PPT-Evaluating an Adaptive Clinical Trial with Quantitative Endpoints, Sample Size Re-estimation,

By Harrison Reeder Mentor Dr Kathryn Chaloner Iowa Summer Institute in Biostatistics Outline What exactly does that title mean Basic Clinical Trial design Interim Monitoring for Efficacy. -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. 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 . David Morgan (King’s College, London / Consultant – formerly Ipsen). Nilani. . Liyanage. (Ipsen). Alison Langley (Consultant – formerly Ipsen). PSI Scientific Meeting on Sample Size Re-estimation: London: 2 November 2016. Designing your trial for success. Elizabeth Garrett-Mayer, PhD. Professor of Biostatistics. Hollings Cancer Center, Medical University of South Carolina. Golden rule of clinical trials. “Perform a study that will answer an important clinical question with reasonabl. 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. David Morgan (King’s College, London / Consultant – formerly Ipsen). Nilani. . Liyanage. (Ipsen). Alison Langley (Consultant – formerly Ipsen). PSI Scientific Meeting on Sample Size Re-estimation: London: 2 November 2016. 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. 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. . Natalie Dimier and Sue Todd. University of Reading. Pharm Stat. 2017 Sep;16(5):322-333. Agenda. Context. Motivation for the research. Investigation. Set-up. Results. Conclusions. Remaining Questions. Brad Rechtzigel Kohei Osterloth. "The gold standard for evaluating a new intervention" . -Allen Hackshaw. Main topics. What is Phase III?. What are the objectives?. What are the outcomes? . How large should the sample sizes be ?. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Introduction to Adaptiv. e Design. Adaptive Design Regulatory Context. Sample Size Re-estimation & Worked Example. of EMA authorized . biosimilars. Session “Biosimilar Development”, 15 May. Johanna . Mielke, Bernd Jilma. , Franz Koenig, . Byron . Jones. Franz König. Medical University of Vienna. Section of Medical Statistics. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Adaptive Designs and Sample Size Re-estimation (SSR). Blinded Sample Size Re-estimation .