ppt课件-bridgingstudiesglobaldevelopment.pptVIP

Bridging Studies ?Global Development W. Joe Shih Biostatistics Dept UMDNJ-School of Public Health Sept. 29, 2006 FDA/Industry Conference, Washington D.C. Clarification Bridging studies: in the context of “ICH E5”. ICH E5 includes drugs and biologics. Not the ‘vaccine immunogenicity bridging trials’ (which are conducted when manufacturing processes or storage conditions are changed after vaccine licensure for improving production yields and vaccine stability or shelf life). New Trend Moving from “Bridging study” toward “Global trial” More fruitful to discuss issues with “Global trial” design and analysis My presentation: ? “Bridging” ? “Global” Purpose of ICH E-5 To facilitate the registration of medicines among ICH regions – US/EU/Japan…” (now expanded to other countries) “To provide guidance on regulatory and development strategies … Extrapolate foreign clinical data and evaluate  influence of ethnic factors Minimize duplication of clinical studies Supply medicine expeditiously to patients Difficulties “Ethnicity” is a not a simple nor precise concept Political and cultural sensitivities (involving international trade of pharmaceuticals - WTO) Lack of consensus even regarding need for  such a guidance ? A compromise concept in E5: Bridging data package = ‘Selected information from the complete clinical data package (CCDP) that is relevant to the population of the new region’ + (if needed) ‘Bridging study(ies) in the new region.’ Difficulties No gold standards of “bridging studies” Heterogeneity among regulatory agency, industry, and academia in the interpretation of the ICH guideline; e.g. what is “extrapolation” of foreign data? how to evaluate the “bridging evidence”? Practical Issues What type of bridging studies are required? Clinical studies? PK/PD studies? Sample size of a bridging study? Not all regions/countries act the same way Market size seems matter very much (unfortunately) Japanese Experience Japanese D