1. Analysis of Nonrandomly Censored Ordered Categorical Longitudinal Data from Analgesic Trials
- Author
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Adrian Dunne, Stuart L. Beal, and Lewis B. Sheiner
- Subjects
Statistics and Probability ,medicine.medical_specialty ,business.industry ,Analgesic ,Marginal model ,Missing data ,Random effects model ,Placebo ,Clinical trial ,Statistics ,Physical therapy ,medicine ,Dosing ,Statistics, Probability and Uncertainty ,business ,Categorical variable - Abstract
A clinical trial of an analgesic agent compares pain relief scores over time among groups of patients. All subjects experience the same painful procedure, but different subjects are given different randomly assigned doses of active agent or placebo when they first request it. The data are short individual time series of ordered categorical pain relief scores subsequent to dosing. Nonrandom right censoring may be present because patients can elect to remedicate with an active agent if their pain relief is insufficient. The trial is meant to address two questions: (a) Is there proof that the drug relieves pain? If so, (b) What dosage patterns should be investigated further, or recommended for use by a typical patient? Marginal models of human pharmacology are basically empirical models, and although an analysis of a study based on such a model can adequately address the first question, such is not the case for the second question, because this question requires extrapolation to untested dosing patt...
- Published
- 1997