Barriers to the conduct of randomised clinical trials within all disease areas.
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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.
SUBMITTER: Djurisic S
PROVIDER: S-EPMC5539637 | biostudies-literature | 2017 Aug
REPOSITORIES: biostudies-literature
Publications
Barriers to the conduct of randomised clinical trials within all disease areas.
Djurisic Snezana S Rath Ana A Gaber Sabrina S Garattini Silvio S Bertele Vittorio V Ngwabyt Sandra-Nadia SN Hivert Virginie V Neugebauer Edmund A M EAM Laville Martine M Hiesmayr Michael M Demotes-Mainard Jacques J Kubiak Christine C Jakobsen Janus C JC Gluud Christian C
Trials 20170801 1
<h4>Background</h4>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.<h4>Methods</h4>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. ...[more]
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