Sample-Size Software for Ordered Categorical Data

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1 R43 CA65358-1,
Agency Tracking Number: 24927
Amount: $375,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1997
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Cytel Software Corp.
675 Massachusetts Avenue, Cambridge, MA, 02139
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Cyrus Mehta
 (617) 661-2011
Business Contact
Phone: () -
Research Institution
Ordered categorical variables arise frequently in cancer clinical trials and other biomedicalstudies. The statistical procedures for analyzing such data are well known and software for performingthe analysis is readily available. The basic idea is to condition on the margins of the contingency tablecreated by the categorical data and thereby obtain a distribution free test that automatically corrects forties. Despite the popularity of this conditional approach for analyzing ordered categorical data there hasbeen very little work done on power and sample-size considerations at the design phase. A biomedicalinvestigator about to launch a clinical trial for comparing two treatments with ordered categoricaloutcomes will find it extremely difficult to determine what sample size is needed. Either the investigatormust assume that the data are continuous, or else that the data are binary, since these are the onlycases for which reliable methods and software are available. Both approaches are inappropriate forordered categorical data. We propose to fill the void by providing new exact and Monte Carlo methodsthat provide accurate power and sample-size estimates for conditional tests on ordered categorical data.

* information listed above is at the time of submission.

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