Real-World Evidence: US FDA's Prucalopride Review Shows Datasets' Utility And Limitations

Both the advantages and disadvantages in using existing real-world datasets in the regulatory setting were highlighted by the US FDA advisory committee review of Shire PLC’s constipation drug, Motegrity (prucalopride). Explore the controversy surrounding this review and the implications of how regulatory decision making is being challenged with the use of real-world drug efficacy and safety evidence in this comprehensive article, which also inspects the study’s use of European postmarketing experience and the explores question of whether the study’s databases could be used to mine information about cancer and suicide risks associated with the drug.