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An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

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Stallard, Nigel. (2011) An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information. Trials, Vol.12 (Suppl.1). A2. ISSN 1745-6215

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Official URL: http://dx.doi.org/10.1186/1745-6215-12-S1-A2

Abstract

Adaptive seamless phase II/III designs enable a clinical
trial to be conducted in stages with the most promising
of a number of experimental treatments selected on the
basis of data observed in the first stage to continue
along with the control treatment to the second and any
subsequent stages.

Item Type:

Journal Article

Subjects:

R Medicine > R Medicine (General)

Divisions:

Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School

Library of Congress Subject Headings (LCSH):

Clinical trials -- Design

Journal or Publication Title:

Trials

Publisher:

Bio Med Central

ISSN:

1745-6215

Official Date:

13 December 2011

Dates:

Date	Event
13 December 2011	Published

Volume:

Vol.12

Number:

Suppl.1

Page Range:

Identification Number:

10.1186/1745-6215-12-S1-A2

Status:

Peer Reviewed

Publication Status:

Published

Access rights to Published version:

Open Access

Description:

Oral presentation at Clinical Trials Methodology Conference 2011, Bristol, UK. 4-5 October 2011

References:

1. Stallard N: A confirmatory seamless phase II/III clinical trial design
incorporating short-term endpoint information. Statistics in Medicine 2010,
29:959-971.
2. Galbraith S, Marschner IC: Interim analysis of continuous long-term
endpoints in clinical trials with longitudinal outcomes. Statistics in
Medicine 2003, 22:1787-1805.
3. Jennison C, Turnbull BW: Group-sequential analysis incorporating
covariate information. Journal of the American Statistical Association 1997,
92:1330-1341.
4. Stallard N, Todd S: Sequential designs for phase III clinical trials
incorporating treatment selection. Statistics in Medicine 2003, 22:689-703.
5. Engel B, Walstra P: Increasing precision or reducing expense in regression
experiments by using information from a concomitant variable.
Biometrics 1991, 47:13-20.

URI:

http://wrap.warwick.ac.uk/id/eprint/42346

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