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THE CHOICE OF PHASE I BAYESIAN ADAPTIVE DESIGNS IN CHINA

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Author(s): PAN H. | JI Y. | CHEN Z. | LI C. | XIA J.

Journal: International Journal of Drug Discovery
ISSN 0975-4423

Volume: 5;
Issue: 1;
Start page: 185;
Date: 2013;
Original page

Keywords: Phase-I design | Bayesian Adaptive design | China's clinical trial

ABSTRACT
China is new to Bayesian adaptive designs. In Phase I, all designs are adaptive and Bayesian designs have been heavily researched and implemented in US. However, in China, especially inland areas, there ordinarily lacks logistical foundations and sufficient numbers of qualified biostatisticans to equip clinical trials with advanced designs. This paper focuses on the phase I oncology studies and explores the performance, practical issues, and potential usability of two Bayesian designs: the continual reassessment method (CRM ) and the modified toxic probability interval (mTPI) design. We conclude that both designs provide desirable operating characteristics but the mTPI design is more suitable for China due to its transparency and simplicity. For example, mTPI does not require real-time online trial conduct tools that are otherwise needed to implement CRM. In addition, we propose a minor modification of the original mTPI that results in a sample size reduction compared to the original mTPI method.
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