Data Monitoring in Clinical Trials

During the past three decades, clinical trials have evolved to become major research methodology for clinical medicine. Many statistical principles have been applied to the design, conduct, and anlysis of clinical trials, and these statistical methodologies continue to evolve as we apply clinical trials to an increasing array of research settings.

Inhalt
Monitoring Committees: Why and HowDavid L. DeMets, Curt D. Furberg, Lawrence M. Friedman .-Lessons LearnedDavid L. DeMets .- FDA PerspectiveSusan S. Ellenberg and Jay P. Siegel.- IntroductionLawrence M. Friedman .- Assessing Possible Late Treatment Effects Early- The Diabetic Retinopathy Study ExperienceFred Ederer .- Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial- Early Experiences in Formal Monitoring MethodsLawrence M. Friedman, David L. DeMets and Robert Hardy .- Data Monitoring for the Aspirin Component of the Physicians Health Study- Importance of Secondary OutcomesDavid L. DeMets and Charles H. Hennekens .- Early Termination of the Stroke Prevention in Atrial Fibrillation I Trial- Protecting Participant Interests in the Face of Scientific Uncertainties and the Cruel Play of ChanceRobert G. Hart, Lesly A. Pearce, Ruth McBride and Richard A. Kronmal .- Early Termination of the Diabetes Control and Complications Trial Methodologic IssuesJohn M Lachin, Patricia Cleary, Oscar Crofford, Saul Genuth, David Nathan, Charles Clark, Frederick Ferris, and Carolyn Sieberg for the DCCT Research Group .- Data Monitoring in the AIDS Clinical Trials Group Study #981- Conflicting Interim ResultsDianne Finkelstein .- Challenges in Monitoring the Breast Cancer Prevention TrialCarol K. Redmond,Joseph P. Costantino andTheodore Colton .- Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure- Potentially High Risk Treatment in High Risk PatientsJan Feyzi, Desmond Julian, John Wikstrand and Hans Wedel .- Stopping the Randomized Aldactone Evaluation Study Early for EfficacyJanet Wittes, Jean-Pierre Boissel, Curt Furberg, Desmond Julian, Henri Kulbertus and Stuart Pocock .- Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events Trials- Avoiding Important Information LossJanice Pogue, David Sackett, George Wyse and SalimYusuf .- Data Monitoring in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity ProgramStuart Pocock, Duolao Wang,Lars Wilhelmsen andCharles Hennekens .- IntroCurt D. Furberg .- Breaking New Ground - Data Monitoring in the Coronary Drug ProjectPaul L. Canner .- Data Monitoring in the Cardiac Arrhythmia Suppression Trial The Need to Be Prepared EarlyDavid L. DeMets and Lawrence M. Friedman .- Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation Trial- Dealing with an Agonizing TrendSusan Anderson, Robert Cody, Milton Packer andRichard Schwarz .- Stopping the Carotene and Retinol Efficacy Trial - The Viewpoint of the Safety and Endpoint Monitoring CommitteeAnthony B. Miller, Julie Buring and O. Dale Williams .- Monitoring a Clinical Trial with Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post - Traumatic ShockRoger L. Lewis and Norman Fost .- Challenges in Monitoring the Heart and Estrogen/progestin Replacement StudyStephen B. Hulley,Deborah Grady, Eric Vittinghoff and O. Dale Williams .- Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial- Early Termination of the Doxazosin ArmBarry R. Davis and Jeffrey A. Cutler .- Data Monitoring in the Moxonidone Congestive Heart Failure TrialStuart Pocock, Lars Wilhelmsen, Kenneth Dickstein, Gary Francis and Janet Wittes .- Data Monitoring of a Placebo-controlled Trial of Daclizumab in Acute Graft-versus-Host DiseaseDavid Zahrich, Stephanie J. Lee and David Harrington .- IntroductionDavid L. DeMets .- Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring CommitteeRichard J. Whitley .- The Nocturnal Oxygen Therapy Trial Data Monitoring Experience Problem with Reporting LagsDavid L. DeMets, George W. Williams andByron W. Brown, Jr. .- The Cooperative North Scandinavian Enalapril Survival Study II TrialSteven