PPT-Balancing the practical implications of adaptive designs with the statistical benefits

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. -Chung Chow. Duke University. USA . 1. Dr. Shein-Chung Chow Biography . Shein-Chung Chow, PhD. is a Professor of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. Prior to joining Duke University, he was Executive Director of National Clinical Trial Network Coordination Center of Taiwan. Prior to that, Dr. Chow held various management positions in the pharmaceutical industry. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association in 1995. He was the recipient of the DIA Outstanding Service Award (1996), and ICSA Extraordinary Achievement Award (1996). Dr. Chow is the author or co-author of over 200 methodology papers and 20 books, which include Design and Analysis of Bioavailability and Bioequivalence Studies, Design and Analysis of Clinical Trials, Sample Size Calculations in Clinical Research, and Adaptive Design Methods in Clinical Trials. 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. Mayank. Jainy. 1, Jung Il Choiy1, Tae Min Kim1, . Dinesh. Bharadia1, . Siddharth. Seth1,. Kannan Srinivasan. 2, . Philip Levis. 1, . Sachin Katti. 1, . Prasun Sinha. 3. 1:Stanford University . 2:The University of Texas at Austin . 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. Moritz Hardt. IBM Research Almaden. Joint work with Cynthia Dwork, Vitaly Feldman, . Toni Pitassi, Omer Reingold, Aaron Roth. Statistical Estimation. Data domain . X. , class labels . Y. Unknown distribution . 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. 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.. Towards an Understanding of Psychokinetic Effects. Österreichische Gesellschaft für Parapsychologie. . . und . Grenzbereiche der . Wissenschaften. . 28. . Juni 2016. Fotini Pallikari. Faculty . of Physics, Department . Nick . Pavlakis. , MBBS, . MMed. (. Clin. Epi. ), . PhD. Royal North Shore Hospital. Sydney University. Outline. Aims of a Phase II study. Design aspects. Disease/population selection. Endpoint selection. General Tools for Post-Selection Inference. Aaron Roth. What do we want to protect against?. Over-fitting from fixed algorithmic procedures (easiest – might hope to analyze exactly). e.g. variable/parameter selection followed by model fitting. in Adaptive Data Analysis. Vitaly. Feldman. Overview. Adaptive data analysis. Motivation. Definitions. Basic techniques. With . Dwork. , . Hardt. , . Pitassi. , . Reingold. , Roth . [DFHPRR 14,15]. New results . 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 . Victor Bahl. Ranveer Chandra. Thomas Moscibroda. Yunnan Wu. Adaptive Channel Width (ACW). Adaptive Channel Width is a key . enabling technology . for Cognitive Radio Networking. Why? . Adaptive Channel Width (ACW). 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.