Skip to content Skip to navigation
University of Warwick
  • Study
  • |
  • Research
  • |
  • Business
  • |
  • Alumni
  • |
  • News
  • |
  • About

University of Warwick
Publications service & WRAP

Highlight your research

  • WRAP
    • Home
    • Search WRAP
    • Browse by Warwick Author
    • Browse WRAP by Year
    • Browse WRAP by Subject
    • Browse WRAP by Department
    • Browse WRAP by Funder
    • Browse Theses by Department
  • Publications Service
    • Home
    • Search Publications Service
    • Browse by Warwick Author
    • Browse Publications service by Year
    • Browse Publications service by Subject
    • Browse Publications service by Department
    • Browse Publications service by Funder
  • Help & Advice
University of Warwick

The Library

  • Login
  • Admin

Dose selection in seamless phase II/III clinical trials based on efficacy and safety

Tools
- Tools
+ Tools

Kimani, Peter K., Stallard, Nigel and Hutton, Jane (2009) Dose selection in seamless phase II/III clinical trials based on efficacy and safety. Statistics in Medicine, Vol.28 (No.6). pp. 917-936. doi:10.1002/sim.3522

Research output not available from this repository, contact author.
Official URL: http://dx.doi.org/10.1002/sim.3522

Request Changes to record.

Abstract

Seamless phase II/III clinical trials are attractive in development of new drugs because they accelerate the drug development process. Seamless phase II/III trials are carried out in two stages. After stage I (phase II stage), an interim analysis is performed and a decision is made on whether to proceed to stage 2 (phase III stage). If the decision is to continue with further testing, some dose-selection procedure is used to determine the set of doses to be tested in stage 2. In this paper, we propose a dose-selection procedure for binary outcomes in adaptive seamless phase II/III clinical trials that incorporates the dose-response relationship when the experimental treatments are different dose levels of the same drug, and explicitly incorporates both efficacy and safety. The choice of the doses to continue to stage 2 is made by comparing the predictive power of the potential sets of doses, which might continue. Copyright (C) 2009 John Wiley & Sons, Ltd.

Item Type: Journal Article
Subjects: Q Science > QA Mathematics
R Medicine
R Medicine > RM Therapeutics. Pharmacology
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Science > Statistics
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Medicine -- Statistics, Clinical trials, Clinical trials -- Methodology, Drug development, Drugs -- Effectiveness -- Research
Journal or Publication Title: Statistics in Medicine
Publisher: John Wiley & Sons Ltd.
ISSN: 0277-6715
Official Date: 15 March 2009
Dates:
DateEvent
15 March 2009Published
Volume: Vol.28
Number: No.6
Number of Pages: 20
Page Range: pp. 917-936
DOI: 10.1002/sim.3522
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Funder: University of Warwick

Data sourced from Thomson Reuters' Web of Knowledge

Request changes or add full text files to a record

Repository staff actions (login required)

View Item View Item
twitter

Email us: wrap@warwick.ac.uk
Contact Details
About Us