Table Of Content

Controlled Clinical Trials DESIGN, METHODS, AND ANALYSIS Official Journal of the Society for Clinical Trials Volume 14, Number 1, 1993 Contents STEPHEN SENN Suspended Judgment n-of-1 Trials MICHAEL S. SIMBERKOFF, PAMELA M. HARTIGAN, JOHN D. HAMILTON, DANIEL DEYKIN, MITCHELL GAIL, JOHN G. BARTLETT, PAUL FEORINO, ROBERT REDFIELD, RICHARD ROBERTS, DOROTHEA COLLINS, DAVID DEMETS, WILLIS PRITCHETT, NORTON SPRITZ, RICHARD P. WENZEL, AND THE VA COOPERATIVE STUDY GROUP ON AIDS TREATMENT, VA MEDICAL CENTER, NEW YORK, NEW YORK Ethical Dilemmas in Continuing a Zidovudine Trial After Early Termination of Similar Trials PAUL R. COE AND AJIT C. TAMHANE Exact Repeated Confidence Intervals for Bernoulli Parameters in a Group Sequential Clinical Trial CAROLYN SIEBERT Operational and Policy Considerations of Data Monitoring in Clinical Trials: The Diabetes Control and Complications Trial Experience DAVID WATERS, LYALL HIGGINSON, PETER GLADSTONE, BRIAN KIMBALL, MICHEL LEMAY, AND JACQUES LESPERANCE Design Features of a Controlled Clinical Trial to Assess the Effect of an HMG CoA Reductase Inhibitor on the Progression of Coronary Artery Disease Volume 14, Number 2, 1993 ALAN H. JOBE Suspended Judgment Simple Explanations for Complex Systems: Surprising and Unexpected Outcomes STEVEN D. MARK AND JAMES M. ROBINS A Method for the Analysis of Randomized Trials with Compliance Information: An Application to the Multiple Risk Factor Intervention Trial TERRY M. THERNEAU How Many Stratification Factors Are “Too Many” to Use ina Randomization Plan? JERRY HALPERN AND BYRON WM. BROWN JR. A Computer Program for Designing Clinical Trials with Arbitrary Survival Curves and Group Sequential Testing PATRICIA A. CLEARY, ROY W. BECK, MAI.COLM M. ANDERSON, DAVID J. KENNY, JYE-YU BACKLUND, PETER R. GILBERT, AND THE OPTIC NEURITIS STUDY GROUP Design, Methods, and Conduct of the Optic Neuritis Treatment Trial JOHN L. KELTNER, CHRIS A. JOHNSON, ROY W. BECK, PATRICIA A. CLEARY, JOHN O. SPURR, AND THE OPTIC NEURITIS STUDY GROUP Quality Control Functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT) PMA BIOSTATISTICS AND MEDICAL AD HOC COMMITTEE ON INTERIM ANALYSIS Interim Analysis in the Pharmaceutical Industry: The PMA Position GEORGE L. SPAETH Letter to the Editor Concerning Silverman’s Suspended Judgment Article “The Most Noble Goal of Medicine” Published December 1991 JOHN R. HUGHES Letter to the Editor Exclusion of “Noncompliant” Individuals from Clinical Trials Volume 14, Number 2, 1993 Supplement The Lung Health Study: Design of the Trial and Recruitment of Participants THE LUNG HEALTH STUDY RESEARCH GROUP The Lung Health Study: Introduction JOHN E CONNETT, JOHN W. KUSEK, WILLIAM C. BAILEY, PEGGY O’HARA, AND MARGARET WU FOR THE LUNG HEALTH STUDY RESEARCH GROUP Design of the Lung Health Study: A Randomized Clinical Trial of Early Intervention for Chronic Obstructive Pulmonary Disease DEBORAH A. DURKIN, MARCUS O. KJELSBERG, A. SONIA BUIST, JOHN E. CONNETT, GREGORY