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World J Methodol. Jun 26, 2014; 4(2): 109-122
Published online Jun 26, 2014. doi: 10.5662/wjm.v4.i2.109
Published online Jun 26, 2014. doi: 10.5662/wjm.v4.i2.109
Choosing inclusion criteria that minimize the time and cost of clinical trials
Charles F Babbs, Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN 47907, United States
Author contributions: Babbs CF was the sole author and contributor to this paper.
Correspondence to: 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
Telephone: +1-765-4942995 Fax: +1-765-4941193
Received: November 14, 2013
Revised: February 13, 2014
Accepted: April 16, 2014
Published online: June 26, 2014
Revised: February 13, 2014
Accepted: April 16, 2014
Published online: June 26, 2014
Core Tip
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.