PPT-Recent U.S. Regulatory Efforts on Complex Innovative Clinical Trial Design

John Scott PhD Director Division of Biostatistics Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research FDA Disclaimer This presentation reflects the views of the author and should not be construed to represent FDAs views or policies. Brad DeCamp. SOTA. Ohio Mental Health & Addiction Services. Changes in philosophical approach towards . MAT. “Healthy tension” between abstinence only and medication. Evolution of medications. Sponsor Responsibilities . Based on ICH . E6. GCP Guidance (Section. 5). Purpose:. To . provide an overview of Sponsor Responsibilities . to study sites. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site . Adverse Drug Reactions (ADR). All . noxious . and unintended . responses to a medicinal product related to any . dose should . be . considered adverse . drug reactions. . Adverse Event (AE). Any untoward medical occurrence in a patient or clinical investigation . Director of Research Operations. Neurological Clinical Research Institute (NCRI). Massachusetts General Hospital (MGH). Dixie Ecklund, RN, MSN, MBA, CCRC. Director of Operations. Clinical Trials Statistical & Data Management Center. History, Current Regulations , and Future Considerations by Kalindi Naik Project Submitted to the School of Health Sciences Eastern Michigan University in partial fulfillment of the requirements for non-. inferiority. . trial. design in . pediatric. multiple . sclerosis. Marius Thomas, Dieter Haering . 21 . October. 2021. Joint PSI, EFSPI & ASA BIOP . Webinar on . Complex. Innovative Designs. Nanosimilars. Beat . Flühmann. Global Lead NBCD . Vifor. . Pharma. Ltd. Steering. committe . member. . of. . the. NBCD Working Group. NBCD:. A. n increasingly important drug class. 2. Nanosimilars. of. human . challenge trials. Nele Berthels. FAMHP Vaccine Symposium. , . BRUSSELS, . 9 September 2017. Disclaimer. This presentation . reflects . my . personal point of . view, . and . not necessarily the . Senior Product Manager for Health and Life Sciences. Sam.Gardner@JMP.com. What is JMP Clinical?. JMP Clinical is a focused and specialized product for Clinical Trial data review. . We give users “straight out-of-the-box” functionality to do thorough reviews of clinical trials at the study, site, and subject level. C. Karen Jeans, . PhD, CCRN, CIP. VHA Office of Research and Development (ORD). 2023 IRB and Research & Development (R&D) Committee Chairs Workshop. February 7-9, 2023. Objectives. Define the term “decentralized trials”.. 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. 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.. Inês Reis – Statistical assessor MHRA. PSI Career Young Statistician Webinar Session – 9 June 2020. Disclaimer. The views expressed in this presentation are my own and should not be understood or quoted as being made on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA) or any other entity.. By: Harrison . Reeder. Mentor: Dr. Kathryn . Chaloner. Iowa Summer Institute in Biostatistics. Outline. What exactly does that title mean?. Basic Clinical Trial design. Interim Monitoring for Efficacy.