Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Clinical Trials Regulations (CTR) – An analysis of the first clinical trial applications in the public portal of the Clinical Trials Information System (CTIS) ***

Katharina Böhm (Abschlußjahr: 2023)

Summary
Language: English
In January 2022, the Regulation (EU) No 536/2014, known as the "Clinical Trials Regulation" (CTR), became applicable within the European Union (EU), replacing the former legal basis for clinical trials, the Directive 2001/20/EC, known as the "Clinical Trial Directive". The CTR introduced significant changes to the regulatory environment for clinical trials in the EU and the European Economic Area (EEA), including the implementation of a single-entry point for clinical trial applications through the "Clinical Trials Information System" (CTIS). All information about clinical trials and all communication between stakeholders will be handled via CTIS for clinical trials under the legal framework of the CTR. One part of CTIS is a public portal, a publicly accessible website, which goes along with the aim of the CTR to increase transparency about clinical trials within the EU/EEA to the public.
For this master thesis, all initial clinical trial applications which were published in the public CTIS portal by the end of July 2023 were systematically analyzed to gain insights about the outcomes and timelines of the first initial clinical trial applications under the legal framework of the CTR. Relevant information was extracted from the public CTIS portal, compiled into a database, and analyzed subsequently.
One key finding of the analysis was that reasons for non-authorization of applications were not published in the public CTIS portal, which limits the transparency that was actually intended by the CTR. Additionally, non-compliance with CTR specifications regarding approvals with conditions was observed, with some of the conditions issued not meeting the requirement of the CTR that they could not be fulfilled by the time of authorization. Technical problems in the handling of CTIS, which have been reported by various stakeholders before, were also evident in the public CTIS portal.
Another key finding from the analysis was that the maximum duration of the individual authorization process steps for initial clinical trial applications, which include validation, Part I and Part II assessments, as well as the final decision, was frequently exceeded beyond the maximum timelines set by the CTR. Furthermore, the average duration for Part II assessment for initial clinical trial applications for multinational trials also went over the specified maximum timelines. Consequently, the average duration from submission to decision took longer than expected for multinational initial clinical trial applications in a few cases. These deviations from the given timelines are unexpected since CTIS was expected to follow strict evaluation rules and to allow no deviations from the set timelines.
At the time of the data cut off for the analysis, only 28% of the initial clinical trial applications with a decision under the CTR had been published in the public CTIS portal. As a result of this limited availability, there was an overrepresentation of initial clinical trial applications for mononational, non-commercial trials in the analysis. Despite the limitations of the analysis, it provides an extensive picture of the outcomes and timelines of initial clinical trial applications in the public CTIS portal 1.5 years after its implementation. Regular updates of the systematic analysis can provide further insights about initial clinical trial applications under the legal framework of the CTR as more clinical trials are published in the public CTIS portal and more information will be available in the future.
Pages: 54
Annexes: 2, Pages: 2