PPT-What is it like to participate in a clinical trial?

KarenSue Carlson MD PhD Associate Professor of Medicine Division of Hematology and Oncology Section Head and Medical Director of Acute Care Medical College of Wisconsin Milwaukee WI What are clinical trials. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. (aka---how to know where to look and who to call). GIST. Rare disease, 5000-7000 new cases of GIST every year . Compare 230,000 new invasive breast CA cases/year. GIST studies tend to be opened at fewer sites . David N. Assis, MD. Assistant Professor of Medicine. Yale University. I have no disclosures relevant to this presentation.. Clinical Trials in PSC. PSC is a rare disease . 32,000 patients in the US. PSC has no proven and approved treatment. (aka---how to know where to look and who to call). GIST. Rare disease, 5000-7000 new cases of GIST every year . Compare 230,000 new invasive breast CA cases/year. GIST studies tend to be opened at fewer sites . Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. Cynthia Monahan, MBA, . CIP. CRC . IRB Director. Karla . Damus. , PhD, MSPH, MN, RN, FAAN. Clinical Research Regulatory and Education Manager Administrator, BMC/BUMC ClinicalTrials.gov . NIH Policies. T. he . trial sponsor . compiles . a detailed clinical study report (CSR. ) after each clinical trial. . This report follows . a format laid down by the regulatory . authorities.. The CSR can be hundreds of pages long.. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Mary Kay Koenig, MD. Associate Vice Chair for Clinical Research. Co-Director for the Tuberous Sclerosis Center of Excellence. Department of Pediatrics. Division of Child & Adolescent Neurology. University of Texas McGovern Medical School. CUP . . Harpreet S. Wasan. Consultant / Reader in Medical oncology. Department of Cancer Medicine. Hammersmith Hospital,. . Imperial College London. h.wasan. @. imperial.ac.uk. Microarray . Identifies . PERFUSE Medical Research &. Clinical Trial Course. Clara Fitzgerald, MPH. The Importance of Clinical Trial Protocols. The Clinical Trial Protocol is the complete written description of, and scientific rational for clinical research studies. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4. A Feasibility Study. SciSIP. PI Conference, September 2012. Ernst R. Berndt. Iain M. Cockburn. MIT, Boston University, and . National Bureau of Economic Research. What?. Analysis of trends in costs of doing clinical trials.