Controlled Clinical Trials 2001: Vol 22 Table of Contents

7 Pages·2001·1.6 MB·English

Controlled Clinical Trials
DESIGN, METHODS, AND ANALYSIS
Official Journal of the Society for Clinical Trials
Volume 22, Number 1, 2001
Contents
Call for Papers
Original Articles
KEN KLEINMAN
Adaptive Double Data Entry: A Probabilistic Tool for Choosing Which
Forms to Reenter
STEVEN FOLMAR, FLORIA OATES-WILLIAMS, PENNY SHARP,
DAVID REBOUSSIN, JACKI SMITH, KAY CHESHIRE, JUDITH MACER,
KAREN POTVIN KLEIN, AND DAVID HERRINGTON
Recruitment of Participants for the Estrogen Replacement and Atherosclerosis
(ERA) Trial: A Comparison of Costs, Yields, and Participant Characteristics from
Community- and Hospital-Based Recruitment Strategies
Invited Papers on Closeout Issues
JAMES D. NEATON
Preface
SARA L. PRESSEL, BARRY R. DAVIS, JACKSON T. WRIGHT, JR.,
THERESE S. GERACI, CONNIE KINGRY, CHARLES E. FORD, LINDA B. PILLER,
JUDY BETTENCOURT, BARBARA KIMMEL, CHRISTINE LUSK,
HEATHER PARKS, LARA M. SIMPSON, CHUKE NWACHUKU, AND
CURT D. FURBERG, FOR THE ALLHAT COLLABORATIVE RESEARCH GROUP
Operational Aspects of Terminating the Doxazosin Arm of the Antihypertensive
and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
JORGE A. TAVEL AND LISA FOSDICK FOR THE ESPRIT VANGUARD GROUP
AND THE ESPRIT EXECUTIVE COMMITTEE
Closeout of Four Phase If Vanguard Trials and Patient Rollover into a Large
International Phase Ii] HIV Clinical Endpoint Trial
KATHERINE MUTH, EUNICE YU, BEVERLY ALSTON,
AND JONAS H. ELLENBERG
The Closeout Process for a Clinical Trial Terminated Early for Lagging Enrollment
and Inadequate Follow-up
GREG A. GRANDITS, RICHARD H. GRIMM, JR., RONALD J. PRINEAS,
PATRICIA GRAMBSCH, AND LESLIE A. HOLLAND
Obtaining Event Status at the Close of the Treatment of Mild Hypertension Study:
Methods and Implication for Other Trials
JANET T. HOLBROOK, CURTIS L. MEINERT, AND DOUGLAS A. JABS FOR THEI
STUDIES OF OCULAR COMPLICATIONS OF AIDS RESEARCH GROUP
Patient Notification and Follow-up after Suspension of Treatment Protocols:
Experience from Four Clinical Trials of Treatments for AIDS-Related CMV Retinitis
Letter to the Editor
Book Review
Design Papers
PAULA P. SCHNURR, MATTHEW J. FRIEDMAN, PHILIP W. LAVORI,
AND FRANK Y. HSIEH
Design of Department of Veterans Affairs Cooperative Study No. 420:
Group Treatment of Posttraumatic Stress Disorder
HARM VAN TINTEREN, OTTO S. HOEKSTRA, EGBERT F. SMIT,
PAUL VERBOOM, AND MAARTEN BOERS ON BEHALF OF THE
PLUS STUDY GROUP
Toward Less Futile Surgery in Non-Small Cell Lung Cancer? A Randomized
Clinical Trial to Evaluate the Cost-Effectiveness of Positron Emission Tomography
List of Reviewers
Volume 22, Number 2, 2001
Call for Papers
Original Articles
RALF BENDER
Calculating Confidence Intervals for the Number Needed to Treat
JOACHIM HARTUNG
\ Self-Designing Rule for Clinical Trials with Arbitrary Response Variables
DANIEL J. SARGENT, VICTOR CHAN, AND RICHARD M. GOLDBERG
\ Three-Outcome Design for Phase II Clinical Trials
DENIS HENG-YAN LEUNG AND YOU-GAN WANG
Isotonic Designs for Phase I Trials
Commentary
DAVID FEIGAI
Who’s on First? What’s on Second?
