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.
Subject(s)
Multicenter Studies as Topic/methods , Pragmatic Clinical Trials as Topic/methods , Randomized Controlled Trials as Topic/methods , Research Design , Attitude of Health Personnel , Confidentiality , Cooperative Behavior , Equipment and Supplies , Europe , Evidence-Based Medicine , Health Knowledge, Attitudes, Practice , Humans , Multicenter Studies as Topic/economics , Multicenter Studies as Topic/legislation & jurisprudence , Nutrition Therapy , Pragmatic Clinical Trials as Topic/economics , Pragmatic Clinical Trials as Topic/legislation & jurisprudence , Randomized Controlled Trials as Topic/economics , Randomized Controlled Trials as Topic/legislation & jurisprudence , Rare Diseases/therapy , Research Design/legislation & jurisprudence , Research Personnel , Research Support as TopicABSTRACT
While scholarship on health in conflict-affected countries is growing, there has been relatively little analysis of how armed conflict affects health systems in specific African countries, especially former French colonies. There is even less literature on the role of history in shaping health systems and how historical factors such as inequity may influence health impacts of armed conflict. Based on Côte d'Ivoire, this article argues that historical multidisciplinary analysis can provide valuable insight into the macro-level political, economic and social determinants of the health system over time. It explores how armed conflict has affected health services and exacerbates historically inherited challenges to the health system including unequal distribution of health services, bias towards curative care in urban areas, inadequate human resources and weak health governance. In the post-conflict period, this understanding may assist governments and other stakeholders to develop more appropriate health policies that address both urgent and long-term health needs.
