TR Fleming, DL DeMets - Annals of Internal Medicine, 1996 - Am Coll Physicians Phase 3 clinical trials, which evaluate the effect that new interventions have on the clinical outcomes
of particular relevance to the patient (such as death, loss of vision, or other major symptomatic
event), often require many participants to be followed for a long time.There has recently ... Cited by 756 - Related articles - BL Direct - All 9 versions
RL Prentice… - Stat Med, 1989 - psg-mac43.ucsf.edu 432 RL PRENTICE Sii endpoint measurement may be unduly invasive, uncomfortable or
expensive, so lhal we may intentionally permit a degree of measurement error regarding the
timing or e ven the occurrence of a true endpoint event. Furthermore, both Ellcnberg and ... Cited by 722 - Related articles - All 4 versions
LS Freedman, BI Graubard, A Schatzkin - Stat Med, 1992 - interscience.wiley.com We discuss the implementation of a criterion due to Prentice for the statistical validation of intermediate
endpoints for chronic disease. The criterion involves examining in a cohort or intervention study
whether an exposure or intervention effect, adjusted for the intermediate endpoint, is ... Cited by 278 - Related articles - All 3 versions
- ►unc.edu [PDF] V De Gruttola, T Fleming, DY Lin, R Coombs - The Journal of infectious diseases, 1997 - jstor.org Perspective: Validating Surrogate Markers?Are We Being Naive? ... V. De Gruttola, T.
Fleming, DY Lin, and R. Coombs Department of Biostatistics, Harvard School of Public
Health, Boston, Massachusetts; Department of Biostatistics, University of Washington, and ... Cited by 114 - Related articles - BL Direct - All 4 versions
[CITATION] 1 A REGULATORY AUTHORITY'S OPINION ABOUT SURROGATE ENDPOINTS
M Buyse, G Molenberghs - Biometrics, 1998 - jstor.org SUMMARY The validation of surrogate endpoints has been studied by Prentice (1989, Statistics
in Medicine 8, 431-440) and Freedman, Graubard, and Schatzkin (1992, Statistics in Medicine
11, 167-178). We extend their proposals in the cases where the surrogate and the final ... Cited by 174 - Related articles - BL Direct - All 7 versions
MJ Daniels, MD Hughes - Statistics in Medicine, 1997 - interscience.wiley.com We describe a meta-analysis approach for the evaluation of a potential surrogate marker. Surrogate
markers are useful in helping to identify therapeutic mechanisms of action and disease
pathogenesis, and for selecting therapies to take forward from phase II to phase III clinical ... Cited by 143 - Related articles - BL Direct - All 3 versions
DY Lin, TR Fleming, V De Gruttola - Statistics in Medicine, 1997 - psg-mac43.ucsf.edu In this paper, we measure the extent to which a biological marker is a surrogate endpoint for
a clinical event by the proportional reduction in the regression coefficient for the treatment indicator
due to the inclusion of the marker in the Cox regression model. We estimate this ... Cited by 134 - Related articles - View as HTML - BL Direct - All 7 versions
- ►oxfordjournals.org [PDF] M Buyse, G Molenberghs, T Burzykowski, D Renard, H … - Biostatistics, 2000 - Biometrika Trust Page 1. Printed in Great Britain Biostatistics (2000), 1, 1, pp. 49–67 The validation of surrogate
endpoints in meta-analyses of randomized experiments M. BUYSE International Institute for Drug
Development, 430 avenue Louise B14, B1050 Brussels, Belgium mbuyse@id2.be ... Cited by 147 - Related articles - BL Direct - All 7 versions
TR Fleming - Statistics in medicine, 1994 - interscience.wiley.com There is significant need for rapid yet reliable evaluation of promising new interventions for the
treatment of patients with cancer or HIV infection. Considerable attention has been given to identifying
replacement or surrogate endpoints for the true clinical efficacy endpoints, in order to ... Cited by 66 - Related articles - BL Direct - All 4 versions
