510-512 We appreciate EMA Consider this consideration in that E-R additional language supports predicted PTA, but particularly for it may NOT fully reflect indications where successful response rates knowledge base is due to multitude of less: are “Sponsors potential confounding encouraged to factors. consider E-R analyses, and other When E-R relationships are derived, they may have analyses, for additional application to estimation of support difficult indications treatment effect (e.g., nosocomial sizes and hence, as pneumonia) or those in a support in which NI margins are not selection of well defined (e.g., margins.” bloodstream infections, osteomyelitis, diabetic foot infections, etc…).
510-512 We appreciate EMA consideration in that E-R supports predicted PTA, but it may NOT fully reflect successful response rates due to multitude of potential confounding factors. When E-R relationships are derived, they may have additional application to support difficult indications (e.g., nosocomial pneumonia) or those in which NI margins are not well defined (e.g., bloodstream infections, osteomyelitis, diabetic foot infections, etc…). Consider this additional language particularly for indications where knowledge base is less: “Sponsors are encouraged to consider E-R analyses, and other analyses, for estimation of treatment effect sizes and hence, as a support in selection of margins.”
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx