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Review
. 2017 Aug 1;18(1):360.
doi: 10.1186/s13063-017-2099-9.

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

Snezana Djurisic  1 , Ana Rath  2 , Sabrina Gaber  3 , Silvio Garattini  4 , Vittorio Bertele  4 , Sandra-Nadia Ngwabyt  2 , Virginie Hivert  5 , Edmund A M Neugebauer  6 , Martine Laville  7 , Michael Hiesmayr  8 , Jacques Demotes-Mainard  3 , Christine Kubiak  3 , Janus C Jakobsen  9   10 , Christian Gluud  11
Affiliations
Review

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

Snezana Djurisic et al. Trials. .

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.

Keywords: Barriers; Bottlenecks; Challenges; Evidence based clinical practice; Evidence based medicine; Hindrances; Randomised clinical trials.

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Competing interests

The authors have no competing interests to declare apart from their involvement in clinical trials as well as in ECRIN.

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Figures

Fig. 1
Fig. 1
Preferred reporting items for systematic reviews and meta-analyses (PRISMA) 2009 flow diagram, depicting the process for selection of relevant literature
See this image and copyright information in PMC

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