TY - JOUR
T1 - NIAID Workshop, Memphis, Tennessee, 25-26 March 1997
T2 - Statistical issues for HIV surrogate endpoints: Point/counterpoint
AU - Albert, Jeffrey M.
AU - Ioannidis, John P.A.
AU - Reichelderfer, Patricia
AU - Conway, Brian
AU - Coombs, Robert W.
AU - Crane, Lawrence
AU - Demasi, Ralph
AU - Dixon, Dennis O.
AU - Flandre, Phillipe
AU - Hughes, Michael D.
AU - Kalish, Leslie A.
AU - Larntz, Kinley
AU - Lin, Danyu
AU - Marschner, Ian C.
AU - Muñoz, Alvaro
AU - Murray, Jeff
AU - Neaton, Jim
AU - Pettinelli, Carla
AU - Rida, Wasima
AU - Taylor, Jeremy M.G.
AU - Welles, Seth L.
PY - 1998/11/15
Y1 - 1998/11/15
N2 - 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.
AB - 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.
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U2 - 10.1002/(SICI)1097-0258(19981115)17:21<2435::AID-SIM994>3.0.CO;2-G
DO - 10.1002/(SICI)1097-0258(19981115)17:21<2435::AID-SIM994>3.0.CO;2-G
M3 - Article
C2 - 9819838
AN - SCOPUS:0032533023
SN - 0277-6715
VL - 17
SP - 2435
EP - 2462
JO - Statistics in Medicine
JF - Statistics in Medicine
IS - 21
ER -