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Barriers for conducting clinical trials in developing countries- a systematic review
Chalachew Alemayehu1, Geoffrey Mitchell2, Jane Nikles3
1Faculty of Medicine University of Queensland, Brisbane, Australia. bestchale@yahoo.com.
Clinical researchers in developing countries face significant barriers to conducting clinical trials, including limited resources and regulatory hurdles. Implementing local investigator-initiated trials can improve health equity by addressing country-specific needs.
Area of Science:
- Global Health
- Clinical Research
- Health Equity
Background:
- Developing countries face a high burden of communicable and non-communicable diseases.
- Under-representation in global clinical trials perpetuates health inequities.
- Barriers hinder clinical researchers in developing nations.
Purpose of the Study:
- To review literature on barriers faced by clinical researchers in developing countries.
- To identify key obstacles to conducting clinical trials in these regions.
Main Methods:
- Comprehensive literature search of major databases (PubMed, Embase, CINAHL, Web of Science, WHO Global Health Library).
- Inclusion of grey literature.
- Appraisal of relevant articles by two independent reviewers.
Main Results:
- Ten studies, reported in 15 papers, were included.
- Five major themes of barriers were identified: financial and human capacity limitations, ethical/regulatory obstacles, lack of research environment, operational challenges, and competing demands.
- Barriers exist at system, organizational, and individual levels.
Conclusions:
- Addressing barriers requires systemic changes.
- Recommends wider implementation of local investigator-initiated trials.
- Local trials are more responsive to national needs and build on local healthcare knowledge.
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