PPT-Subteam : Bayesian Statistics and Adaptive Design in MAPPs

Chairs Bob Campbell TBD Zoran Antonijevic Subteam Objectives Establish and promote the role for Bayesian statistics and Adaptive Design as key drivers of Medicine Adaptive Pathways to Patients MAPPs. -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. 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 . Joseph J. Glavan. glavan.3@wright.edu . Joseph W. . Houpt. Wright State University. How are stimuli processed?. Multiple sources of information:. Color . and shape. Facial features. Curved and straight text features. Carrie Deis. Nadine Dewdney. Phase I clinical trials. Standard Designs. Adaptive Designs. Bayesian Approach. Traditional vs. Bayesian. Hybridization. FDA Guidance. Conclusion. Overview. Conducted to determine toxicity for the dosing of the new intervention. Saving Time, Saving Lives. Thursday, 4 June 2015, 11:00-12:30. Cercle. . Cité. , Grand Auditorium, Luxembourg. 1. Jeremy Haigh, EFPIA. Moderator. 2. Introduction. Meeting Agenda. 11:00 - 11:05 Introductions. . *. . Date: . 27 Oct 2015 . *. . Version:. . Final. . Better Science, Better Health: New Healthcare Models. New Data Models: Managing Uncertainty and Leveraging New Sources of Evidence. www.efpia.eu. JSM . 2017. Baltimore, MD. DIA-BSWG . F2F, Baltimore 2017. 1. Acknowledgments. Face-to-face planning committee. Freda Cooner, Sanofi. Satrajit . Roychoudhury. , Pfizer. Amy Xia, Amgen. Karen Price, . 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 . Experiences and . Assessments. eCOTS. 2012. Oded Meyer. Candace . Thille. Marsha Lovett. Carnegie . Mellon . University. The Effort: Carnegie Mellon. ’. s Open Learning Initiative (OLI) . Scientifically. In this class we will review . how statistics are used to . summarize data, special probability distributions, . their . use in simple applications using Frequentist and Bayesian . methods, and Monte Carlo techniques. Jingjing Ye, PhD. BeiGene. PSI Journal Club: Bayesian Methods. Nov. 17, 2020. Outline. Background . Using a case study to illustrate potential useful Bayesian analysis. Analysis and monitoring. Design study. 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. 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.