PPT-Adaptive Trial Designs

Global Forum on Bioethics in Research Emerging Epidemic Infections and Experimental Treatments November 4 2015 Lord Kelvin I often say that when you can measure what you are speaking about and express it in numbers you know something about it but when you cannot measure it when you cannot express it in numbers your knowledge is of a meagre and unsatisfactory kind it may be the beginning of knowledge but you have scarcely in your thoughts advanced to the state of Science whatever the matter may be. Andy Grieve. SVP Clinical Trials Methodology, . Innovation Centre, Aptiv Solutions.. 1. Outline. Basic Principles of Adaptive . Designs. Why . adaptive trials?. Differences Between Early / Late Phase Adaptive Designs. When is it appropriate to combine phasesVlad DragalinStatistical Research and Applications Global Biostatistics & Programming V. Dragalin | EMEA-EFPIA Workshop on Adaptive Designs | Dec 14, 2007 | Lon in Cardiovascular Outcome Trials. A Case Study of the EXAMINE Trial. Cyrus Mehta Ph.D. and Lingyun Liu Ph.D. Cytel Inc., Cambridge MA. Multicenter randomized double blind placebo controlled study of Alogliptin a DPP4 inhibitor. Acknowledgements to collaborators:. Steven . Julious. , Susan Todd, Jon Nicholl, and Jonathan . Boote. #ICTMC2015. Meandering journey towards routine trial adaptation: survey results on barriers to use of adaptive designs in confirmatory trials. Acknowledgements to collaborators:. Stevely. A, Todd S, . Julious. S, Nicholl J, Hind D, and Cooper C. . #ICTMC2015. 1. Investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials. Colorado School of Public Health. January 30. th. , 2013. Table of Contents. Orientation. Introduction. Components of a Phase I Trial. Phase I Trial Designs. Rule-Based Designs. Statistical Designs. References. Mahesh Parmar. MRC . Clinical Trials Unit at . UCL. Rationale . for adaptive trials. Our . adaptive trials and their setting. Discuss some broad practical and statistical challenges. Offer some solutions and thoughts. Part 2. Resident and Fellows Lecture Series. A. pril 12, 2016. Elizabeth Garrett-Mayer, . PhD. Hollings Cancer . Center. . Current State of Phase II. Lots of changes in the past several years. Phase I . 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:. 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 . Munya Dimairo. Research Fellow in Medical Statistics. University of Sheffield, UK. m.dimairo@sheffield.ac.uk. . / . mdimairo@gmail.com. . Twitter: @. mdimairo. CREDO Ethiopia 12-13 July 2017. Declarations. What you should know about study design. Demonstrated on . Head of Statistics. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. AGENDA. Adaptive Designs in Confirmatory Trials. Comparing Multiple Treatments for Ebola Virus . Disease: . A Discussion of Ethical Ramifications. Scott Berry. 28 Nov 2017. 1. 2. Classical Trial. Disease. Control. 3. Treatment. Platform Trial (perpetual). 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.