R. OWENS, AND RECRUITMENT DIRECTORS OF THE LUNG HEALTH STUDY FOR THE LUNG HEALTH STUDY RESEARCH GROUP Recruitment of Participants in the Lung Health Study, I: ’ Description of Methods JOHN E. CONNETT, WENDY M. BJORNSON-BENSON, AND KATHLEEN DANIELS, FOR THE LUNG HEALTH STUDY RESEARCH GROUP Recruitment of Participants in the Lung Health Study, II: Assessment of Recruiting Strategies WENDY M. BJORNSON-BENSON, THOMAS B. STIBOLT, KENNETH A. MANSKE, KATHLEEN J. ZAVELA, DIANA J. YOUTSEY, AND A. SONIA BUIST Monitoring Recruitment Effectiveness and Cost in a Clinical Trial CATHY RUDICK, NICHOLAS R. ANTHONISEN, AND JURE MANFREDA Recruiting Healthy Participants for a Large Clinical Trial Appendix: Lung Health Study Participants Volume 14, Number 3, 1993 HEINZ W. BERENDES AND YOUNG J. LEE Suspended Judgment The 1953 Clinical Trial of Diethylstilbestrol During Pregnancy: Could It Have Stopped DES Use? THOMAS R. FLEMING AND DAVID L. DEMETS Monitoring of Clinical Trials: Issues and Recommendations JONATHAN J. SHUSTER Fixing the Number of Events in Large Comparative Trials With Low Event Rates: A Binomial Approach JEAN-MAURICE DUMONT Effect of Cholesterol Reduction by Simvastatin on Progression of Coronary Atherosclerosis: Design, Baseline Characteristics, and Progress of the Multicenter Anti-Atheroma Study (MAAS) THE ODES INVESTIGATORS The Oslo Diet and Exercise Study (ODES): Design and Objectives ROBERT P. MCMAHON Letter to the Editor In Response to an Article by Lemuel Moye (CCT 12(6)) Entitled ‘Central Laboratory Sampling Plans and Quality Control in Clinical Trials’ NICHOLAS LANGE Letter to the Editor In Response to an Article by Lemuel Moye (CCT (12(6)) Entitled ‘Central Laboratory Sampling Plans and Quality Control in Clinical Trials’ LEMUEL A. MOYE Letter to the Editor Response to McMahon and Lange THOMAS A. LOUIS Book Review Medical Statistics: A Commonsense Approach by Michael J. Campbell and David Machin MITCHELL H. GAIL AND DONALD K. CORLE Erratum Volume 14, Number 4, 1993 CURTIS L. MEINERT Editorial In Defense of the Corporate Author for Multicenter Trials PHILIP PETTIT Suspended Judgment Instituting a Research Ethic JOHN W. TUKEY Tightening the Clinical Trial EDWARD L. KORN, KAI F. YU, AND LANGDON L. MILLER Stopping a Clinical Trial Very Early Because of Toxicity: Summarizing the Evidence ETTORE MARUBINI, MARIO BRAGA, MARIA LEA CORREA LEITE, ANNA PETROCCIONE, NICOLETTA PIROTTA, ON BEHALF OF SINBA GROUP “Within Patient”—Dependent Outcomes in Graft Occlusion After Coronary Artery Bypass MARK D. THORNQUIST, GILBERT S. OMENN, GARY E. GOODMAN, JAMES E. GRIZZLE, LINDA ROSENSTOCK, SCOTT BARNHART, GARNET L. ANDERSON, SAMUEL HAMMAR, JOHN BALMES, MARTIN CHERNIACK, JAMES CONE, MARK R. CULLEN, ANDREW GLASS, JAMES P. KEOGH, FRANK MEYSKENS, JR., BARBARA VALANIS, AND JAMES H. WILLIAMS, JR. Statistical Design and Monitoring of the Carotene and Retinol Efficacy Trial (CARET) MARK D. THORNQUIST, NICOLE URBAN, ADELINA TSENG, CIM EDELSTEIN, BERNEDINE