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

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

doi:10.1186/s13063-017-2099-9

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

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

Copenhagen Trial Unit Rigshospitalet

134 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	18
Udgave nummer	1
Sider (fra-til)	360
ISSN	1745-6215
DOI	https://doi.org/10.1186/s13063-017-2099-9
Status	Udgivet - 1 aug. 2017

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10.1186/s13063-017-2099-9

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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.",

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author = "Snezana Djurisic and Ana Rath and Sabrina Gaber and Silvio Garattini and Vittorio Bertele' and Sandra-Nadia Ngwabyt and Virginie Hivert and Neugebauer, {Edmund A M} and Martine Laville and Michael Hiesmayr and Jacques Demotes-Mainard and Christine Kubiak and Jakobsen, {Janus C} and Christian Gluud",

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T1 - Barriers to the conduct of randomised clinical trials within all disease areas

AU - Djurisic, Snezana

AU - Rath, Ana

AU - Gaber, Sabrina

AU - Garattini, Silvio

AU - Bertele', Vittorio

AU - Ngwabyt, Sandra-Nadia

AU - Hivert, Virginie

AU - Neugebauer, Edmund A M

AU - Laville, Martine

AU - Hiesmayr, Michael

AU - Demotes-Mainard, Jacques

AU - Kubiak, Christine

AU - Jakobsen, Janus C

AU - Gluud, Christian

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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.

AB - 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.

KW - Journal Article

KW - Review

U2 - 10.1186/s13063-017-2099-9

DO - 10.1186/s13063-017-2099-9

M3 - Journal article

C2 - 28764809

SN - 1745-6215

VL - 18

SP - 360

JO - Trials

JF - Trials

IS - 1

ER -

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

Abstract

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