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4. A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study.

Author

Ming Zhou and Shen, Larry Z.

Subjects
DECISION making methodology, STATISTICS methodology, ALGORITHMS, CLINICAL trials, CONFIDENCE intervals, DECISION trees, EXPERIMENTAL design, DRUG development, SAMPLE size (Statistics), NULL hypothesis
Abstract

The article discusses the necessity of conducting a definite go/no-go study before making a major investment (phase 3) on a newly developed drug. Topics covered include conducting a study or review of a probable occurrence of an adverse event from previous studies, checking if a dose-limiting adverse event may have occurred that could affect patient tolerance to the drug, and validating a delivery medical device that may have an unacceptable failure rate.

Published
2014
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