Treatment selections using risk-benefit profiles based on data from comparative randomized clinical trials with multiple endpoints.

ABSTRACT: In a typical randomized clinical study to compare a new treatment with a control, oftentimes each study subject may experience any of several distinct outcomes during the study period, which collectively define the "risk-benefit" profile. To assess the effect of treatment, it is desirable to utilize the entirety of such outcome information. The times to these events, however, may not be observed completely due to, for example, competing risks or administrative censoring. The standard analyses based on the time to the first event, or individual component analyses with respect to each event time, are not ideal. In this paper, we classify each patient's risk-benefit profile, by considering all event times during follow-up, into several clinically meaningful ordinal categories. We first show h

SUBMITTER: Claggett B 

PROVIDER: S-EPMC4263228 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature