Issue
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Original article
Practical midcourse sample size modification in clinical trials Michael A. Proschan, Qing Liu, Sally Hunsberger pages 4-15 Abstract | Full Text | Full-Text PDF (104 KB)
Unique roles of a data and safety monitoring board in vaccine safety trials with compressed timelines and urgent implications David Scheifele, Bernard Duval, Gaston De Serres, Danuta M Skowronski pages 99-104 Abstract | Full Text | Full-Text PDF (94 KB)
Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial Adele M.Kaplan Gilpin, Janet T Holbrook, Douglas A Jabs, Curtis L Meinert, for the Studies of Ocular Complications of AIDS Research Group pages 92-98 Abstract | Full Text | Full-Text PDF (123 KB)
Termination of a randomized controlled trial of two vasectomy techniques Mario Chen-Mok, Shrikant I Bangdiwala, Rosalie Dominik, Melissa Hays, Belinda Irsula, David C Sokal pages 78-84 Abstract | Full Text | Full-Text PDF (103 KB)
Data and safety monitoring board issues raised in the VA Status Epilepticus Study Joseph F Collins pages 71-77 Abstract | Full Text | Full-Text PDF (126 KB)
Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization Keith Wheatley, David Clayton pages 66-70 Abstract | Full Text | Full-Text PDF (117 KB)
Book review
Data Monitoring Committees in Clinical Trials: A Practical Perspective. S.S. Ellenberg, T.R. Fleming, and D.L. DeMets; John Wiley & Sons, Chichester, 2002, 191 pages. (hardbound. ISBN 0-471-48986-7 U.S. $74.95) Patricia M Grambsch pages 105-106 Full Text | Full-Text PDF (67 KB)
Stopping the active intervention: CARET Deborah J Bowen, Mark Thornquist, Karen Anderson, Matt Barnett, Corinne Powell, Gary Goodman, Gilbert Omenn pages 39-50 Abstract | Full Text | Full-Text PDF (1317 KB)
A model for the interim analysis process: a case study Leticia Delgado-Herrera, Dan Anbar pages 51-65 Abstract | Full Text | Full-Text PDF (156 KB)
Statistical issues related to early closure of STOP-ROP, a group-sequential trial Neal L Oden, Dale L Phelps, on behalf of the STOP-ROP Multicenter Study Group pages 28-38 Abstract | Full Text | Full-Text PDF (187 KB)
DSMB case study: decision making when a similar clinical trial is stopped early David W Hillman, Thomas A Louis pages 85-91 Abstract | Full Text | Full-Text PDF (112 KB)
List of reviewer
List of Reviewers pages 107-108 Full Text | Full-Text PDF (37 KB)
Call for paper
Call for short case reports on follow-up in clinical trials James D. Neaton, Editor-in-Chief page 1 Full-Text PDF (47 KB)
Preface
Preface James D Neaton, Editor-in-Chief pages 2-3 Full Text | Full-Text PDF (62 KB)
Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis Y.H.Joshua Chen, David L. DeMets, K.K.Gordon Lan pages 16-27 Abstract | Full Text | Full-Text PDF (95 KB)
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