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M9490020.TXT
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1994-09-03
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Document 0020
DOCN M9490020
TI Surrogate and auxiliary endpoints in clinical trials, with potential
applications in cancer and AIDS research.
DT 9411
AU Fleming TR; Prentice RL; Pepe MS; Glidden D; Department of
Biostatistics, University of Washington, Seattle; 98195.
SO Stat Med. 1994 May 15;13(9):955-68. Unique Identifier : AIDSLINE
MED/94323613
AB Surrogate endpoints have been defined by Prentice as response variables
that can substitute for a 'true' endpoint for the purpose of comparing
specific interventions or treatments in a clinical trial. The
applicability of this definition, and of related surrogate endpoint
criteria, is discussed, with emphasis on cancer and AIDS research
settings. Auxiliary endpoints are defined as response variables, or
covariates, that can strengthen true endpoint analyses. Specifically,
such response variables provide some additional information on true
endpoint occurrence times for study subjects having censored values for
such times. Auxiliary variables will very frequently be available, and
they may be able to be used without making additional strong
assumptions. Approaches to the use of auxiliary variables using ideas
based on augmented score and augmented likelihood methods are described.
DE Acquired Immunodeficiency Syndrome/MORTALITY/PREVENTION & CONTROL/
*THERAPY Antineoplastic Agents, Combined/THERAPEUTIC USE Chemotherapy,
Adjuvant Clinical Trials/*STATISTICS & NUMER DATA Colonic
Neoplasms/DRUG THERAPY/MORTALITY/PATHOLOGY Combined Modality Therapy
*Data Interpretation, Statistical Fluorouracil/ADMINISTRATION & DOSAGE
Human Levamisole/ADMINISTRATION & DOSAGE Likelihood Functions
*Models, Statistical Neoplasm Staging Neoplasms/MORTALITY/PREVENTION &
CONTROL/*THERAPY Randomized Controlled Trials/*STATISTICS & NUMER DATA
Research Support, U.S. Gov't, P.H.S. Survival Analysis Treatment
Outcome JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).