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Adaptive Clinical Trial Designs for Phase I Cancer Studies

Sverdlov, Oleksandr, Wong, Weng Kee and Ryeznik, Yevgen (2014) Adaptive Clinical Trial Designs for Phase I Cancer Studies. Statistics surveys, 8. pp. 2-44. ISSN 1935-7516


Adaptive clinical trials are becoming increasingly popular research designs for clinical investigation. Adaptive designs are particularly useful in phase I cancer trials where clinical data are scant, and the goals are to assess the drug dose-toxicity profile and to determine the maximum tolerated dose while minimizing the number of study patients treated at suboptimal dose levels. In the current work we give a thorough overview of adaptive design methods for phase I cancer trials. We find that modern statistical literature is replete with novel adaptive designs that have clearly defined objectives and established statistical properties and are shown to outperform conventional dose finding methods such as the 3 + 3 design. We discuss statistical, logistical, and regulatory aspects of these designs and present some links to non-commercial statistical software for implementing these methods in practice.

Item Type: Article
Additional Information: This is an invited article for a volume "Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials and Design", prepared by Prof. N. Balakrishnan (McMaster University). The volume is planned to be put in production in Q3 2013.
Keywords: Bayesian designs, Continual reassessment method, Dose finding studies, Estimation eciency, Ethics, Maximum tolerated dose, Optimal designs, Phase I, Up-and-down designs
Date Deposited: 20 Jan 2024 00:46
Last Modified: 20 Jan 2024 00:46


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