and safety can be clearly indicated. Vs Chow SC, A Note on Design and Analysis of Clinical Trials.

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Last date updated on April, 2024