PPT-A practical trial design for optimising treatment duration

Matteo Quartagno International Clinical Trials Day 14 th May 2018 Acknowledgements This is joint work with Sarah Walker James Carpenter Patrick Phillips and Max Parmar MRC Clinical Trials Unit at UCL. Optimising the productivity of lifting appliances Anti-Sway: controlling the swaying of the load January 2010 / White paper by Jacques Piriou Introduction Optimising production methods Classificatio MBBS (Hons), . MMedSci. (. Clin. . Epid. ), . MBiostat. , PhD, FRACP. Biomarker-Based Clinical Trials: Practical and Design Considerations. Biomarker. “Any characteristic that can be objectively measured as an indicator of normal or pathological biological processes or the response to a therapy”. Optimising the productivity of lifting appliances Anti-Sway: controlling the swaying of the load January 2010 / White paper by Jacques Piriou Introduction Optimising production methods Classificatio Reading: Applied Hydrology Sections 14-1 to 14-4. 2. Hydrologic design . Water control. Peak flows, erosion, pollution, etc. . Water management. Domestic and industrial use, irrigation, instream flows, etc. A RANDOMIZED CONTROLLED. CLINICAL TRIAL. REPRODUCIBILITY IN RESEARCH. “Growing alarm about results that cannot be reproduced” . . Nature Supplement, Challenges in Irreproducible Research, October 7, 2015. ICH Topic E 10 Choice of Control Group in Clinical Trials NOTE FOR GUIDANCE ON CHOICE OF CONTROL GROUP IN CLINICAL TRIALS TRANSMISSION TO CPMP June 1999 LTATION June 1999 DEADLINE FOR COMMENTS Decem ICH Topic E 9 Statistical Principles for Clinical Trials Step 5 NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS (CPMP/ICH/363/96) TRANSMISSION TO CPMP February 1997 RELEASE FOR CONS Non-randomised controlled trial. Randomised controlled trial . Parallel group. Cross-over. Single or double blind. Superiority or non-inferiority trial. 2. Trial design types. In a clinical trial design, there are a number of different types of comparisons that can be included:. 2. Homework 8:. Completely on ED. Will be posted tonight. Partners allowed.. It will be about half as long as a typical HW.. Project:. Website (45 points) and notebook (30 points) due on Wed, 12/11. Outline. Review of a phase I trial. What is a phase II trial?. Phase II trial process. Standard trial designs. Innovative trial designs. Phase II trial examples. Guess that trial. Phase II thalidomide study. D. esigns. 2. Steps in clinical . d. evelopment . p. rograms. Phase I:. . Studies on . dosing. Phase . III:. . Assess . therapeutic effect and benefit-risk in patients of candidate vs. standard of . MAMS. ) randomised controlled trials with binary outcomes. Babak Choodari-Oskooei. Daniel Bratton, Mahesh KB Parmar. 7-8 September 2023. MRC Clinical Trials Unit at UCL. Institute of Clinical Trials & Methodology, University College London. John Scott, Ph.D.. Director, Division of Biostatistics. Office of Biostatistics and Epidemiology. Center for Biologics Evaluation and Research. FDA. Disclaimer. This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. B. rain . I. njury . T. reatment Trial: A Multicenter Phase II Adaptive Clinical Trial. . Gaylan. . Rockswold. , MD, PhD, Principal Investigator. Thomas Bergman, MD, Site Principal Investigator. Overview.