Title |
Barriers to the conduct of randomised clinical trials within all disease areas
|
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Published in |
Trials, August 2017
|
DOI | 10.1186/s13063-017-2099-9 |
Pubmed ID | |
Authors |
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 |
Abstract |
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. 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. 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 11 | 26% |
Canada | 3 | 7% |
Germany | 2 | 5% |
China | 2 | 5% |
Italy | 2 | 5% |
Poland | 1 | 2% |
Switzerland | 1 | 2% |
Spain | 1 | 2% |
Mexico | 1 | 2% |
Other | 3 | 7% |
Unknown | 16 | 37% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 25 | 58% |
Scientists | 15 | 35% |
Practitioners (doctors, other healthcare professionals) | 2 | 5% |
Science communicators (journalists, bloggers, editors) | 1 | 2% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 184 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 25 | 14% |
Researcher | 23 | 13% |
Student > Ph. D. Student | 19 | 10% |
Student > Bachelor | 19 | 10% |
Other | 11 | 6% |
Other | 33 | 18% |
Unknown | 54 | 29% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 50 | 27% |
Nursing and Health Professions | 23 | 13% |
Pharmacology, Toxicology and Pharmaceutical Science | 15 | 8% |
Biochemistry, Genetics and Molecular Biology | 8 | 4% |
Social Sciences | 5 | 3% |
Other | 23 | 13% |
Unknown | 60 | 33% |