Issues in Selection of Deltas in Non-Inferiority Trials : Acute Bacterial Meningitis and Hospital-Acquired Pneumonia. John H. Powers, M.D. Medical Officer Division of Special Pathogen and Immunologic Drug Products Center for Drug Evaluation and Research U.S. Food and Drug Administration.By lea
Methodologic Challenges: Appraisal of Evidence. Ralph M. Meyer NCIC Clinical Trials Group and Queen’s University. Appraisal of Clinical Trials. 101: Some Basics 202: Strategic Principles of Trial Design 303: The Interim Analysis 404: Biomarkers Beyond: Some issues of drug development.By suzuki
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SILVIO GARATTINI. NON-INFERIORITY TRIALS. Perugia 20 Novembre 2009. THIS PRESENTATION STEMS FROM THE POINT OF VIEW OF PATIENTS AS WELL AS OF THE NATIONAL HEALTH SERVICE. METHODOLOGICAL REQUIREMENTS FOR CLINICAL TRIALS. Ask important questions… …answer them reliably
Non-inferiority trials and switch from non-inferiority to superiority. D Costagliola U 943 INSERM and UPMC Paris 06. References. ICH E 9 et E10
Non-inferiority Trials – Hypotheses and Analyses. Gang Chen 1 , Yongcheng Wang 2 , George Chi 1 , Kevin Liu 1 1 Clinical Biostatistics, Global Drug Development, J&J PRD, 2 Food and Drug Administration November 1, 2004, BASS XI, Savannah, Georgia. Outline.
Statistical & Design Considerations for Non-inferiority trials. Andrew Nunn MRC Clinical Trials Unit London. Outline. What is a non-inferiority trial? How do they differ from superiority trials? What do the regulators say? How large do the trials need to be?
ISSUES THAT PLAGUE NON-INFERIORITY TRIALS PAST AND FUTURE RALPH B. D’AGOSTINO, SR. BOSTON UNIVERSITY HARVARD CLINICAL RESEARCH INSTITUTE OBJECTIVES REVIEW ISSUES: PAST, PRESENT AND FUTURE IN NON-INFERIORITY (NI) STUDIES PRESENT/ DISCUSS EXAMPLES MAKE SOME COMMENTS FOR IMPROVEMENTS
Equivalence, Similarity, and Non-inferiority Clinical Trials in Neurotherapeutics ASENT 10 th Annual Meeting March 2008 Marc K. Walton, M.D., Ph.D. Senior Medical Policy Advisor Office of Policy Office of the Commissioner, FDA.
FDA Anti-Infective Drugs Advisory Committee. Design Issues in ABS Trials: Surrogates Endpoints & Non-Inferiority Trials October 29, 2003 Thomas R. Fleming, Ph.D. Professor and Chair of Biostatistics University of Washington. Design Issues in ABS Trials. Criteria for Study Endpoints
An inferiority complex is defined as an unrealistic feeling of generalized inadequacy caused by actual and supposed inferiority in one sphere, sometimes marked by aggressive behavior for compensation.
Non Inferiority Trial. event rate. 0%. 100%. superiority study. control - placebo. experiment - drug . experiment better. experiment worse. -∞. +∞. 0. ARR=EER-CER. CER. EER. 0%. 100%. event rate. superiority study. control - placebo. experiment - drug .
Power and Non-Inferiority. Richard L. Amdur, Ph.D. Chief, Biostatistics & Data Management Core, DC VAMC Assistant Professor, Depts. of Psychiatry & Surgery Georgetown University Medical Center. Power and Non-Inferiority in Clinical Trials. Richard L. Amdur, Ph.D.