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. NDEPENDENT ARIABLE Type of insulation EVELS OF NDEPENDENT ARIABLE AND UMBERS OF EPEATED RIALS No insulation Control Cotton Wool Nylon 3 jars 3 jars 3 jars 3 jars EPENDENT ARIABLE AND OW EASURED Change in temperature of water in jar measured in degre Protein Extraction. Mechanical grinding. Detergents. Other buffers. Sonication. http://www.piercenet.com/browse.cfm?fldID=FA97D803-6953-48E4-A7BD-6947D35FE83B. Considerations for mass spectrometry. Salts and buffers in high concentrations can cause ion suppression and adduct formation in electrospray mass spectrometry. 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. 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. 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. Methods in Clinical Cancer Research. February 12, 2015. Effective incorporation of . biomarkers into phase II trials. There are many roles for biomarkers in Phase II trial designs.. Examples of biomarkers with pivotal role in development of new therapies. IM4Q Annual Statewide Conference 2016. Guy . Caruso - Institute on . Disabilitie. s. . Nancy . Cohlhepp. . & Kathy . Glosser - Clarion Vocational . Services;. Jennifer . Harniman-Crangle - Chester County Department of . Oral . Antidiabetics. Adverse CV events led the FDA to require. . demonstration of CV safety for new glucose-lowering drugs. UGDP study: tolbutamide discontinued due to increased CV mortality vs other treatment groups. 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: 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 . Anna Nowak. MBBS FRACP PhD. Chair, . CoOperative. trials Group for . NeuroOncology. (COGNO). Director, National Centre for Asbestos Related Diseases. “The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary”.. 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.. Guide to Two-Stage . IIa. Designs and . IIa. /IIb using MCP-Mod. Denis Desmond. Research Statistician. nQuery. Webinar. Host. Agenda. Phase II Designs. Phase . IIa. Phase . IIa. /IIb with MCP-Mod. Discussion and Conclusions.