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An investigation of the traditional algorithm-based designs for phase 1 cancer clinical trials

Title
An investigation of the traditional algorithm-based designs for phase 1 cancer clinical trials
Authors
Kang S.-H.Ahn C.W.
Ewha Authors
강승호
Issue Date
2002
Journal Title
Drug Information Journal
ISSN
0092-8615JCR Link
Citation
vol. 36, no. 4, pp. 865 - 873
Indexed
SCOPUS WOS scopus
Abstract
The primary aim of a phase 1 cancer clinical trial is to determine the maximum tolerated dose of a new drug. Although the continual reassessment method is shown to have better operating characteristics than traditional designs, traditional designs are still widely used in practice. Kang and Ahn (1) developed an algorithm to compute the exact distribution of the maximum tolerated dose (MTD) in traditional designs with dose deescalation and investigated the expected toxicity rate at the MTD with the algorithm. In this paper, using the exact formulae derived by Lin and Shih (2), we study the expected toxicity rate at the MTD and the expected number of patients with toxicity and patients required when the hyperbolic tangent and the logistic functions are used as the unknown dose-toxicity curves. We consider the expected toxicity rate both without and with dose deescalation. No further study was done before in cases where dose level zero is chosen as the MTD. Since, in real practice, dose levels are lowered for adjustment and a new trial is conducted when dose level zero is decided as the MTD, we also incorporate this dose adjustment.
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자연과학대학 > 통계학전공 > Journal papers
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