1. Barriers to the conduct of randomised clinical trials within all disease areas.
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Djurisic, Snezana, Rath, Ana, Gaber, Sabrina, Garattini, Silvio, Bertele, Vittorio, Ngwabyt, Sandra-Nadia, Hivert, Virginie, Neugebauer, Edmund A. M., Laville, Martine, Hiesmayr, Michael, Demotes-Mainard, Jacques, Kubiak, Christine, Jakobsen, Janus C., and Gluud, Christian
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RANDOMIZED controlled trials , *CLINICAL medicine research , *MEDICAL research , *RESEARCH methodology , *INTERNATIONAL cooperation , *RESEARCH laws , *CLINICAL trial laws , *SYMPTOMS , *ATTITUDE (Psychology) , *CLINICAL trials , *COOPERATIVENESS , *DIET therapy , *ENDOWMENT of research , *EXPERIMENTAL design , *HEALTH attitudes , *MEDICAL cooperation , *MEDICAL ethics , *MEDICAL personnel , *PRIVACY , *RESEARCH , *SYSTEMATIC reviews , *EVIDENCE-based medicine , *EQUIPMENT & supplies , *RESEARCH personnel , *ECONOMICS , *THERAPEUTICS , *MEDICAL laws ,RESEARCH & economics - 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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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