<p>The European Medicines Agency Clinical Data Website Enables Insights Into Clinical Development Timelines And Strategy</p>

Abstract

Purpose: The clinical study report (CSR) documents of a full clinical development pathway (CDP) have been publicly available on the European Medicines Agency (EMA; Amsterdam, Netherlands) clinical data website (ECDW) since October 2016. Our analysis aimed to determine the extent to which the available clinical development program could be assessed. Methods: The documents available on the ECDW up to April 1, 2018 and the corresponding European Public Assessment Report (EPAR) were reviewed. Information extracted from the available CSRs focused on dates, phase of development, module leaf structure, and number of protocol amendments. Data analyses included generalized activity normalization time table (GANTT) charts and network analyses. Results: Of the 86 available CDPs, 55 were initial marketing authorizations covering a diverse range of clinical developments from generics to advanced therapy in the electronic common technical documents (eCTDs). Non-redacted dates were available in 444 CSRs from 15 CDPs to perform retrospective project clinical development management analyses. In these 15 marketing authorizations, the median timespan to submission was 9.3 years (range: 6.2-22.2). The timespan within these 15 clinical developments ranged from 5.9 to 21.4 years (median 8.3). The median time to first-subject-in in the first controlled clinical study pertinent to the claimed indication (CCSPCI) was 4.4 years (range: 0-12.1); the duration of the CCSPCI ranged from 2.4 to 16.9 years (median: 4.4; interquartile range: 4.2-7.0). Four CDPs had concurrent subject enrolment, while seven CDPs had seamless study designs. Subject participation ranged from 52% to 97% of a clinical development timeline. Conclusion: The publication of CSR documents by the EMA has enabled insights into timelines and project management aspects of the clinical development of medications.