Table Of Content

Controlled Clinical Trials DESIGN, METHODS, AND ANALYSIS Official Journal of the Society for Clinical Trials Volume 24, Number 1, 2003 Contents Call for papers Preface Original articles MICHAEL A. PROSCHAN, QING LIU, SALLY HUNSBERGER Practical midcourse sample size modification in clinical trials Y.H. JOSHUA CHEN, DAVID L. DEMETS, K.K. GORDON LAN Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis NEAL L. ODEN, DALE L. PHELPS, ON BEHALF OF THE STOP-ROP MULTICENTER STUDY GROUP Statistical issues related to early closure of STOP-ROP, a group-sequential trial DEBORAH J. BOWEN, MARK THORNQUIST, KAREN ANDERSON, MATT BARNETT, CORINNE POWELL, GARY GOODMAN, GILBERT OMENN Stopping the active intervention: CARET LETICIA DELGADO-HERRERA, DAN ANBAR A model for the interim analysis process: a case study Invited papers KEITH WHEATLEY, DAVID CLAYTON Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization JOSEPH F. COLLINS Data and safety monitoring board issues raised in the VA Status Epilepticus Study MARIO CHEN-MOK, SHRIKANT I. BANGDIWALA, ROSALIE DOMINIK, MELISSA HAYS, BELINDA IRSULA, DAVID C. SOKAL Termination of a randomized controlled trial of two vasectomy techniques DAVID W. HILLMAN, THOMAS A. LOUIS DSMB case study: decision making when a similar clinical trial is stopped early ADELE M. KAPLAN GILPIN, JANET T. HOLBROOK, DOUGLAS A. JABS, CURTIS L. MEINERT, FOR THE STUDIES OF OCULAR COMPLICATIONS OF AIDS RESEARCH GROUP Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial DAVID SCHEIFELE, BERNARD DUVAL, GASTON DE SERRES, DANUTA M. SKOWRONSKI Unique roles of a data and safety monitoring board in vaccine safety trials with compressed timelines and urgent implications Book review List of reviewers Volume 24, Number 2, 2003 Contents Call for papers Original articles SAY-BENG TAN, Y.-F. ALEXANDER CHUNG, BEE-CHOO TAI, YIN-BUN CHEUNG, DAVID MACHIN Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma A. GREGORY DIRIENZO, VICTOR DEGRUTTOLA Design and analysis of clinical trials with a bivariate failure time endpoint, with application to AIDS Clincial Trials Group Study A5142 HONGYU JIANG, RICK CHAPPELL, JASON P. FINE Estimating the distribution of nonterminal event time in the presence of mortality or informative dropout SUE-JANE WANG, H.M. JAMES HUNG Assessing treatment efficacy in noninferiority trials VANCE W. BERGER, AZADEH REZVANI, VANESSA A. MAKAREWICZ Direct effect on validity of response run-in selection in clinical trails JITENDRA GANJU, DEVAN V. MEHROTRA Stratified experiments reexamined with emphasis on multicenter trials ARTHUR A. STONE, SAUL SHIFFMAN, JOSEPH E. SCHWARTZ, JOAN E. BRODERICK, MICHAEL R. HUFFORD Patient compliance with paper and electronic diaries Book reviews Design papers WENDY DEMARK-WAHNEFRIED, MIRIAM C. MOREY, ELIZABETH C. CLIPP, CARL F. PIEPER, DENISE CLUTTER SNYDER, RICHARD SLOANE, HARVEY J. COHEN Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors OLIVER M. BAUTISTA, JOHN W. KUSEK, LEROY M. NYBERG JR., JOHN D. MCCONNELL, RAYMOND P. BAIN, GARY MILLER, E. DAVID CRAWFORD, STEVEN A. KAPLAN, STEPHEN A. SIHELNIK, MICHAEL K. BRAWER, HEBERT