       Document 0597
 DOCN  M9610597
 TI    Evaluating surrogate markers.
 DT    9601
 AU    Hughes MD; DeGruttola V; Welles SL; Department of Biostatistics, Harvard
       School of Public Health,; Boston, MA 02115, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S1-8. Unique
       Identifier : AIDSLINE MED/96033806
 AB    We discuss approaches for efficiently evaluating potential surrogate
       markers; in particular, we focus on case-cohort designs in which marker
       evaluation is undertaken only for a random sample of subjects within a
       randomized trial and for all other subjects who develop a major clinical
       outcome. These designs will be useful in clinical trials in which a
       highly significant treatment difference on clinical outcome has been
       obtained. In addition, we describe a method for using data from all
       available studies using a meta-analysis to explore the association of
       treatment effects on the potential marker and on clinical outcome. This
       may be the most effective approach for marker evaluation because it uses
       data from both large and small trials and incorporates information from
       trials in which nonsignificant treatment differences on the major
       clinical outcome are obtained.
 DE    *Biological Markers  Case-Control Studies  Cohort Studies  CD4
       Lymphocyte Count  Human  HIV Infections/*IMMUNOLOGY/THERAPY
       Meta-Analysis  Randomized Controlled Trials  Support, Non-U.S. Gov't
       Support, U.S. Gov't, P.H.S.  Treatment Outcome  JOURNAL ARTICLE  REVIEW
       REVIEW, TUTORIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

