ICH Pharmacoepidemiological Study Guidance Out

FDA has published for public comment the International Council for Harmonization M14 guidance, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines. The document recommends international standards for, and promotes harmonization of, the general principles on planning, designing, and analyzing observational (non-interventional) pharmacoepidemiological studies that use fit-for-purpose data for safety assessment of medicines.

The guidance says it includes recommendations for studies using real-world data conducted to evaluate the post-marketing safety of medicinal products. “It is beyond the scope of this document to provide guidance on whether a clinical trial or a pharmacoepidemiological study is the most appropriate approach,” it says, “nor is it intended as a comprehensive source of knowledge for pharmacoepidemiological methods.”