Barriers for conducting clinical trials in developing countries- a systematic review

Abstract

BackgroundClinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries.MethodsLiterature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers.ResultsTen studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands.Conclusion and recommendationThere were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda.Electronic supplementary materialThe online version of this article (10.1186/s12939-018-0748-6) contains supplementary material, which is available to authorized users.

The harsh world of publishing in emerging regions and implications for editors and publishers: The case of Vietnam

“…The underrepresentation of research from the developing world results in a bias toward the developed world's research agenda, as well as an uneven adoption of new scientific practices in the former (Gwynn, ). This situation is notably alarming in the field of healthcare and medicine (Alemayehu, Mitchell, & Nikles, ; Ali et al ., ; Cash‐Gibson et al ., ). More importantly, when excluding the research output from emerging powers such as Brazil, Russia, India, China, and South Africa – known as the BRICS countries – over the past decade, scientific publications from many developing countries remain minuscule in comparison.…”

A Capacity-building Pilot Program to Increase Critical Care Research Productivity in the Middle East Region

“…In this report, we describe a clinical research training program that aimed to increase the research knowledge and skills as well as research productivity among critical care clinicians in the Middle East region. The program addressed three major factors that contribute to low research productivity in developing countries which include: lack of research knowledge and skills, lack of mentorship, and poor preparation of manuscripts [4,5]. This was a pilot program and therefore included a relatively small number of participants.…”

“…Several factors contribute to this low research productivity which include lack of training in clinical research resulting in poor research skills, de ciency of local mentors, minimal nancial resources, as well as lack of language pro ciency and suboptimal writing skills being obstacles to publication in peerreviewed journals [4,5].…”

A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries

“…However, these countries could also offer an attractive setting for clinical trials [8]. Conducting clinical trials in sub-Sahara Africa promotes access to innovative medical countermeasures and enhances the research capacities of scientists in these countries [9]. Importantly, clinical trials need to be responsive to the needs of host communities.…”