PPT-Clinical 101: Clinical trial endpoints:

Selection analysis and interpretation Elizabeth GarrettMayer PhD Hollings Cancer Center Medical University of South Carolina December 10 2013 San Antonio Breast Cancer Symposium Cancer Therapy and Research Center at UT Health Science Center . Clinical Trial Endpoints Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Clinical/Medical Additional copies are available from:  Office of Trainin David N. Assis, MD. Assistant Professor of Medicine. Yale University. I have no disclosures relevant to this presentation.. Clinical Trials in PSC. PSC is a rare disease . 32,000 patients in the US. PSC has no proven and approved treatment. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. Generated by Mobile Technology for . Use in Clinical Trials*. *The term “clinical trial” is used here to refer to studies done to support regulatory approval for marketing. . Source: Clinical Trials Transformation Initiative’s . FDA Perspective. Marco Cannella, PhD. Senior Lead Reviewer . Cardiac Electrophysiology Devices Branch. FDA – CDRH – Office of Device Evaluation. ISCTR Consensus Summit. San Diego, California. September 21, 2018. 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 . Cynthia Monahan, MBA, . CIP. CRC . IRB Director. Karla . Damus. , PhD, MSPH, MN, RN, FAAN. Clinical Research Regulatory and Education Manager Administrator, BMC/BUMC ClinicalTrials.gov . NIH Policies. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . RWD. Frank W. Rockhold, PhD. Professor of Biostatistics and Bioinformatics. Duke University Medical Center. Duke/Stanford CEC Summit. September 26-27, 2018, Chicago, Il. Disclosure. Statement – . CUP . . Harpreet S. Wasan. Consultant / Reader in Medical oncology. Department of Cancer Medicine. Hammersmith Hospital,. . Imperial College London. h.wasan. @. imperial.ac.uk. Microarray . Identifies . Karen-Sue Carlson, MD, PhD. Associate Professor of Medicine. Division of Hematology and Oncology. Section Head and Medical Director of Acute Care. Medical College of Wisconsin. Milwaukee, WI. What are clinical 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. 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. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4.