PPT-CLINICAL TRIALS : TYPES AND DESIGN

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. CLINICAL TRIALS. Presented by. Y.SRUTHI. M.Pharmacy. –II . sem. DEPARTMENT OF INDUSTRIAL PHARMACY. UNIVERSITY COLLEGE OF PHARAMACEUTICAL SCIENCES. KAKATIYA UNIVERSITY. WARANGAL-506009. Contents. Introduction on Drug Development Process. the statistics right for integrative research involving . Ayurveda. Ashwini Mathur. (Novartis Healthcare Pvt. Ltd, Hyderabad). August 1, 2013, . Samyukti. 2013. 1. Disclaimer/Acknowledgements. All views expressed are authors’ and do not reflect the views of Novartis.. trials. Kinza Waqar. Assisitant. Clinical Research Associate. Shifa. Clinical research Center. (SCRC). Contents:. What are RCTs?. General Principals of RCTs. Randomization: The strength of RCTs. Allocation concealment . Acknowledgements to collaborators:. Steven . Julious. , Susan Todd, Jon Nicholl, and Jonathan . Boote. #ICTMC2015. Meandering journey towards routine trial adaptation: survey results on barriers to use of adaptive designs in confirmatory trials. William Petros, PharmD, FCCP. Professor, Schools of Pharmacy & Medicine. Associate Director for Anticancer Drug Development. Mary Babb Randolph Cancer Center. West Virginia University. Outline. Rationale for Clinical Trials. Yeh-Fong Chen, Ph.D. . FDA/CDER/OB/DB3. CBA 2016-2017 Workshop series-3 . Dec. 18, 2016. Disclaimer. This presentation reflects the views of . the author . and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.. Christopher S. Coffey. Professor, Department of Biostatistics. Director, Clinical Trials Statistical and Data Management Center. University of Iowa. May 28, 2019. In this webinar, we will:. Discuss the importance of adequate study planning for small clinical trials. 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.. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . Non-randomised controlled trial. Randomised controlled trial . Parallel group. Cross-over. Single or double blind. Superiority or non-inferiority trial. 2. Trial design types. In a clinical trial design, there are a number of different types of comparisons that can be included:. D. esigns. 2. Steps in clinical . d. evelopment . p. rograms. Phase I:. . Studies on . dosing. Phase . III:. . Assess . therapeutic effect and benefit-risk in patients of candidate vs. standard of . What you should know about study design. Demonstrated on . Head of Statistics. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. AGENDA. Adaptive Designs in Confirmatory Trials. Primer on Sequential Design Methods . and Design Choices. Ronan Fitzpatrick. Lead Statistician. nQuery. Webinar. Host. Agenda. Sequential Design Overview. Issues in Sequential Design. Group Sequential Design. 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. .