Statistical issues for HIV surrogate endpoints: point/counterpoint. An NIAID workshop

This paper summarizes the proceedings of an NIAID-sponsored workshop on statistical issues for HIV surrogate endpoints. The workshop brought together statisticians and clinicians in an attempt to shed light on some unresolved issues in the use of HIV laboratory markers (such as HIV RNA and CD4+ cell...

Full description

Saved in:
Bibliographic Details
Published in:Statistics in medicine 1998-11, Vol.17 (21), p.2435-2462
Main Authors: Albert, J M, Ioannidis, J P, Reichelderfer, P, Conway, B, Coombs, R W, Crane, L, Demasi, R, Dixon, D O, Flandre, P, Hughes, M D, Kalish, L A, Larntz, K, Lin, D, Marschner, I C, Muñoz, A, Murray, J, Neaton, J, Pettinelli, C, Rida, W, Taylor, J M, Welles, S L
Format: Article
Language:English
Subjects:
AIDS/HIV
Biomarkers
CD4 Lymphocyte Count
Disease Progression
HIV - genetics
HIV Infections - diagnosis
HIV Infections - therapy
Human immunodeficiency virus
Humans
Models, Statistical
Proportional Hazards Models
RNA, Viral - analysis
Statistics as Topic
Treatment Outcome
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This paper summarizes the proceedings of an NIAID-sponsored workshop on statistical issues for HIV surrogate endpoints. The workshop brought together statisticians and clinicians in an attempt to shed light on some unresolved issues in the use of HIV laboratory markers (such as HIV RNA and CD4+ cell counts) in the design and analysis of clinical studies and in patient management. Utilizing a debate format, the workshop explored a series of specific questions dealing with the relationship between markers and clinical endpoints, and the choice of endpoints and methods of analysis in clinical studies. This paper provides the position statements from the two debaters on each issue. Consensus conclusions, based on the presentations and discussion, are outlined. While not providing final answers, we hope that these discussions have helped clarify a number of issues, and will stimulate further consideration of some of the highlighted problems. These issues will be critical in the proper assessment and use of future therapies for HIV disease.
ISSN:0277-6715