Design Papers
LAURA M. SMEATON, VICTOR DEGRUTTOLA, GREGORY K. ROBBINS,
AND ROBERT W. SHAFER
ACTG (AIDS Clinical Trials Group) 384: A Strategy Trial Comparing
Consecutive Treatments for HIV-1
THE INITIO CO-ORDINATING COMMITTEE
An Open-Label Randomized Trial to Evaluate Different Therapeutic Strategies
of Combination Therapy in HIV-1 Infection: Design, Rationale, and Methods
of the Initio Trial
RODGER D. MAcARTHUR, LI CHEN, DOUGLAS L. MAYERS, C. LYNN BESCH,
RICHARD NOVAK, MARY VAN DEN BERG-WOLF, TERESA YURIK,
GRACE PENG, BARRY SCHMETTER, BARBARA BRIZZ, AND DONALD ABRAMS
FOR THE CPCRA 058 FIRST TRIAL STUDY TEAM
The Rationale and Design of the CPCRA (Terry Beirn Community Programs
for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus
Suppressive Therapies) Trial
Letters to the Editor
Book Reviews
Erratum
Volume 22, Number 2S, 2001
Supplement
Letter from the President
Calendar of Program
Abstracts: Twenty-second Annual Meeting of the Society for Clinical Trials
Author Index
Volume 22, Number 3, 2001
Contents
Original Articles
DARYL PULLMAN AND XIKUI WANG
Adaptive Designs, Informed Consent, and the Ethics of Research
WEI PAN
Sample Size and Power Calculations with Correlated Binary Data
ANDREW R. WILLAN
Analysis, Sample Size, and Power for Estimating Incremental Net Health Benefit
from Clinical Trial Data
ENRIQUE MENENDEZ, MARY CASTLE WHITE, AND JACQUELINE P. TULSKY
Locating Study Subjects: Predictors and Successful Search Strategies with Inmates
Released from a U.S. County Jail
THE COLLABORATIVE OCULAR MELANOMA STUDY GROUP, PREPARED BY
COMS MORTALITY CODING COMMITTEE: CLAUDIA S. MOY, DANIEL M. ALBERT,
MARIE DIENER-WEST, LEE D. MCCAFFREY, ROBERT E. SCULLY,
AND JAMES K.V. WILLSON
Cause-Specific Mortality Coding: Methods in the Collaborative Ocular Melanoma
Study COMS Report No. 14
Letters to the Editor
Book Reviews
Workshop Proceedings
SARA WILCOX, SALLY A. SHUMAKER, DEBORAH J. BOWEN,
MICHELLE J. NAUGHTON, MILAGROS C. ROSAL, SHARI E. LUDLAM,
ELIZABETH DUGAN, JULIE R. HUNT, AND STEPHANIE STEVENS
Promoting Adherence and Retention to Clinical Trials in Special Populations:
A Women’s Health Initiative Workshop
Design Papers
DANIEL H. LOWENSTEIN, BRIAN K. ALLDREDGE, FAITH ALLEN,
JOHN NEUHAUS, MEGAN CORRY, MILDRED GOTTWALD, NELDA O’NEIL,
SUEKAY ULRICH, S. MARSHAL ISAACS, AND ALLAN GELB
The Prehospital Treatment of Status Epilepticus (PHTSE) Study: Design
and Methodology
PETER GUARINO, PETER PEDUZZI, SAM T. DONTA, CHARLES C. ENGLE, JR.,
DANIEL J. CLAUW, DAVID A. WILLIAMS, JAMES S. SKINNER, ANDRE BARKHUIZEN,
LEWIS E. KAZIS, AND JOHN R. FEUSSNER FOR THE CSP #470 STUDY GROUP
A Multicenter Two by Two Factorial Trial of Cognitive Behavior Therapy and
Aerobic Exercise for Gulf War Veterans’ Illnesses: Design of a Veterans Affairs
Cooperative Study (CSP #470)
SEEMA MIHRSHAHL, JENNIFER K. PEAT, KAREN WEBB, EUAN R. TOVEY,
GUY B. MARKS, CRAIG M. MELLIS, AND STEPHEN R. LEEDER FOR THE CAPS TEAM
The Childhood Asthma Prevention Study (CAPS): Design and Research Protocol
of a Randomized Trial for the Primary Prevention of Asthma
Errata
Controlled Clinical Trials is cited in Behavioral Medicine Abstracts, Biological Abstracts, BIOMED Database, CABS/Current
Awarenes in Biological Sciences, Current Contents (Clinical Medicine), Current Contents (Life Sciences), Excerpta Medica
Index Medicus, Research Update, Research Alert SCISEARCH, and Science Citation Index.
