A 1-year cross-sectional analysis of non-interventional post-marketing study protocols submitted to the German Federal Institute for Drugs and Medical Devices (BfArM)

摘要

PurposeThe aim of non-interventional studies (NIS) with medicinal products is to investigate the use of authorized medicinal products in daily routine. In the past, this type of study has been subject to frequent criticism, and many recommendations have been published. The aim of our study was to assess the quality of NIS study protocols.