LEPOR, FOR THE MTOPS RESEARCH GROUP Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial Volume 24, Number 3, 2003 Contents Original articles WILLIAM BURMAN, PETER BREESE, STEPHEN WEIS, NAOMI BOCK, JOHN BERNARDO, ANDREW VERNON, AND THE TUBERCULOSIS TRIALS CONSORTIUM The effects of local review on informed consent documents from a multicenter clinical trials consortium ROBERT M. CALIFF, MICHAEL A. MORSE, JANET WITTES, STEVEN N. GOODMAN, DANIEL K. NELSON, DAVID L. DEMETS, R. PETER LAFRATE, JEREMY SUGARMAN Toward protecting the safety of participants in clinical trials NICOLA MILLS, JENNY L. DONOVAN, MONICA SMITH, ANN JACOBY, DAVID E. NEAL, FREDDIE C. HAMDY Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study CHENGJIE XIONG, YAN YAN, MING JI Sample sizes for comparing means of two lifetime distributions with type II censored data: application in an aging intervention study STEVEN E. FELDON, ROBERTA W. SCHERER, FRANK J. HOOPER, SHALOM KELMAN, ROBERT S. BAKER, ROBERT J. GRANADIER, GREGORY S. KOSMORSKY, STUART R. SEIFF, KAY DICKERSIN, FOR THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL RESEARCH GROUP Surgical quality assurance in the Ischemic Optic Neuropathy Decompression Trial (ONDT) DAVID JARJOURA Crossing controls to treatment in repeated-measures trials CHRISTOPHER H. SCHMID, MARCIA LANDA, TAZEEN H. JAFAR, IOANNIS GIATRAS, TAUQEER KARIM, MANOJ REDDY, PAUL C. STARK, ANDREW S. LEVEY, FOR THE ANGIOTENSIN-CONVERTING ENZYME INHIBITION IN PROGRESSIVE RENAL DISEASE (AIPRD) STUDY GROUP Constructing a database of individual clinical trials for longitudinal analysis AL HALLSTROM, LAWRENCE FRIEDMAN, PABLO DENES, CARLOS RIZO-PATRON, MARY MORRIS, AND THE CAST AND AVID INVESTIGATORS Do arrhythmia patients improve survival by participating in randomized clinical trials? Observations from the Cardiac Arrhythmia Suppression Trial (CAST) and the Antiarrhythmics Versus Implantable Defibrillators Trial (AVID) Book review Volume 24, Number 3S, 2003 Supplement Contents Letter from the President Calendar of Program Abstracts: Third Joint Meeting of the Society for Clinical Trials and the International Society for Clinical Biostatistics Author Index Volume 24, Number 4, 2003 Contents Original articles MITHAT GONEN Planning for subgroup analysis: a case study of treatment-marker interaction in metastatic colorectal cancer MAN-LAI TANG Matched-pair noninferiority trials using rate ratio: a comparison of current methods and sample size refinement JAMES X. SONG, JAMES T. WASSELL Sample size for K 2 x 2 tables in equivalence studies using Cochran’s statistic REBECCA HOLMAN, CEES A.W. GLAS, ROB J. DE HAAN Power analysis in randomized clinical trials based on item response theory LAURENCE S. MAGDER Simple approaches to assess the possible impact of missing outcome information on estimates of risk ratios, odds ratios, and risk differences MARIE JACKSON, NANCY BERMAN, MARGARET HUBER, LINDA SNETSELAAR, IRIS GRANEK, KATHRYN BOE, CAROLE MILAS, JILL SPIVAK, ROWAN T. CHLEBOWSKI Research staff turnover and participant adherence in the Women’s Health Initiative Letter to the editor Book review Design papers THE