Volume 22, Number 4, 2001
Original Articles
WEICHUNG JOE SHIH
Clinical Trials for Drug Registrations in Asian-Pacific Countries: Proposal for a
New Paradigm from a Statistical Perspective
SIN-HO JUNG, MARK CAREY, AND KYUNGMANN KIM
Graphical Search for Two-Stage Designs for Phase II Clinical Trials
KUNG-JONG LUI AND WILLIAM G. CUMBERLAND
Sample Size Determination for Equivalence Test Using Rate Ratio of Sensitivity
and Specificity in Paired-Sample Data
J. JACK LEE AND CHI-HONG TSENG
Uniform Power Method for Sample Size Calculation in Historical Control
Studies with Binary Response
Letter to the Editor
Book Review
Design Papers
ROMAIN A. PAUWELS, WILLIAM W. BUSSE, PAUL M. O’BYRNE,
SOREN PEDERSEN, WAN C. TAN, YU-ZHI CHEN,
STEFAN V. OHLSSON, AND ANDERS ULLMAN
The Inhaled Steroid Treatment as Regular Therapy in Early Asthma
(START) Study: Rationale and Design
SEAN D. SULLIVAN, BENGT LILJAS, MARTIN BUXTON, CARL JOHAN LAMM,
PAUL O'BYRNE, WAN C. TAN, AND KEVIN B. WEISS
Design and Analytic Considerations in Determining the Cost-Effectiveness of
Early Intervention in Asthma from a Multinational Clinical Trial
LAWRENCE H. MOULTON, KATHERINE L. O’BRIEN, ROBERT KOHBERGER,
IH CHANG, RAYMOND REID, ROBERT WEATHERHOLTZ, JILL G. HACKELL,
GEORGE R. SIBER, AND MATHURAM SANTOSHAM
Design of a Group-Randomized Streptococcus pneumoniae Vaccine Trial
JARED B. JOBE, DAVID M. SMITH, KARLENE BALL, SHARON L. TENNSTEDT,
MICHAEL MARSISKE, SHERRY L. WILLIS, GEORGE W. REBOK, JOHN N. MORRIS,
KARIN F. HELMERS, MARY D. LEVECK, AND KEN KLEINMAN
ACTIVE: A Cognitive Intervention Trial to Promote Independence in Older Adults
Announcement
Volume 22, Number 5, 2061
Original Articles
VICTOR G. DE GRUTTOLA, PAMELA CLAX, DAVID L. DEMETS,
GREGORY J. DOWNING, SUSAN S. ALLENBERG, LAWRENCE FRIEDMAN,
MITCHELL H. GAIL, ROSS PRENTICE, JANET WITTES, AND SCOTT L. ZEGER
Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials:
Summary of a National Institutes of Health Workshop
What Next?
