Table Of Content

Controlled Clinical Trials DESIGN, METHODS, AND ANALYSIS Official Journal oft he Society for Clinical Trials Volume 20, Number 1, 1999 LLOYD D. FISHER AND LEMUEL A. MOYE Carvedilol and the Food and Drug Administration Approval Process: An Introduction LLOYD D. FISHER Carvedilol and the Food and Drug Administration (FDA) Approval Process: The FDA Paradigm and Reflections on Hypothesis Testing LEMUEL A. MOYE End-Point Interpretation in Clinical Trials: The Case for Discipline LLOYD D. FISHER Carvedilol and the Food and Drug Administration-Approval Process: A Brief Response to Professor Moyé’s Article BRUCE THOMPSON, NANCY L. GELLER, SALLY HUNSBERGER, MARGARET FREDERICK, ROBIN HILL, ROLF G. JACOB, EDWIN A. SMITH, PETER KAUFMANN, ROBERT R. FREEDMAN, FREDERICK M. WIGLEY, AND LEONARD BIELORY Behavioral and Pharmacologic Interventions: The Raynaud’s Treatment Study Book Reviews Software Review Design Papers WAFAIE W. FAWZI, GERNARD I. MSAMANGA, DONNA SPIEGELMAN, ERNEST J. N. URASSA, AND DAVID J. HUNTER Rationale and Design of the Tanzania Vitamin and HIV Infection Trial CHILDHOOD ASTHMA MANAGEMENT PROGRAM RESEARCH GROUP The Childhood Asthma Management Program (CAMP): Design, Rationale, and Methods Volume 20, Number 2, 1999 JANET WITTES, EDWARD LAKATOS, DENNIS BLACK, BARBARA GERACI, BARRY DAVIS, LEMUEL MOYE, AND JEFFREY PROBSTFIELD Selecting Screening Criteria for Clinical Trials: An Example from the Systolic Hypertension in the Elderly Program NORA COSGROVE, NEMAT O. BORHANI, GERI BAILEY, PATTY BORHANI, JULIE LEVIN, MARY HOFFMEIER, SUSAN KRIEGER, LAURA C. LOVATO, HELEN PETROVITCH, THOMAS VOGT, ALAN C. WILSON, VINCENT BREESON, JEFFREY L. PROBSTFIELD, FOR THE SYSTOLIC HYPERTENSION IN THE ELDERLY PROGRAM (SHEP) COOPERATIVE RESEARCH GROUP Mass Mailing and Staff Experience in a Total Recruitment Program for a Clinical Trial: The SHEP Experience CLAIRE SNOWDON, DIANA ELBOURNE, AND JO GARCIA Zelen Randomization: Attitudes of Parents Participating in a Neonatal Clinical Trial 149 CHRISTOPHER R. PALMER AND WILLIAM F. ROSENBERGER Ethics and Practice: Alternative Designs for Phase III Randomized Clinical Trials 172 PHILIP W. LAVORI, JEREMY SUGARMAN, MARGUERITE T. HAYS, AND JOHN R. FEUSSNER Improving Informed Consent in Clinical Trials: A Duty to Experiment 187 EUGENIO SANTORO, ENRICO NICOLIS, MARIA GRAZIA FRANZOSI, AND GIANNI TOGNONI Internet for Clinical Trials: Past, Present, and Future 194 Software Review 202 List of Reviewers 205 Volume 20, Number 3, 1999 PETER ARMITAGE ON BEHALF OF THE CONCORDE AND ALPHA DATA AND SAFETY MONITORING COMMITTEE Data and Safety Monitoring in the Concorde and Alpha Trials 207 PETER ARMITAGE ON BEHALF OF THE DELTA DATA AND SAFETY MONITORING COMMITTEE Data and Safety Monitoring in the Delta Trial 229 DANIEL J. SARGENT, JEFF A. SLOAN, AND STEVEN S. CHA Sample Size and Design Considerations for Phase II Clinical Trials with Correlated Observations 242 JOHN P.A. IOANNIDIS, DENNIS O. DIXON, MARTIN MCINTOSH, JEFFREY M. ALBERT, SAMUEL A. BOZZETTE, AND STEVEN A. SCHNITTMAN Relationship Between Event Rates and Treatment Effects in Clinical Site Differences Within Multicenter Trials: An Example from Primary Pneumocystis carinii Prophylaxis 253 PAULA DIEHR, DONALD L. PATRICK, GREGORY L. BURKE, AND JEFF WILLIAMSON Survival Versus Years of Healthy Life: Which Is More Powerful as a Study Outcome? 267 PHYLLIS A. GIMOTTY, ROBERT C. BURACK, AND JULIE GEORGE A Randomized Design for Repeated Binary Outcomes Used to Evaluate Continued Effectiveness of a Breast Cancer Control Intervention Strategy 280 Book Review Design Paper EDWARD O. MCFALLS, HERBERT B. WARD, WILLIAM C. KRUPSKI, STEVEN GOLDMAN, FRED LITTOOY, KIM EAGLE, JOHN A. NYMAN, THOMAS MORITZ, STACY MCNABB, AND WILLIAM G. HENDERSON FOR THE VETERANS AFFAIRS COOPERATIVE STUDY GROUP ON CORONARY ARTERY REVASCULARIZATION PROPHYLAXIS FOR ELECTIVE VASCULAR SURGERY Prophylactic Coronary Artery Revascularization for Elective Vascular Surgery: Study Design 297 Volume 20, Number 4, 1999 DANIEL F. HEITJAN Causal Inference in a Clinical Trial: A