Publication Name	World Journal of Methodology
Manuscript ID	7350
Country	United States

Received	2013-11-14 08:23
Peer-Review Started	2013-11-15 10:50
To Make the First Decision	2014-01-15 16:31
Return for Revision	2014-01-20 16:16
Revised
Second Decision	2014-04-16 17:10
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief	2014-04-16 17:20
Articles in Press	2014-05-23 12:27
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript	2014-07-17 13:38
Publish the Manuscript Online	2014-08-20 20:59

ISSN	2222-0682 (online)
Open Access
Copyright
Article Reprints	For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
Permissions	For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
Publisher	Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Website	http://www.wjgnet.com

Category	Mathematical & Computational Biology
Manuscript Type	Autobiography
Article Title	Choosing inclusion criteria that minimize the time and cost of clinical trials
Manuscript Source	Invited Manuscript
All Author List	Charles F Babbs
Funding Agency and Grant Number
Corresponding Author	Charles F Babbs, MD, PhD, Weldon School of Biomedical Engineering, Purdue University, 206 S. Martin Jischke Drive, West Lafayette, IN 47907, United States. babbs@purdue.edu
Key Words	Adaptive trial designs; Biomarkers; Clinical trials; Device; Drug therapy; Ethics; Methodology; Optimal allocation; Personalized medicine; Sequential design
Core Tip	This paper presents statistical tools to model and optimize the cost of a randomized clinical trial as a function of the stringency of patient inclusion criteria. The patient numbers and total cost are strongly related to the choice of the cutoff for inclusion. Clear cost minimums exist for many realistic scenarios. Potential cost savings for typical trial scenarios range in millions of dollars. Early formal estimation of optimal inclusion criteria allows planning of clinical trials to avoid high costs, excessive delays, and moral hazards of type Ⅱ errors.
Publish Date	2014-08-20 20:59
Citation	Babbs CF. Choosing inclusion criteria that minimize the time and cost of clinical trials. World J Methodol 2014; 4(2): 109-122
URL	http://www.wjgnet.com/2222-0682/full/v4/i2/109.htm
DOI	http://dx.doi.org/10.5662/wjm.v4.i2.109

Full Article (PDF)	WJM-4-109.pdf
Full Article (Word)	WJM-4-109.doc
Manuscript File	7350-Review.doc
Answering Reviewers	7350-Answering reviewers.pdf
Copyright License Agreement	7350-Copyright assignment.pdf
Peer-review Report	7350-Peer review.pdf
Scientific Editor Work List	7350-Scientific editor work list.doc