PPT-Application of adaptive designs in clinical trials research

Munya Dimairo Research Fellow in Medical Statistics University of Sheffield UK mdimairosheffieldacuk mdimairogmailcom Twitter mdimairo CREDO Ethiopia 1213 July 2017 Declarations. 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. 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. 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.. 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. Robert A. Beckman, MD. Chair, ADWSG. Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics. Georgetown University Medical Center. eniac1915@gmail.com. ADSWG . Membership: approximately . Virginia A. Caine, M.D.. Associate Professor of Medicine. Division of Infectious Diseases. Indiana University School of Medicine. Director, Marion County Public Health Department. Indianapolis, Indiana. Christopher S. Coffey. Professor, Department of Biostatistics. Director, Clinical Trials Statistical and Data Management Center. University of Iowa. May 28, 2019. In this webinar, we will:. Discuss the importance of adequate study planning for small clinical trials. Page 53 of 60 Ralf‐Dieter Hilgers*, Franz KönigDepartment of Medical Statistics, RWTH Universit Aachen, Pauwelstr 30, D‐ 52074 Aachen, Germany Dr. RalfDieter Hilgers, Department of Medical Statis 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 . 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. Helen Hill. Senior Regional Advisor Clinical Trials . hhill. @liv.ac.uk. www.ctrc.org.uk. . Specialist. . units . to . design, conduct, analyse and publish clinical trials and other well-designed studies. . Why it Matters, How it Affects Power and How to Generate a Randomization List. Brian . Ronayne. Research Statistician. nQuery. Webinar. Host. Agenda. Randomization in Clinical Trials. Common Randomization Strategies. Pro Feature Overview . + GSD Worked Examples. Brian Fox. Research Statistician. nQuery. Agenda. nQuery Features Guide . Group Sequential Design in nQuery . Worked Examples. Questions welcome throughout.