PPT-Precision Medicine Clinical Trial Designs

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. 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. Apostolia M. Tsimberidou, . MD, PhD. Professor . Investigational Cancer Therapeutics. Incorporation of Levels of Evidence into Variant Reporting/Clinical Practice. Implementation of CAP, AMP, ASCO recommendations. Monday, November 14, 2016. Session Objectives. Understand . Precision Medicine and why a diverse cohort is crucial for success. Describe the nuanced issues in Precision Medicine and genetic research as applied to Native populations. A view from the AspECT trial. Gavin Reilly. Centre for Statistics in Medicine. University of Oxford. Introduction. Primary Outcomes: . Does aspirin intervention . result . in a decreased rate of all causes of mortality or conversion rate from Barrett’s metaplasia to adenocarcinoma or high grade dysplasia . 1. 2015 Precision Medicine Initiative: . Two Components: Cancer & National Cohort. “. An emerging approach for disease prevention and treatment that takes into account people’s individual variations in genes, environment, and lifestyle”. CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE Introduction. How Has Precision Medicine Changed the Treatment Landscape in Oncology?. Selection of Biomarkers in Drug Development. Methods to Identify Driver Mutations. Which Method Should Be Used?. 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. Karen L. Edwards, . PhD. Professor, Dept. of Epidemiology. School of Medicine. University of . California, Irvine. Irvine, CA. Outline. Two National Initiatives . Precision Medicine Initiative . Cancer . 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:. (PMAL) Consortium and Associated Trials. 2016. CONFIDENTIAL. The new name for . Leukaemia. & Lymphoma Research. Tackling Diffuse Large B-cell Lymphoma. 2. Clinical Problem. Standard of care, RCHOP, results in cure rates around 75%. 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. &. . Oversight. . of . clinical. . trials. Dr Greg Fox. University. of Sydney, . Australia. Outline. Cluster Randomized and stepped wedged intervention trials. Ethical standards in clinical trials. Owen Tan. 1. , Deborah Schofield. 1. , Rupendra Shrestha. 1. 1. GenIMPACT: Centre for Economic Impacts of Genomic Medicine, Macquarie Business School, Macquarie University, Australia.. Presenting at: .