Comparative Example VANCE W. BERGER AND DEREK V. EXNER Detecting Selection Bias in Randomized Clinical Trials WILLIAM F. ROSENBERGER Randomized Play-the-Winner Clinical Trials: Review and Recommendations P.Y. LIU, MICHAEL LEBLANC, AND MANISHA DESAI False Positive Rates of Randomized Phase II Designs MYRON N. CHANG, JONATHAN J. SHUSTER, AND JAMES L. KEPNER Group Sequential Designs for Phase II Trials With Historical Controls Book Review Letter to the Editor Design Papers ROBERT G. HOLLOWAY, DAVID R. GIFFORD, MARTIN R. FRANKEL, AND BARBARA G. VICKREY A Randomized Trial to Implement Practice Recommendations: Design and Methods of the Dementia Care Study BEPPIE S.P. HELLEMONS, MACHTELD LANGENBERG, JAN LODDER, FRANK VERMEER, HUBERT J.A. SCHOUTEN, THEY G.J. LEMMENS, JAN W. vAN REE, AND J. ANDRE KNOTTNERUS Primary Prevention of Arterial Thromboembolism in Nonrheumatic Atrial Fibrillation: The PATAF Trial Study Design Volume 20, Number 5, 1999 BORIS FREIDLIN, EDWARD L. KORN, AND STEPHEN L. GEORGE Data Monitoring Committees and Interim Monitoring Guidelines JOHN M. LACHIN Worst-Rank Score Analysis with Informatively Missing Observations in Clinical Trials MINGGAO GU AND TZE°LEUNG LAI Determination of Power and Sample Size in the Design of Clinical Trials with Failure-Time Endpoints and Interim Analyses EMMANUEL LESAFFRE AND GORDON PLEDGER A Note on the Number Needed to Treat HEATHER D. CLARK, GEORGE A. WELLS, CHARLOTTE HUET, FINLAY A. MCALISTER, L. RACHID SALMI, DEAN FERGUSSON, AND ANDREAS LAUPACIS Assessing the Quality of Randomized Trials: Reliability of the Jadad Scale DAVID SALSBURG Why Analysis of Variance Is Inappropriate for Multiclinic Trials Commentary WEICHUNG JOE SHIH Comment on “Why Analysis of Variance is Inappropriate for Multiclinic Trials” by David Salsburg Book Reviews Letter to the Editor Design Papers NICK FREEMANTLE, MARTIN ECCLES, JOHN WOOD, JAMES MASON, IRWIN NAZARETH, CATHERINE DUGGAN, PHILIP YOUNG, ANDREW HAINES, MIKE DRUMMOND, IAN RUSSELL, AND TOM WALLEY A Randomized Trial of Evidence-Based Outreach (EBOR): Rationale and Design BARRY I. FREEDMAN, JEAN-PAUL WUERTH, KENNETH CARTWRIGHT, RAYMOND P. BAIN, STEPHEN DIPPE, KENNETH HERSHON, ARSHAG D. MOORADIAN, AND BRUCE S. SPINOWITZ FOR THE ACTION II STUDY INVESTIGATORS Design and Baseline Characteristics for the Aminoguanidine Clinical Trial in Overt Type 2 Diabetic Nephropathy (ACTION II) Volume 20, Number 6, 1999 JOSEF HOGEL AND WILHELM GAUS The Procedure of New Drug Application and the Philosophy of Critical Rationalism or The Limits of Quality Assurance with Good Clinical Practice GERHARD SVOLBA AND PETER BAUER Statistical Quality Control in Clinical Trials KRISTA FISCHER-LAPP AND ELS GOETGHEBEUR Practical Properties of Some Structural Mean Analyses of the Effect of Compliance in Randomized Trials RORY WOLFE AND JOHN B. CARLIN Sample-Size Calculation for a Log-Transformed Outcome Measure JOHN J. HANFELT, REBECCA S. SLACK AND EDMUND A. GEHAN A Modification of Simon’s Optimal Design for Phase II Trials When the Criterion Is Median Sample Size Commentary JANET DARBYSHIRE Confirmatory Trials—A New Approach? Letters to the Editor Design Papers THE AGE-RELATED EYE DISEASE STUDY RESEARCH GROUP The Age-Related Eye Disease Study (AREDS): Design Implications AREDS Report No. 1 DOUGLASS A. MORRISON, GULSHAN SETHI, JEROME SACKS, FREDERICK GROVER, STEVEN SEDLIS, RICK ESPOSITO, K.B. RAMANATHAN, DARRYL WEIMAN, MITCHELL KRUCOFF, FRANCIS DUHAYLONGSOD, THOMAS RAYA, STUART PETT, SARAH VERNON, VALDIMIR BIRJINIUK, DAVID BOOTH, CLIVE ROBINSON, J. DAVID TALLEY, TAMIM ANTCKLI, EDWARD MURPHY, HARKNESS FLOTEN, VLADIMIR CURCOVIC, JOHN C. LUCKE, DAN LEWIS, CHARLES BARBIERE, AND WILLIAM HENDERSON FOR THE AWESOME (VETERANS AFFAIRS COOPERATIVE STUDY #385, ANGINA WITH EXTREMELY SERIOUS OPERATIVE MORTALITY EVALUATION) INVESTIGATORS FROM THE COOPERATIVE STUDIES PROGRAM OF THE DEPARTMENT OF VETERANS AFFAIRS A Multicenter, Randomized Trial of Percutaneous Coronary Intervention Versus Bypass Surgery in High-Risk Unstable Angina Patients Author Index Subject Index Volume Contents