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    Reserve antibiotics: overcoming limitations of evidence generated from regulatory approval trials by Lorenzo Moja, Mohamed Abbas, Marlieke EA de Kraker, Veronica Zanichelli, Loice Achieng Ombajo, Mike Sharland, Benedikt Huttner

    Published 2025-04-01
    “…Three recommendations are key to enhance the quality and relevance of clinical data underpinning use of last resort molecules on the WHO AWaRe Reserve list active against carbapenem-resistant MDR-B i). separation of pivotal trials from post-approval studies, which should be funded by public programs and de-linked from commercial purposes, ii). development and maintenance of a global infrastructure to conduct post-approval public health focused studies, and iii). development of trial platforms that use efficient, adaptive designs to inform clinical decision making and country level technology appraisal. …”
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