Statistical and practical considerations in planning and conduct of dose-optimization trials

This article provides a comprehensive review of various design strategies for dose-optimization trials, including phase 1/2 and 2/3 designs, and highlights their respective advantages and disadvantages. In addition, practical considerations for selecting an appropriate design and planning and executing the trial are discussed. The article also presents freely available software tools that can be utilized for designing and implementing dose-optimization trials. The approaches and their implementation are illustrated through real-world examples.PMID:38243399 | DOI:10.1177/17407745231207085
Source: Clinical Trials - Category: Research Authors: Source Type: research