Open for consultation from 12 December to 12 April, this draft ICH guideline sets out how to design and submit robust patient preference studies to inform regulatory decision‑making across a medicine’s lifecycle.
From shared standards to local impact, the 2nd Clinical Research Networks Conference agreed concrete next steps for interoperable clinical research networks worldwide
New EMA ICH M14 guidelines sets common international standards for non‑interventional real‑world data studies to strengthen medicine safety assessment.
A new simulation framework leverages pharmacometrics to optimise clinical trial designs for disease-modifying treatments in rare neurological conditions.
Experts provide a comprehensive reflection on the unique clinical and methodological challenges inherent in designing and executing trials for rare diseases.
