PPT-Phase I Trial Designs Jud Blatchford, PhD

Colorado School of Public Health January 30 th 2013 Table of Contents Orientation Introduction Components of a Phase I Trial Phase I Trial Designs RuleBased Designs Statistical Designs References. 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. oncology. Shu-Fang Hsu Schmitz. University of Bern, Bern, Switzerland . Phase I trials . First in human. Ever first in human, or for a specific indication, or for a specific combination . treatment, or for a specific dosing schedule. 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. Yeh-Fong Chen, Ph.D. . FDA/CDER/OB/DB3. CBA 2016-2017 Workshop series-3 . Dec. 18, 2016. Disclaimer. This presentation reflects the views of . the author . and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.. Methods in Clinical Cancer Research. February 12, 2015. Effective incorporation of . biomarkers into phase II trials. There are many roles for biomarkers in Phase II trial designs.. Examples of biomarkers with pivotal role in development of new therapies. 2018 . AACR Annual Meeting. April 15, 2018 . Edward Chu, MD. UPMC Hillman Cancer Center. University of Pittsburgh School of Medicine. Drug . “. A. ”. Time (years) . Percent . One Size Fits All Approach. 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 . 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. 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:. 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. 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. 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. Mary Kay Koenig, MD. Associate Vice Chair for Clinical Research. Co-Director for the Tuberous Sclerosis Center of Excellence. Department of Pediatrics. Division of Child & Adolescent Neurology. University of Texas McGovern Medical School. &. . Oversight. . of . clinical. . trials. Dr Greg Fox. University. of Sydney, . Australia. Outline. Cluster Randomized and stepped wedged intervention trials. Ethical standards in clinical trials.