PHP194 - THE EMA CLINICAL DATA WEBSITE: A CONCEPTUAL EXPLORATORY APPROACH TO BENCHMARK CLINICAL DEVELOPMENT INDICATORS IN MARKETING AUTHORIZATIONS

Abstract

The European Medicines Agency (EMA) policy on clinical data publication entered into force on 1 January 2015. Data have been regularly uploaded and are accessible to the public on the EMA Website. For the first time clinical study reports of the full clinical development have been made available. The aim of this study is to give an overview on the number and types of trials published and to analyze clinical development pathways. All available initial marketing applications on the EMA Clinical Data Website up to 1 April 2018 were analyzed. A total of 3974 documents on the website were manually reviewed by application category and analyzed iteratively. Data extraction was time-consuming. From 86 dossiers published, 55 Initial Marketing Authorizations (IMA) were available from 37 applicants for 48 indications. The 55 IMA were categorized into 17 generic, 3 biosimilar, 10 orphan and 25 other applications, by the EMA. In total 610 study reports were available, 348 phase I, 81 phase II, 124 phase III, 15 phase IV and 42 clinical studies without a designated phase. Not all studies were available, e.g. fixed-dose combination IMA did not necessarily contain all studies from individual substance development pathways. The median time from first subject-in (FSI) in the first phase I to the FSI in phase II was found to be 24 months (Interquartile range [IQR]: 9, 38) for 19 IMA. The median time from FSI in the first phase I to the FSI in phase III was found to be 55 months (IQR: 30, 62). The availability of clinical study reports and appendices, e.g. protocol, permit an insight into the strategic decision making process of clinical trial development pathways. Phase I study reports constitute a considerable percentage of the studies. Phase III studies started in the latter half of the development pathway.