Legal Requirements, Definitions, and Standards for Non-interventional Drug Studies: A Global Picture of Variability-Results and Conclusions From a Single-Institution Survey.

Abstract

Non-interventional studies (NIS) have become increasingly important in the continuous benefit-risk assessment of medicines. However, the diversity in study designs and in requirements necessitates a careful planning of NIS. In view of a changing regulatory environment, a company-internal online survey was initiated to gather information on existing standards, definitions, and requirements for NIS and to draw advice for the future conduct of multinational NIS. Answers from 45 countries worldwide depicted a global picture of variability in terms of legal and regulatory requirements for NIS. Definitions and terminology are lacking harmonization, and different good practice standards are concurrently in use. Variations in terms of applicable standards and requirements were observed within most geographic regions. The methodological variety in terms of study designs and the divergent perspectives on NIS constitute communicative barriers. Because of the absence of one worldwide applicable good practice standard, differences in semantics and regulatory systems contribute to system disparities.