PPT-Safety Considerations in Phase 1 Trials

Sumathi Nambiar MD MPH Director Division of AntiInfective Products November 7 2016 Outline General considerations with clinical trials early in development Predictable and unpredictable adverse reactions. Module 3: Overview of Prevention Research. www.icad-cisd.com. UNDERSTANDING THE RESEARCH PROCESS. Clinical Trials Process. Preclinical. Phase I. Phase II. Phase IIB. “Test of Concept”. Phase III. OnCology. drug development. Jan 22, 2015. Methods in Clinical Cancer Research. Expansion Cohorts. What is an expansion cohort? Generally, a cohort of patients enrolled at the MTD or RP2D after it is defined based on a small number of patients at the dose. Challenging Tradition. Chia-Chi (Josh) Lin, MD, PhD . 林家齊. Director of Phase I Center, Department of Oncology, National Taiwan University Hospital. Clinical Associate Professor, Graduate Institute of Oncology, National Taiwan University College of Medicine. 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.. . Hong Li. (Acknowledgement: some slides from Rick Chappell, . Univ. of . Wisc. ). Historically, DOSE FINDING study. Determine maximal tolerated dose (MTD). Recommend dose for Phase II clinical trials. Changing Landscape of Therapeutic Options. Burden of AD in Adults. Dupilumab Phase 3 Trials. Study Design. Dupilumab Phase 3 Trials. Primary Efficacy Data. Dupilumab Phase 3 Trials. Secondary Efficacy Data. Phase I Trials: Statistical Design Considerations Elizabeth Garrett-Mayer, PhD (Acknowledgement: some slides from Rick Chappell, Univ of Wisc ) Historically, DOSE FINDING study Classic Phase I objective: Consultant Pediatrcian,Pedicare, Ratu Road,rch_sssidana@rediffmail.com. Alleviation of Pain Associated Marina Di Marco. Principal Neuromuscular Physiotherapist. The changing landscape of research in DMD. Emily Crossley and Alex Johnson (co-founders of Duchenne UK and parents of children with DMD) were disappointed that clinical trials were being turned down in the UK because of lack of capacity.. Outline. Review of a phase I trial. What is a phase II trial?. Phase II trial process. Standard trial designs. Innovative trial designs. Phase II trial examples. Guess that trial. Phase II thalidomide study. Elizabeth Garrett-Mayer, PhD. Director, Division of Biostatistics and . Research Data . Governance. Center for Research and Analytics (CENTRA). American Society of Clinical Oncology (ASCO). Alexandria, VA. 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 . Founder, President and CEO. How the PATH Act Can Rejuvenate Antibiotic R & D. . VOLUME. TIME. Need to Increase . Investment. in Antibiotics. DEMAND. for NEW ANTIBIOTICS:. Increasing Antibiotic Resistance to.