PPT-Phase II designs in Oncology

Nick Pavlakis MBBS MMed Clin Epi PhD Royal North Shore Hospital Sydney University Outline Aims of a Phase II study Design aspects Diseasepopulation selection Endpoint selection. Phil clin Psych students Elective international student teaching Public Cancer Awareness Programmes Dr Suraj Manjunath Associate Professor Head of Department Dr Shiva Kumar K Assistant Professor Dr Rakesh S R amesh Assistant Professor Dr Tanveer Huss 0 Phase 1 Phase 2 Phase 3 Therapeutic area Cardiovascular - Metabolics Oncology Others  Prasugrel (JP) ( CS - 747 / ischemic stroke / anti - platelet agent )  Prasugrel (US) ( CS - 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. Gary E. Foresman, MD. February 2012. “In 2010, about 600,000 Americans, and more than 7 million humans around the world, will die of cancer. . In the United States, 1 in 3 women and 1 in 2 men will develop cancer during their lifetime. . Challenging Tradition. Chia-Chi (Josh) Lin, MD, PhD . 林家齊. Director of Phase I Center, Department of Oncology, National Taiwan University Hospital. Clinical Associate Professor, Graduate Institute of Oncology, National Taiwan University College of Medicine. 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. Matthew Marston, . Pharm.D. ., BCPS. Miller Drug, LLC. Oral Oncolytics. Objectives. Identify . opportunities and challenges associated with the recent growth of the oral oncolytic market. .. Describe . 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 . Medical Oncology Updates Presentation by Mary Hill Library Manager The Christie NHS Foundation Trust Putting it into context Cancer specialist hospital with strong research focus A lot of research fellows & one suggested they wanted Elizabeth Garrett-Mayer, PhD. Director, Division of Biostatistics and . Research Data . Governance. Center for Research and Analytics (CENTRA). American Society of Clinical Oncology (ASCO). Alexandria, VA. J. Bennouna. 1. , A. Sibille. 2. , C. Debruyne. 3. , B. Colinet. 4. , I. Demedts. 5. , S. Derijcke. 6. , L. Greillier. 7. , J. Jurgens. 8. , H. Lena. 9. , D. Moro-Sibilot. 10. , M. Pérol. 11. , X. Quantin. Shabbir. M.H. . Alibhai. , MD, MSc, FRCP(C). . Professor,. Dept. of Medicine, University Health Network and University of Toronto. Research Scientist, CCSRI. Learning objectives. To review cancer epidemiology in older adults. Dr Ollie Minton . National Picture. 29% . NHS spending is on patients in the . last year of their life. 1:3 . of the adult inpatient population is in the last year of their life. 1:10. is in their last admission. PTA. Students. Total. APTA Oncology. 1314. 74. 1130. 2,518. Balance & Falls SIG. 51. Immune System Disorders SIG . . 21. Hospice & Palliative Care SIG . . 24. Lymphatic Diseases SIG. 62. Pediatric SIG.