PPT-Clinical Trials Reporting:

NIH Policy amp HHS Final Rule NIH Regional Seminar May 2017 Kristina Elliott MLS Information Specialist ClinicalTrialsgov National Library of Medicine httpsClinicalTrialsgov Agenda Background on ClinicalTrialsgov. 1. Doug Altman. The EQUATOR Network. Centre for Statistics in Medicine, Oxford, UK. “The whole of medicine depends on the transparent reporting of. . clinical trials”. Drummond Rennie, . JAMA. 2001. 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. Elaine M Pascoe, Darsy Darssan, Liza A Vergara. Australasian Kidney Trials Network. The University of Queensland. . Overview. Covariate adaptive randomization. Minimization example. Minimization issues. Towards EDCTP2. 22 July 2014. Melbourne, Australia. Ole F. Olesen, Ph.D., HD. Director of North-North Cooperation,. EDCTP, The Netherlands. Justification for EDCTP2. Objectives. C. linical . development of effective, safe, accessible, suitable and affordable medical interventions for poverty related and neglected . 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. 617TRIALS FOR RELAPSED/REFRACTORY PATIENTS19-021p 2A phase 1/2 study of oral LOXO-305 in patients with previously-treated chronic ymphocytic progression or discontinuation for adverse event18-719p 3A 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.. 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.. 1. Doug Altman. The EQUATOR Network. Centre for Statistics in Medicine, Oxford, UK. “The whole of medicine depends on the transparent reporting of. . clinical trials”. Drummond Rennie, . JAMA. 2001. This webinar is being recorded and will be posted to the CTTI website. All participants are muted upon entry. Questions can be entered in the chat box during the webinar . Questions will be . addressed after . Compensation in clinical trials can mean two distinct things:. w. hen . participants receive monetary or . other benefits.  for their participation in the clinical trial; . or. w. hen participants . 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. . INTRODUCTION. TYPES. PHASES OF CLINICAL TRIALS. DESIGN OF CLINICAL TRIALS. CONTENTS. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.. Selvin Ohene. Director, Clinical Trial Office. . Financial . and Administrative Management of Research. Education and Training Program. October 21. , 2014. Goals of the presentation. 2. RESEARCH. vs. SOC.