PPT-Comments on Methodological Challenges in Clinical Trials for CIPN

n ges in Clinical T rials for CIPN Michael P McDermott PhD University of Rochester Medical Center Measurement of outcome Strategies for statistical analysis Defining the study population. Cynthia M. Otto, DVM, PhD DACVECC. Associate Professor of Critical Care. What is a clinical trial?. A prospective evaluation in which the factor of interest is controlled by the investigator. RANDOMIZATION. Medical Research Council clinical trialsseries 2 methodological and ethical considerationsCluster randomised trials:Methodological and ethical considerationsclinical trials series 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 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. Virginia A. Caine, M.D.. Associate Professor of Medicine. Division of Infectious Diseases. Indiana University School of Medicine. Director, Marion County Public Health Department. Indianapolis, Indiana. Head, Palliative Care Research. Division of Cancer Prevention. NCI: Programmatic Overview of CIPN Portfolio. . March. , 2017. Objectives. Provide an overview of the NCI Community Oncology Research Program (NCORP). Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . Lynn Howie, MD, Medical Officer, DOP1. Supportive Care is Crucial for . Cancer Treatment. Antiemetics. Growth factors. Bone health agents. Agents to reduce mucositis. Anti-diarrheals. Supportive care therapies reduce symptoms and side effects allowing for improved delivery of chemotherapy agents, many of which are given with curative intent . March 23, 2017. Jennifer Gewandter, PhD, MPH. Presentation objectives. Outline the design challenges and issues to consider when designing a CIPN study during chemotherapy. Summarize how published RCTs have addressed these design challenges. over 55 years of neuropathic toxicity: . if not now, when do we take . aaacttion. . Joanna M . Brell. , MD. Clinical Associate Professor of medicine. Case Western Reserve University. Associate Director Cancer Center for clinical research. Helen Hill. Senior Regional Advisor Clinical Trials . hhill. @liv.ac.uk. www.ctrc.org.uk. . Specialist. . units . to . design, conduct, analyse and publish clinical trials and other well-designed studies. . 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..