lecture_14

Assessment of safety is critical during this phase

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Unformatted text preview: sment of safety is critical during this phase Typically 3 sites with about 3 subjects per site. 11/19/07 ME 128 28 Phase II Successful completion of Phase I results in design improvements and revisions if needed Regulatory review typically is needed to enter Phase II to expand the study with more sites and subjects Effectiveness is assessed during this phase. Typically 3 or more sites with about 10 subjects per site 11/19/07 ME 128 29 Phase III Successful completion of Phase II results in the finalization of the design Regulatory review is needed to enter Phase III to expand the study with more sites and subjects Effectiveness is statistically assessed during this phase. Typically 3 or more sites with about 30 subjects per site 11/19/07 ME 128 30 Phase IV Post marketing studies are conducted to better understand customer needs These are not intended to address safety of effectiveness May be used to help support Marketing and Sales programs These studies are not conducted under IDE. 11/19/07 ME 128 31 National Institute of Dental and Craniofacial Research NATIONAL INSTITUTES OF HEALTH www.nidcr.nih.gov Adapted from a slide presentation developed by the National Cancer Institute, for its Cancer Clinical Trials Education Series. 11/19/07 ME 128 32...
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