LUND, AND GILBERT S. OMENN Research Cost Analyses to Aid in Decision Making in the Conduct of a Large Prevention Trial, CARET GEORGE L. SPAETH Letter to the Editor JEAN-PIERRE BOISSEL Response to Letter to the Editor Volume 14, Number 5, 1993 WILLIAM A. SILVERMAN Suspended Judgment From “Tame” to “Forbidden” Death BARRY R. DAVIS, JANET WITTES, SARA PRESSEL, KENNETH G. BERGE, C. MORTON HAWKINS, EDWARD LAKATOS, LEMUEL A. MOYE, AND JEFFREY L. PROBSTFIELD Statistical Considerations in Monitoring the Systolic Hypertension in the Elderly Program (SHEP) THE COLLABORATIVE OCULAR MELANOMA STUDY GROUP Design and Methods of Clinical Trial for a Rare Condition: The Collaborative Ocular Melanoma Study: Report No. 3 Announcement Final Program: Fourteenth Annual Meeting of the Society for Clinical Trials Abstracts: Fourteenth Annual Meeting of the Society. for Clinical Trials Volume 14, Number 6, 1993 TONSE N.K. RAJU, PATRICIA LANGENBERG, AND ASHISH SEN Suspended Judgment Treatment Effect Size in Clinical Trials: An Example from Surfactant Trials WILLIAM F. ROSENBERGER AND JOHN M. LACHIN The Use of Response-Adaptive Designs in Clinical Trials RICHARD D. GELBER, ARON GOLDHIRSCH, AND BERNARD F. COLE FOR THE INTERNATIONAL BREAST CANCER STUDY GROUP Parametric Extrapolation of Survival Estimates with Applications to Quality of Life Evaluation of Treatments HENRY BUCHWALD, LAURIE L. FITCH, JOHN P. MATTS, JAMES W. JOHNSON, BETTY J. HANSEN, MERIDITH R. STUENKEL, AND HELENE B. BROOKS FOR THE POSCH GROUP Perception of Quality of Life Before and After Disclosure of Trial Results: A Report from the Program on the Surgical Control of the Hyperlipidemias (POSCH) BERCEDIS PETERSON AND STEPHEN L. GEORGE Sample Size Requirements and Length of Study for Testing Interaction in a2 x k Factorial Design When Time-to-Failure Is the Outcome LINDA L. ROSENDORF, URANIA DAFNI, DAVID A. AMATO, BARBARA LUNGHOFER, JOHN G. BASRTLETT, JOHN M. LEEDOM, DIANE W. WARA, JOHN A. ARMSTRONG, ELLEN GODFREY, EVIND SUKKESTAD, AND GEORGE W. COUNTS Performance Evaluation in Multicenter Clinical Trials: Development of a Model by the AIDS Clinical Trial Group JOHN W. KUSEK, TERRY COYNE, ANN DE VELASCO, MARTIN J. DRABIK, R. ALLAN FINLAY, JENNIFER J. GASSMAN, SALLY KIEFER, SANDRA N. POWERS, AND THEODORE I. STEINMAN Recruitment Experience in the Full-Scale Phase of the Modification of Diet in Renal Disease Study Petition Regarding the 103rd Congressional Mandate Directive to the Director of the NIH ARGYE HILLIS Letter to the Editor The Role of Clinical Research in Containing Health Care Costs STEVEN PIANTADOSI AND JANET WITTES Letter to the Editor Politically Correct Clinical Trials JOHN McKELLAR Letter to the Editor Note on the Value of 24-Hour Ambulatory Blood Pressure Devices LAWRENCE J. APPEL Letter to the Editor In Response to Letter “Note on the Value of 24-Hour Ambulatory Blood Pressure Devices” Reviewers of Controlled Clinical Trials Volume 14 Author Index Volume 14 Subject Index Volume Contents