Designs for phase I clinical trials with multiple courses of subjects at different doses

Fan, Shenghua K. and Wang, You-Gan (2007) Designs for phase I clinical trials with multiple courses of subjects at different doses. Biometrics, 63 3: 856-864. doi:10.1111/j.1541-0420.2007.00772.x


Author Fan, Shenghua K.
Wang, You-Gan
Title Designs for phase I clinical trials with multiple courses of subjects at different doses
Journal name Biometrics   Check publisher's open access policy
ISSN 0006-341X
1541-0420
Publication date 2007-09-01
Sub-type Article (original research)
DOI 10.1111/j.1541-0420.2007.00772.x
Open Access Status Not Open Access
Volume 63
Issue 3
Start page 856
End page 864
Total pages 9
Place of publication Oxford, United Kingdom
Publisher Wiley-Blackwell Publishing
Language eng
Abstract The goal of this article is to provide a new design framework and its corresponding estimation for phase I trials. Existing phase I designs assign each subject to one dose level based on responses from previous subjects. Yet it is possible that subjects with neither toxicity nor efficacy responses can be treated at higher dose levels, and their subsequent responses to higher doses will provide more information. In addition, for some trials, it might be possible to obtain multiple responses (repeated measures) from a subject at different dose levels. In this article, a nonparametric estimation method is developed for such studies. We also explore how the designs of multiple doses per subject can be implemented to improve design efficiency. The gain of efficiency from “single dose per subject” to “multiple doses per subject” is evaluated for several scenarios. Our numerical study shows that using “multiple doses per subject” and the proposed estimation method together increases the efficiency substantially.
Keyword Dose finding
Estimation efficiency
Fisher information
Isotonic regression
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Mathematics and Physics
 
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Created: Wed, 17 Nov 2010, 23:49:10 EST