PPT-Two-year Clinical and Echocardiographic Outcomes from the PARTNER 3 Low-risk Randomized

Lowrisk Randomized Trial Michael J Mack MD amp Martin B Leon MD on behalf of the PARTNER 3 Trial Investigators Disclosures Michael J Mack MD ACC 2020 Chicago IL March 2830 2020. Daniel S Bennett MD DABPM. Denver, Colorado USA. “. Any tool is a weapon if you hold it right. ”. Ani. . Difranco. b. 1970. Case: Acute LLE L5 Radiculopathy. 3. 2. y HM (. Ht. 170.2cm, . Wt. 64.5kg. Everolimus. Eluting . Bioresorbable. Vascular Scaffold and the XIENCE . Everolimus. Eluting Stent. Bernard Chevalier. Institut Jacques Cartier, Massy, France. Patrick W. Serruys. Imperial College, London, UK. 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. Overview of Clinical Trials. : Phase I-III. Patricia . Mucci. . LoRusso,. D.O.. Associate Center Director – Innovative Medicine. Yale Cancer Center. <3% of all Cancer Patients Enroll in Clinical Trials. Everolimus. Eluting . Bioresorbable. Vascular Scaffold and the XIENCE . Everolimus. Eluting Stent. Bernard Chevalier. Institut Jacques Cartier, Massy, France. Patrick W. Serruys. Imperial College, London, UK. 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. Andy Coyle, MD. Disclosures. I . do . not . have conflicts of interest to disclose for this learning session. .. I . affirm. that . all discussions of drug use will be consistent with either FDA or compendia (i.e. medical textbook, published medical literature, professional society guidelines) approved indications. Best Beginnings Meeting 1/14/2016. Beth L. Green, Ph.D.. Portland State University. . bgreen@pdx.edu. Jerod. Tarte, M.A.. NPC Research, Inc.. . Research Project Goals & Objectives. Conduct a . Nicolas M. Van Mieghem, MD, PhD. For the SURTAVI Trial . Investigators. 0. Disclosure Statement of Financial Interests. Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) list below. Pharmacy Practice. Jarrod King, Pharm. D. . PGY1 UAMS Managed Care Resident. Ref: Bastian, Hilda. “Statistical . Significance and Its Part in Science . Downfalls.” Bias, . Science Communication. . Wendy . Parulekar. MD, FRCP(C). Wei Tu PhD. Objectives. To review the classification of randomized phase II trial designs. To propose and critique potential  randomized phase II trials designs for a concept in head and neck cancer (case scenario to be presented). Christopher B. Granger, MD. On behalf of the IMPACT-AF . Steering. Committee and Investigators. Background. AF is common (34 million people worldwide). AF is associated with a 5-fold increased risk of stroke. Junjing Lin. [Takeda], Margaret Gamalo [Pfizer], . Ram Tiwari. [BMS]. Expanding Real World Evidence in Pre-market Approvals. What Constitutes Externally Controlled Trials? . Potential Outcomes Framework.