Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparative analysis of the strategies for implementation of the Clinical Trials Regulation (EU) No 536/2014 in Europe ***

Dr. Nicole Woik (Abschlußjahr: 2019)

Summary
Language: English
The Clinical Trials Regulation 536/2014 (CTR) of the European Commission, the European Parliament and the European Council on clinical trials with medicinal products for human use will change the clinical trial authorisation procedure in many ways. The current European authorisation procedures for clinical trials run on an independent national level and differ between the member states. Once implemented, the CTR is going to uniform the assessment and decision making procedure, shorten the timelines, and harmonize the regulatory conditions for all interventional clinical trials in the EU. The member states are well advised to in advance adapt their national legislation and to implement a national system that allows for the coordinated assessment within the tight CTR timelines. This thesis aims to comparatively analyse the current activities to prepare for the CTR.
The thesis shows that the EU in general is well prepared. Most of the member states did implement the CTR into their legislation. Many member states decided and started the reorganisation of their current structure to be able to fulfil the conditions under the CTR. This reorganisation mainly affects the ethics part. Strategies include the reduction of ethics committees, the elimination of local ethics committees and the establishment of coordinating instruments.
In parallel the CTFG and some EU member states implement pilots to test the strategies for their suitability and learn about best practices for joint European and national assessment. However, since the approval of clinical trials is currently still subject to the legal requirements of the Clinical Trials Directive 2001/20/EC (CTD), implemented unequally amongst the member states, these pilots are not trivial in their planning, implementation and evaluation.
Current pilots can be categorized in the VHP, the VHP+, the National and the Multinational Pilot. The last is composed of the VHP+ Pilot and the Joint Pilot. Their establishment is strongly dependent on national factors. VHP+ is an enhancement of the proven VHP and involves the ethics committees. VHP and VHP+ are mimicking the Europe-wide joint decision on part I while the National Pilot simulates national part I and II assessment within the tight CTR deadlines and reflects the needs and focus of the respective member state. Experience with the Multinational pilot is only starting now. The principle of the Joint Pilot is closest to the CTR while the member states that are currently best mimicking CTR follow the VHP+ Pilot.    
Reliable systems are provided by the national competent authorities to familiarize with the CTR procedures at an early stage. Also applicants are well advised to change their systems and to observe the national adjustments. Indeed, pilot projects are used with high frequency. In principle, it is as important for the applicant to test National Pilots as to participate in the VHP/VHP+ as the procedures have a different focus. In addition, a single clinical trial is not suitable for each type of pilot. The pilot selection depends on the features of the clinical trial to be submitted.  
The Pilots Categories do not target all action points of the CTR and differ in scope. Complex clinical trials can be submitted but are challenging. They might become a hot topic in the future. The safety reporting in clinical trials is not covered by any of the Pilot Categories but by a separate procedure established by the CTFG and SUKL. However, in 2019 the reference safety information (RSI) is still among the critical points in the evaluation of clinical trials. Other critical points are the contracts and the trainings. Finally, there are clinical trial types that are not targeted by the CTR but share the same need for discussion and harmonization. Accordingly, the CTR might be the beginning of a sequence of changes.
Pages: 71
Annexes: 1, Pages: 5