Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework

被引:4331
作者
Atkinson, AJ
Colburn, WA
DeGruttola, VG
DeMets, DL
Downing, GJ
Hoth, DF
Oates, JA
Peck, CC
Schooley, RT
Spilker, BA
Woodcock, J
Zeger, SL
机构
[1] NIH, Off Sci Policy, Bethesda, MD 20892 USA
[2] NIH, Warren G Magnuson Clin Ctr, Bethesda, MD 20892 USA
[3] MDS Harris Inc, Phoenix, AZ USA
[4] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
[5] Univ Wisconsin, Dept Biostat, Madison, WI USA
[6] Axys Pharmaceut, San Francisco, CA USA
[7] Vanderbilt Univ, Dept Med, Nashville, TN USA
[8] Georgetown Univ, Ctr Drug Dev Sci, Washington, DC USA
[9] Univ Colorado, Hlth Sci Ctr, Dept Med, Denver, CO 80262 USA
[10] Pharmaceut Res & Manufacturers Amer, Washington, DC USA
[11] US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
[12] Johns Hopkins Univ, Sch Hyg & Publ Hlth, Dept Biostat, Baltimore, MD 21205 USA
关键词
D O I
10.1067/mcp.2000.113989
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:89 / 95
页数:7
相关论文
共 30 条
[11]   A CONTROLLED TRIAL OF INTERFERON-GAMMA TO PREVENT INFECTION IN CHRONIC GRANULOMATOUS-DISEASE [J].
EZEKOWITZ, RAB .
NEW ENGLAND JOURNAL OF MEDICINE, 1991, 324 (08) :509-516
[12]   Surrogate end points in clinical trials: Are we being misled? [J].
Fleming, TR ;
DeMets, DL .
ANNALS OF INTERNAL MEDICINE, 1996, 125 (07) :605-613
[13]  
FLEMING TR, 1998, ENCY BIOSTATISTICS, V6, P4425
[14]   SLOW RECOVERY OF HUMAN BRAIN MAO-B AFTER L-DEPRENYL (SELEGELINE) WITHDRAWAL [J].
FOWLER, JS ;
VOLKOW, ND ;
LOGAN, J ;
WANG, GJ ;
MACGREGOR, RR ;
SCHLYER, D ;
WOLF, AP ;
PAPPAS, N ;
ALEXOFF, D ;
SHEA, C ;
DORFLINGER, E ;
KRUCHOWY, L ;
YOO, K ;
FAZZINI, E ;
PATLAK, C .
SYNAPSE, 1994, 18 (02) :86-93
[15]   STATISTICAL VALIDATION OF INTERMEDIATE END-POINTS FOR CHRONIC DISEASES [J].
FREEDMAN, LS ;
GRAUBARD, BI ;
SCHATZKIN, A .
STATISTICS IN MEDICINE, 1992, 11 (02) :167-178
[16]  
HUGHES MD, 1995, J ACQ IMMUN DEF SYND, V10, pS1
[17]   SURROGATE MARKERS IN AIDS - WHERE ARE WE - WHERE ARE WE GOING [J].
LAGAKOS, SW ;
HOTH, DF .
ANNALS OF INTERNAL MEDICINE, 1992, 116 (07) :599-601
[18]  
Lin DY, 1997, STAT MED, V16, P1515, DOI 10.1002/(SICI)1097-0258(19970715)16:13<1515::AID-SIM572>3.0.CO
[19]  
2-1
[20]   NEW MOLECULAR END-POINTS AND METHODS FOR ROUTINE TOXICITY TESTING [J].
MACGREGOR, JT ;
FARR, S ;
TUCKER, JD ;
HEDDLE, JA ;
TICE, RR ;
TURTELTAUB, KW .
FUNDAMENTAL AND APPLIED TOXICOLOGY, 1995, 26 (02) :156-173