alexa Analysis of Two-Stage Adaptive Seamless Trial Design
ISSN : 2153-2435

Pharmaceutica Analytica Acta
Open Access

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Review Article

Analysis of Two-Stage Adaptive Seamless Trial Design

Chow SC1* and Lin M2

1Duke University School of Medicine, Durham, North Carolina, USA

2Food and Drug Administration, Silver Spring, Maryland, USA

*Corresponding Author:
Chow SC
Department of Biostatistics
and Bioinformatics, Duke University School
of Medicine, 2424 Erwin Road, Hock Suite 1102
Room 11068, Durham, NC, USA
Tel: 919-668-7523
E-mail: [email protected]

Received date: January 22, 2015; Accepted date: February 21, 2015; Published date: February 28, 2015

Citation: Chow SC, Lin M (2015) Analysis of Two-Stage Adaptive Seamless Trial Design. Pharm Anal Acta 6:341. doi: 10.4172/2153-2435.1000341

Copyright: © 2015 Chow SC, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



In the past decade, adaptive design methods in clinical research have attracted much attention because it offers the principal investigators (1) potential flexibility for identifying clinical benefit of a test treatment under investigation, but efficiency for speeding up the development process. One of the most commonly considered adaptive designs is probably a two-stage seamless (e.g., phase I/II or phase II/III) adaptive design. The two-stage seamless adaptive designs can be classified into four categories depending upon study objectives and study endpoints at different stages. These categories include (I) design with same study objectives and study endpoints at different stages, (II) designs with same study objectives but different study endpoints at different stages, (III) designs with different study objectives but same study endpoints at different stages, and (IV) designs with different study objectives and different study endpoints at different stages. In this article, an overview of statistical methods for analysis of these different types of two-stage designs is provided. In addition, a case study concerning the evaluation of a test treatment for treating hepatitis C infected patients utilizing type (IV) trial design is presented.

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