Abstract
BackgroundClinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe.MethodsA survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action.ResultsMost scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know‐how and documents. Since harmonization was mainly a bottom‐up approach up until now, the extent and topics dealt with are diverse and there is only little cross‐networking and cross‐country exchange so far.ConclusionsCurrently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.
Highlights
Clinical trials remain key to the development of evidence-based medical practice
Multinational clinical trials are significantly more complex to perform than national ones due in particular to the difficulties arising from the diversity of legal frameworks and operational practices
The number of clinical trials, those initiated by academic investigators, has been falling in recent years in many regions, including the European Union (EU).[2]
Summary
Clinical trials remain key to the development of evidence-based medical practice. Over the years, there has been a growing trend to perform large-scale clinical trials across borders, in industry but in academic settings as well. It aims, among other things, to improve collaboration, information-sharing, and decision-making between and within Member States.[3] The Heads of Medicines Agencies (HMA) established the Clinical Trials Facilitation Group (CTFG) in order to harmonize activities across Member States.[4] To ease the implementation of the CTR, pilot projects have begun at national level in some countries. The term “research infrastructure” is used here to mean an organization that provides facilities, resources, or related services to researchers to enable toplevel scientific research; in the particular context of this article, we refer to “infrastructures” that support multinational clinical research in Europe We believe that these types of infrastructures, as well as existing harmonization processes (at national level), may be relevant for the implementation of the CTR (and beyond). To identify new fields of action for ECRIN to increase the quality and efficiency of multinational clinical research
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
