PPT-A Study Among Key Stakeholders and the Use of Real World Data and Evidence in Clinical

February 15 2017 Clinical Innovation Seminar Mary Jo Lamberti PhD Senior Research Fellow Tufts CSDD About Tufts CSDD                        An independent academic nonprofit research group at Tufts . Prepared for:. Agency for Healthcare Research and Quality (AHRQ). www.ahrq.gov. This presentation will:. Characterize the primary uses and users of the scientific evidence that will be generated by the study (stakeholders) and how the evidence may be used. What Can Go Wrong?. Skeptic’s Toolbox. 2012. Harriet Hall, MD. The . SkepDoc. Overview. What constitutes evidence in medicine?. What can go wrong in clinical studies?. Why even “evidence-based medicine” is flawed.. How Do Real-World Data Fit In? . Program Goals. VTE Is a Leading Cause of Death Worldwide. NOACs: VTE Clinical Trials. Real-World Data. XALIA. A Prospective, Noninterventional Study. EINSTEIN-DVT and XALIA: Outcomes. SIG, 22.05.12. A. Gaughan. Director, Payer and RWE Informatics | AstraZeneca. A Pharma Perspective. In the Beginning...... One data customer, with predictable habits. 2. . And now...... Multiple data customers, many different tastes..... iiacross all agencies and organisations working with education systems in developing countries Robust research and evaluation generates the evidence required to form judgements deliberate options and . Sebastian Schneeweiss, MD, ScD. Professor of Medicine and Epidemiology. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine. Brigham and Women’s Hospital, Harvard Medical School, Boston. ) is . about systematically . reviewing, appraising, and using clinical research findings to aid the delivery of optimum clinical care to patients. . Patient . knowledge of . EBM . is important because it enables them to make more informed decisions about disease management and treatment. . What is RWE?. RWE, real-world evidence. .. 1. Food and Drug Administration. RWE. https. ://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence . (Accessed July 2019).. 1 , PHS, and HMS RESOURCES AND ENVIRONMENT The Massachusetts General Hospital has a long, rich, and diverse tradition of excellence in clinical research that continues to expand today. The extensiv Clinical trials . are required in the development of . new . medicines and improved treatments . for . patients. . The . information that clinical trials generate on the efficacy and safety of . treatments . -differences from Basic Research-. Tetsuo Ashizawa, M.D.. NIH definition of clinical research. Research with human subjects that is:. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:. Disclaimer. This panel is moderated by Dr. Delphine Courmier, Executive Director Global Head of Pricing. & Biosimilars Market Access at Organon. The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon.. MedTech case study 2: . Sleepio . Impact on patient and system outcomes. Technology. Sleepio. is a digital health technology designed to support user's self-management of insomnia. . It is accessed mainly through its website with iOS and . Part I:Real World Evaluation Approaches . May 16, 2012 . YALE-GRIFFIN PREVENTION RESEARCH CENTER. David L. Katz, MD, MPH. Valentine Yanchou Njike, MD, MPH. Jesse Reynolds, MS. Engage stakeholders . Describe the program .