Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline

This document provides guidance for the evaluation of new medicinal products for prevention and treatment of acute respiratory distress syndrome.

Keywords: Acute respiratory distress syndrome (ARDS), biomarker, phenotype, pandemic preparedness

Current version

Guideline on clinical investigation of medicinal products in the treatment of patients with Acute Respiratory Distress Syndrome - Revision 1

Adopted Reference Number: EMEA/CPMP/EWP/504/97 Rev 1 Legal effective date: 01/04/2007

Document history - Revision 2

Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Adopted Reference Number: EMA/58320/2025 rev. 2 Legal effective date: 01/06/2026

Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Draft: consultation closed Consultation dates: 28/02/2025 to 31/05/2025 Reference Number: EMA/67201/2025 Summary:

This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of patients with acute respiratory distress syndrome (EMEA/CPMP/EWP/504/97 Rev.1).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome

Draft: consultation closed Consultation dates: 04/05/2023 to 31/07/2023 Reference Number: EMA/CHMP/175067/2023

Document history - Revision 1

Guideline on clinical investigation of medicinal products in the treatment of patients with Acute Respiratory Distress Syndrome - Revision 1

Adopted Reference Number: EMEA/CPMP/EWP/504/97 Rev 1 Legal effective date: 01/04/2007

Overview of comments received on draft guideline on clinical investigation of medicinal products in prevention and treatment of Acute Respiratory Distress Syndrome

Reference Number: CHMP/EWP/358390/2006