Skip to Main content Skip to Navigation
Journal articles

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

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.
Document type :
Journal articles
Complete list of metadata

Cited literature [68 references]  Display  Hide  Download
Contributor : BMC BMC Connect in order to contact the contributor
Submitted on : Sunday, August 6, 2017 - 5:34:53 AM
Last modification on : Thursday, September 23, 2021 - 3:21:41 AM


Publisher files allowed on an open archive




Snezana Djurisic, Ana Rath, Sabrina Gaber, Silvio Garattini, Vittorio Bertele, et al.. Barriers to the conduct of randomised clinical trials within all disease areas. Trials, BioMed Central, 2017, 18 (1), pp.360. ⟨10.1186/s13063-017-2099-9⟩. ⟨inserm-01572262⟩



Record views


Files downloads