VERONICA SEBILLE AND ERIC BELLISSANT
Comparison of the Two-Sided Single Triangular Test to the Double Triangular Test
JARL S. TORGERSON, KRISTER ARLINGER, MARCUS KAPPI,
AND LARS SJOSTROM
Principles for Enhanced Recruitment of Subjects in a Large Clinical Trial:
The XENDOS Study Experience
THE COLLABORATIVE OCULAR MELANOMA STUDY GROUP
Sociodemographic and Clinical Predictors of Participation in Two Randomized
Trials: Findings from the Collaborative Ocular
Melanoma Study COMS Report No. 7
LUC DUCHATEAU, JEAN PIERRE PIGNON, LUC BIJNENS, SYLVIE BERTIN,
JEAN BOURHIS, AND RICHARD SYLVESTER
Individual Patient- versus Literature-Based Meta-analysis of Survival Data: Time to
Event and Event Rate at a Particular Time Can Make a Difference, an Example
Based on Head and Neck Cancer
Letters to the Editor
Design Papers
YADON ARAD, DAVID NEWSTEIN, MARGUERITE ROTH, AND ALAN D. GUERCI
Rationale and Design of the St. Francis Heart Study: A Randomized Clinical
Trial of Atorvastatin Plus Antioxidants in Asymptomatic Persons with
Elevated Coronary Calcification
LESLIE HYMAN, JANE GWIAZDA, WENDY L. MARSH-TOOTLE,
THOMAS T. NORTON, MOHAMED HUSSEIN, AND THE COMET GROUP
The Correction of Myopia Evaluation Trial (COMET): Design and General
Baseline Characteristics
Volume 22, Number 6, 2001
Original Articles
RICHARD HORTON
he Clinical Trial: Deceitful, Disputable, Unbelievable, Unhelpful, and Shameful--
What Next?
LEMUEL A. MOYE AND ANITA DESWAI
[rials Within Trials: Confirmatory Subgroup Analysis in Controlled Clinical
Experiments
IKUKO TOYODA, YUTAKA MATSUYAMA, AND YASUO OHASHI
Estimation and Comparison of Rates of Change in Repeated-Measures Studies
with Planned Dropout
VALERIE JOURNOT, GENEVIEVE CHENE, PIERRE JOLY, MARIANNE SAVES,
HELENE JACQMIN-GADDA, JEAN-MICHEL MOLINA, ROGER SALAMON,
AND THE ALBI STUDY GROUP
Viral Load as a Primary Outcome in Human Immunodeficiency Virus Trials:
A Review of Statistical Analysis Methods
JACKSON T. WRIGHT, JR., WILLIAM C. CUSHMAN, BARRY R. DAVIS,
JOSHUA BARZILAY, PEDRO COLON, DEBRA EGAN, TRACY LUCENTE,
CHUKE NWACHUKU, SARA PRESSEL, FRANS H.H. LEENEN, JOSEPH FROLKIS,
REBECCA LETTERER, SANDRA WALSH, JONATHAN N. TOBIN, AND
GRANT E. DEGER FOR THE ALLHAT RESEARCH GROUP
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial
(ALLHAT): Clinical Center Recruitment Experience
SARA PRESSEL, BARRY R. DAVIS, GAIL T. LOUIS, PAUL WHELTON,
HORACIO ADROGUE. DEBRA EGAN, MICHAEL FARBER, GERALD PAYNE,
JEFFREY PROBSTFIELD, AND HARRY WARD, FOR THE ALLHAT RESEARCH GROUP
Participant Recruitment in the Antihypertensive and Lipid-Lowering Treatment to
Prevent Heart Attack (ALLHAT)
Letter to the Editox
Design Paper
STEVEN L. WOLF, RICHARD W. SATTIN, MICHAEL O’GRADY, NANA FRERET,
LOIS RICCI, ARLENE I. GREENSPAN, TINGSEN XU, AND MICHAEL KUTNER
A Study Design to Investigate the Effect of Intense Tai Chi in Reducing Falls
among Older Adults Transitioning to Frailty
Author Index
Subject Index
Volume Contents