PPT-Core Clinical Research Concepts and Issues

Al M Best PhD Virginia Commonwealth University Task Force on Design and Analysis in Oral Health Research Satellite Symposium AADR Boston MA March 9 2015 Outline Core Concepts Defining the research question. REVIEW Estudos cl Seeking New Models of Care “Treasures”. This poster was inspired because a growing number of health care providers and payers are seeking to share of the “treasure” of health care savings by becoming part of new models of accountable, collaborative care. In a sense, we are all looking for the “treasure” of finding more effective models of care. . Medical University of South Carolina (MUSC). Charleston, South Carolina. USA. Master of Science in Clinical Research (MSCR). Program . Design based on US National Institute of Health (NIH) definition of Clinical Research with modifications based on NIH and NCRR core competencies. Agency for Healthcare Research and Quality. Technical Assistance Call. April 14, 2011 . Conference Call Agenda. Overview of the FOA. Frequently asked questions. Open forum . Summary: Research Center for Excellence in Clinical Preventive Services . 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. 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 Aim. 2. 05/11/2018. Giant cell arteritis (GCA): most common primary systemic vasculitis in western countries. Lifetime risk: 1.0% for women and 0.5% for men over the age of 50 years. Severe potential complications: sight loss, stroke, cranial nerve palsy, large-vessel aneurysms, vascular . 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. Dr. Haider Raheem Mohammad. Research ethics and clinical trials . in therapeutic . research. All medicines employed in pharmacy are subjected to two linked phases of activity: discovery and validation. Some botanical species like the opium poppy were discovered by chance to have medicinal value some 2000 or more years ago and validated by simple trial and error. The vast majority of the more potent and selective drugs used in the UK today have been subjected to systematic processes of discovery, evaluation, testing and approval. Since the introduction of voluntary assessment by the Committee on Safety of Drugs in the UK in 1964, formal regulatory approval of all medicines has become rigorous and mandatory.. a. nd Translational Research Core. About the CHCRP. Founded in 1991. Cancer and Hematology-based Trials: . Cancer Treatment, Prevention or Early Detection. Symptom Management (symptoms caused by disease or by treatments). Nine interrelated Projects supported by Three Ministries Development Promotes development of innovative drugs, and strengthens support functions aimed at new drug discovery. Development Develops medic Institute . for Clinical and Translational Research. And. Translational Laboratory Cores. Craig Hendrix, MD, . ICTR/CFAR . Lab Core. . Director. chendrix@jhmi.edu, . 410-955-9707. Curt Reynolds, MAS, . Hall. March . 16, 2021. Agenda. Introductions – Drs. . Tim . Stemmler. and Phil Levy. Clinical Research Support Services Presentations –Directors. Breakout Rooms – One breakout room for each . CCR uses outside contracts for various activities including production of reagents, procurement of tissues, advisory and technical services.. Two types of contracts in the federal system: . R&D; directly support primary research .