BENEDICT GROUP The BErgamo NEphrologic Dlabetes Complications Trial (BENEDICT): design and baseline characteristics GARY D. MILLER, W. JACK REJESKI, JEFF D. WILLIAMSON, TIMOTHY MORGAN, MARY ANN SEVICK, RICHARD F. LOESER, WALT H. ETTINGER, STEPHEN P. MESSIER FOR THE ADAPT INVESTIGATORS The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results PASSOS C. KYRIAKIDES, ABDEL BABIKER, JOEL SINGER, WILLIAM CAMERON, MARTIN T. SCHECHTER, MARK HOLODNIY, SHELDON T. BROWN, MIKE YOULE, BRIAN GAZZARD ON BEHALF OF THE OPTIMA STUDY TEAM An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial Volume 24, Number 5, 2003 Contents Original articles RAYMOND Q. MIGRINO, ERIC J. TOPOL A matter of life and death? The Heart Protection Study and protection of clinical trial participants THEODORE G. KARRISON, DEZHENG HUO, RICK CHAPPELL A group sequential, response-adaptive design for randomized clinical trials CAROLINE C. MORGAN Estimation following group-sequential response-adaptive clinical trials LUKE B. CONNELLY Balancing the number and size of sites: an economic approach to the optimal design of cluster samples MIYUKI KAWADO, SHIRO HINOTSU, YUTAKA MATSUYAMA, TAKUHIRO YAMAGUCHI, SHUJI HASHIMOTO, YASUO OHASHI A comparison of error detection rates between the reading aloud method and the double data entry method MIKE R. SATHER, DENNIS W. RAISCH, CLAIR M. HAAKENSON, JULIA M. BUCKELEW, JOHN R. FEUSSNER Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program Commentary SUSAN S. ELLENBERG Are all monitoring boundaries equally ethical? Book review Design papers KAY DICKERSIN, MALCOLM MUNRO, PATRICIA LANGENBERG, ROBERTA SCHERER, KEVIN D. FRICK, ANNE M. WEBER, ALAN JOHNS, JEFFREY F. PEIPERT, MELISSA CLARK, AND THE STOP-DUB RESEARCH GROUP Surgical Treatrnents Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB): design and methods THE LOOK AHEAD RESEARCH GROUP Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes LINDA BRUBAKER, GEOFF CUNDIFF, PAUL FINE, INGRID NYGAARD, HOLLY RICHTER, ANTHONY VISCO, HALINA ZYCZYNSKI, MORTON B. BROWN, ANNE WEBER, FOR THE PELVIC FLOOR DISORDERS NETWORK A randomized trial of colpopexy and urinary reduction efforts (CARE): design and methods J.M. STEPHENSON, A. OAKLEY, A.M. JOHNSON, S. FORREST, V. STRANGE, S. CHARLESTON, S. BLACK, A. COPAS, A. PETRUCKEVITCH, A. BABIKER A school-based randomized controlled trial of peer-led sex education in England Announcements Program 2003 Errata Volume 24, Number 6, 2003 Contents Preface Original articles THOMAS M. BRAUN, JOHN E. LEVINE, JAMES L.M. FERRARA Determining a maximum tolerated cumulative dose: dose reassignment within the TITE-CRM KEVIN J. CARROLL On the use and utility of the Weibull model in the analysis of survival data PHILIP P. BREITFELD, FRED ULLRICH, JAMES ANDERSON, WILLIAM M. CRIST Web-based decision support for clinical trial eligibility determination in an international clinical trials network JEFFREY J. WALLINE, LISA A. JONES, DONALD O. MUTTI, KARLA ZADNIK Use of a run-in period to decrease loss to follow-up in the Contact Lens and Myopia Progression (CLAMP) study Invited papers SHEILA SPRAGUE, PAMELA LEECE, MOHIT