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Published in: Trials 1/2017

Open Access 01-12-2017 | Review

Barriers to the conduct of randomised clinical trials within all disease areas

Authors: Snezana Djurisic, Ana Rath, Sabrina Gaber, Silvio Garattini, Vittorio Bertele, Sandra-Nadia Ngwabyt, Virginie Hivert, Edmund A. M. Neugebauer, Martine Laville, Michael Hiesmayr, Jacques Demotes-Mainard, Christine Kubiak, Janus C. Jakobsen, Christian Gluud

Published in: Trials | Issue 1/2017

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Abstract

Background

Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.

Methods

We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.

Results

The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.

Conclusions

The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area.
Appendix
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Footnotes
1
Funded by the European Union Framework Programme 7 (EU FP7; grant agreement no. 284395), ECRIN-IA involved 23 countries and brought together diverse stakeholders to overcome barriers to clinical research in three particularly difficult areas (rare diseases, medical devices, and nutrition). Specifically, the project aimed to develop tools, services, and infrastructure to facilitate multinational clinical research in Europe, and to support the development of pan-European disease networks to drive clinical projects [7, 81]. This in turn was intended to improve Europe’s attractiveness to industry, boost its scientific competitiveness, and result in better healthcare for European citizens. Originally planned for 4 years (2012–2015), the clinical trials work package was extended until 2017 [7, 81, 76].
 
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Metadata
Title
Barriers to the conduct of randomised clinical trials within all disease areas
Authors
Snezana Djurisic
Ana Rath
Sabrina Gaber
Silvio Garattini
Vittorio Bertele
Sandra-Nadia Ngwabyt
Virginie Hivert
Edmund A. M. Neugebauer
Martine Laville
Michael Hiesmayr
Jacques Demotes-Mainard
Christine Kubiak
Janus C. Jakobsen
Christian Gluud
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2099-9

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