The aim of the guideline is to provide guidance for the development of medicinal products for the treatment of Acute Respiratory Distress Syndrome (ARDS) and/or preventing disease progression. This is the first revision of the Guidance on clinical investigation of medicinal products in patients with ARDS issued in 2006. Updates of the diagnosis criteria for ARDS in 2012 [D0] and 2023 [D1, P1] has subsequent implications for identifying patients both in clinical and research settings. The key requirements are described in terms of study population, (co)primary and secondary efficacy endpoints. Specific issues, including biomarker and/or (sub)phenotype defined drug development and preparedness are addressed for a potential future pandemic due to a viral pathogen that causes ARDS. Furthermore, relevant published methodological guidance documents for decision making (e.g. estimand(s)) were added. This document should be read in conjunction with other relevant European Medicine Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (see section 3)…
