PPT-Phase I and Phase II trial design in

oncology ShuFang 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. 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. Module 3: Overview of Prevention Research. www.icad-cisd.com. UNDERSTANDING THE RESEARCH PROCESS. Clinical Trials Process. Preclinical. Phase I. Phase II. Phase IIB. “Test of Concept”. Phase III. of Developments in the Management of Hyperkalemia. Program Goals. Recent Clinical Trial Data on Potassium Binders: Patiromer. OPAL-HK . Phase 3 Pivotal Study Design. OPAL-HK . Initial Treatment Phase. 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. Christopher . Jennison. , University of Bath. Robert A. Beckman, Daiichi Sankyo Pharmaceutical Development and University of California at San Francisco. Agenda. TOPIC 1: Where do subgroups come from? Empirical data or basic science? How does this vary as a function of developmental stage? . 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.. Colorado School of Public Health. January 30. th. , 2013. Table of Contents. Orientation. Introduction. Components of a Phase I Trial. Phase I Trial Designs. Rule-Based Designs. Statistical Designs. References. 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. 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 . The Role of Skin as an . Immune Organ. The Skin: Our First Line of Defense. Immune Cells of the Epidermis. The Skin as a Barrier. Epidermis. Allergen-Specific Immunotherapy Induces a Treg-Mediated Immune Response. 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. Guide to Two-Stage . IIa. Designs and . IIa. /IIb using MCP-Mod. Denis Desmond. Research Statistician. nQuery. Webinar. Host. Agenda. Phase II Designs. Phase . IIa. Phase . IIa. /IIb with MCP-Mod. Discussion and Conclusions. 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. A Feasibility Study. SciSIP. PI Conference, September 2012. Ernst R. Berndt. Iain M. Cockburn. MIT, Boston University, and . National Bureau of Economic Research. What?. Analysis of trends in costs of doing clinical trials.