PPT-| International Clinical Trials Registry Platform

1 Innovation of New Antibiotics WHO Technical Briefing Seminar Zafar Mirza 04 November 2014 WHO Geneva Public Health Innovation and Intellectual Property EMP International Clinical Trials Registry Platform. Introductions. NIST. Office of Data and Informatics (ODI) of the Material Measurement Laboratory. Robert Hanisch, director. Ray . Plante. , interoperability expert. ODI has responsibility for ~100 Standard Reference Data products and leads NIST efforts to improve data dissemination. Protocol=study plan which details what researchers will do in the study. It describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. . Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. Towards EDCTP2. 22 July 2014. Melbourne, Australia. Ole F. Olesen, Ph.D., HD. Director of North-North Cooperation,. EDCTP, The Netherlands. Justification for EDCTP2. Objectives. C. linical . development of effective, safe, accessible, suitable and affordable medical interventions for poverty related and neglected . 9 May 2017. Theodore . Lystig. , PhD. Director, Corporate Biostatistics.  . Strategic & Scientific Operations.  . Medtronic  . Public-Private Partnership. Co-founded by Duke University & FDA . 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 617TRIALS FOR RELAPSED/REFRACTORY PATIENTS19-021p 2A phase 1/2 study of oral LOXO-305 in patients with previously-treated chronic ymphocytic progression or discontinuation for adverse event18-719p 3A History, Current Regulations , and Future Considerations by Kalindi Naik Project Submitted to the School of Health Sciences Eastern Michigan University in partial fulfillment of the requirements for By: Caitlin Vinyard. HSC Sponsored Projects Office. What is a Clinical Trial?. Clinical trials . or Clinical Study are defined in concurrence with NIH and Office of Human Protections (HRPO) guidelines. . This webinar is being recorded and will be posted to the CTTI website. All participants are muted upon entry. Questions can be entered in the chat box during the webinar . Questions will be . addressed after . Leanne Madre, CTTI . Cindy Geoghegan, Individual Patient Representative . Virginia . Nido. , Genentech, a Member of the Roche Group. February 21, 2019. Disclaimer. The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative. Compensation in clinical trials can mean two distinct things:. w. hen . participants receive monetary or . other benefits.  for their participation in the clinical trial; . or. w. hen participants . Covered in this presentation. Basic information about clinical trials. Information about finding a clinical trial. Information about participating in or leaving a clinical trial . Vision. Mission. Make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards.. Lupus Conversations Clinical Trials Popular Opinion Training Module 1 . 1. of 9. Boston Team: . Candace Feldman, MD, ScD; Jessica Williams, MD, MPH; Elmer Freeman (CCHERS), Kreager Taber, BA. Chicago Team.