BHANDARI, PAUL TORNETTA, EMIL SCHEMITSCH, MARC F. SWINOTKOWSKI, ON BEHALF OF THE S.P.R.I.N.T. INVESTIGATORS Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery JOSEPH F. COLLINS, CINDY L. HOWELL, R. ANNE HORNEY FOR THE DIGITALIS INVESTIGATION GROUP (DIG) INVESTIGATORS Determination of vital status at the end of the DIG trial ANDREW J. VICKERS, ROB MCCARNEY Use of a single global assessment to reduce missing data in a clinical trial with follow-up at one year Design papers CHRISTIAN C. APFEL, KARI KORTTILA, MONA ABDALLA, ANDREAS BIEDLER, PETER KRANKE, STUART J. POCOCK, N. ROEWER An International Multicenter Protocol to Assess the single and combined benefits of antiemetic interventions in a Controlled clinical Trial of a 2* 2x22 Xx 2 X 2 factorial design (IMPACT) MICHIEL L. BOTS, GREGORY W. EVANS, WARD RILEY, RUDY MEIJER, KAREN H. MCBRIDE, ELECTRA D. PASKETT, FRANS A. HELMOND, DIEDERICK E. GROBBEE, FOR THE OPAL INVESTIGATORS [he Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study: design and baseline characteristics ROB BEANLANDS, GRAHAM NICHOL, TERRENCE D. RUDDY, ROBERT A. DEKEMP, PAUL HENDRY, DENNIS HUMEN, NORMAND RACINE, HEATHER ROSS, FRANCOIS BENARD, GEOFFREY COATES, ROBERT M. IWANOCHKO, ERNEST FALLEN, GEORGE WELLS, AND THE PARR-2 INVESTIGATORS Evaluation of outcome and cost-effectiveness using an FDG PET-guided approach to management of patients with coronary disease and severe left ventricular dysfunction (PARR-2): rationale, design, and methods THE CHILDREN’S AMALGAM TRIAL STUDY GROUP The Children’s Amalgam Trial: design and methods THE CTNS STUDY GROUP lhe Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract (CTNS): design implications. CTNS report no. 1 List of Reviewers Volume 24 Author Index Volume 24 Subject Index Volume Contents Volume 24, Number 6S, 2003 Supplement Contents List of contributors JOSEPH F. COLLINS, DEBRA EGAN, SALIM YUSUF, REKHA GARG, WILLIAM O. WILLIFORD, NANCY GELLER ON BEHALF OF THE DIG INVESTIGATORS Overview of the DIG trial WILLIAM O. WILLIFORD, JOSEPH F. COLLINS, ANNE HORNEY, GAIL KIRK, FRANCES MCSHERRY, ELIZABETH SPENCE, SUSAN STINNETT, CINDY L. HOWELL, REKHA GARG, DEBRA EGAN, SALIM YUSUF ON BEHALF OF THE DIG INVESTIGATORS The role of the data coordinating center in the DIG trial CAROL L. FYE, WILLIAM H. GAGNE, DENNIS W. RAISCH, MARK S. JONES, MIKE R. SATHER, SANDRA L. BUCHANAN, FRANCES R. CHACON, REKHA GARG, SALIM YUSUF, WILLIAM O. WILLIFORD ON BEHALF OF THE DIG INVESTIGATORS The role of the pharmacy coordinating center in the DIG trial 290S JOSEPH F. COLLINS, SYLVIA MARTIN, ELEANOR KENT, CONNIE LIUNI, REKHA GARG, DEBRA EGAN ON BEHALF OF THE DIG INVESTIGATORS The use of regional coordinating centers in large clinical trials: the DIG trial 2998 JOSEPH F. COLLINS, REKHA GARG, KOON K. TEO, WILLIAM O. WILLIFORD, CINDY L. HOWELL ON BEHALF OF THE DIG INVESTIGATORS The role of the data coordinating center in the IRB review and approval process: the DIG trial experience DEBRA EGAN, NANCY GELLER, SALIM YUSUF, REKHA GARG, JOSEPH F. COLLINS, JAMES MATHEW, EDWARD PHILBIN ON BEHALF OF THE DIG INVESTIGATORS Lessons learned from the DIG trial Appendix