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).