Dataset Information

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

ABSTRACT:

Background

Clinical 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.

Methods

Literature 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.

Results

Ten 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 recommendation

There 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.

SUBMITTER: Alemayehu C

PROVIDER: S-EPMC5863824 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Alemayehu Chalachew C Mitchell Geoffrey G Nikles Jane J

International journal for equity in health 20180322 1

<h4>Background</h4>Clinical 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 researc ...[more]

PMID: 29566721

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Project description:ImportanceA systematic assessment of existing research should justify the conduct and inform the design of new clinical research but is often lacking. There is little research on the barriers to and factors facilitating systematic evidence assessments.ObjectiveTo examine the practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials.Design, setting, and participantsIn this qualitative study, individual semistructured qualitative interviews were conducted between February and August 2020 with 48 Swiss stakeholder groups (27 primary investigators, 9 funders and sponsors, 6 clinical trial support organizations, and 6 ethics committee members) and between January and March 2021 with 9 international funders of clinical trials from North America and Europe with a reputation for requiring systematic evidence synthesis in applications for academic clinical trials.Main outcomes and measuresThe main outcomes were practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. Interviews were analyzed using conventional content analysis.ResultsOf the 57 participants, 40 (70.2%) were male. Participants universally acknowledged that a comprehensive understanding of the previous evidence is important but reported wide variation regarding how this should be achieved. Participants reported that the conduct of formal systematic reviews was currently not expected before most clinical trials, but most international funders reported expecting a systematic search for the existing evidence. Whereas time and resources were reported by all participants as barriers to conducting systematic reviews, the Swiss research ecosystem was reported not to be as supportive of a systematic approach compared with international settings.Conclusions and relevanceIn this qualitative study, Swiss stakeholders and international funders generally agreed that new clinical trials should be justified by a systematic evidence assessment but that barriers on individual, organizational, and political levels kept them from implementing it. More explicit requirements from funders appear to be needed to clarify the required level of comprehensiveness in summarizing existing evidence for different types of clinical trials.

Project description:BackgroundN-of-1 trials have a potential role in promoting patient-centered medicine in developing countries. However, there is limited academic literature regarding the use of N-of-1 trials in the clinical care of patients in resource-poor settings.ObjectiveTo assess the extent of use, purpose and treatment outcome of N-of-1 trials in developing countries.MethodA systematic review of clinical N-of-1 trials was conducted between 1985 and September 2015 using PubMed, Embase, CINAHL, Web of Science and the Cochrane Central Register of Controlled Trials. Grey literature databases and clinical trial registers were also searched. This review included randomized, multi-cycle, crossover within individual patient trials involving drug intervention. Quality assessment and data extraction were conducted by two independent reviewers.ResultOut of 131 N-of-1 trials identified, only 6 (4.5%) were conducted in developing countries. The major reason that N-of-1 trials were used was to provide evidence on feasibility, effectiveness and safety of therapies. A total of 72 participants were involved in these trials. Five of the studies were conducted in China and all evaluated Chinese traditional medicine. The remaining study was conducted in Brazil. The completion rate was 93%. More than half, 46 (69%) of subjects made medication changes consistent with trial results after trial completion. A number of threats to the validity of the included evidence limited the validity of the evidence. In particular, the estimated overall effect in four of the included studies could have been affected by the "carry over" of the previous treatment effect as no adequate pharmacokinetic evidence regarding traditional medicines was presented.ConclusionThe prevalence and scope of N-of-1 trials in developing countries is low. A coordinated effort among government, clinicians, researchers and sponsor organizations is needed to increase their uptake and quality in developing countries.Systematic review registrationPROSPERO CRD42015026841 .

Project description:BackgroundThe use of mobile health (mHealth) technologies to improve population-level health outcomes around the world has surged in the last decade. Research supports the use of mHealth apps to improve health outcomes such as maternal and infant mortality, treatment adherence, immunization rates, and prevention of communicable diseases. However, developing countries face significant barriers to successfully implement, sustain, and expand mHealth initiatives to improve the health of vulnerable populations.ObjectiveWe aimed to identify and synthesize barriers to the use of mHealth technologies such as text messaging (short message service [SMS]), calls, and apps to change and, where possible, improve the health behaviors and health outcomes of populations in developing countries.MethodsWe followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Deriving search criteria from the review's primary objective, we searched PubMed and CINAHL using an exhaustive terms search (eg, mHealth, text messaging, and developing countries, with their respective Medical Subject Headings) limited by publication date, English language, and full text. At least two authors thoroughly reviewed each article's abstract to verify the articles were germane to our objective. We then applied filters and conducted consensus meetings to confirm that the articles met the study criteria.ResultsReview of 2224 studies resulted in a final group of 30 articles for analysis. mHealth initiatives were used extensively worldwide for applications such as maternal health, prenatal care, infant care, HIV/AIDS prevention, treatment adherence, cardiovascular disease, diabetes, and health education. Studies were conducted in several developing countries in Africa, Asia, and Latin America. From each article, we recorded the specific health outcome that was improved, mHealth technology used, and barriers to the successful implementation of the intervention in a developing country. The most prominent health outcomes improved with mHealth were infectious diseases and maternal health, accounting for a combined 20/30 (67%) of the total studies in the analysis. The most frequent mHealth technology used was SMS, accounting for 18/30 (60%) of the studies. We identified 73 individual barriers and grouped them into 14 main categories. The top 3 barrier categories were infrastructure, lack of equipment, and technology gap, which together accounted for 28 individual barriers.ConclusionsThis systematic review shed light on the most prominent health outcomes that can be improved using mHealth technology interventions in developing countries. The barriers identified will provide leaders of future intervention projects a solid foundation for their design, thus increasing the chances for long-term success. We suggest that, to overcome the top three barriers, project leaders who wish to implement mHealth interventions must establish partnerships with local governments and nongovernmental organizations to secure funding, leadership, and the required infrastructure.

Project description:BackgroundThe present review aimed to systematically identify and classify barriers and facilitators of conducting research with a team science approach.MethodsPubMed, EMBASE, PsycINFO, Scopus, Web of Science, Emerald, and ProQuest databases were searched for primary research studies conducted using quantitative, qualitative, or mixed methods. Studies examining barriers and facilitators of research with a team science approach were included in search. Two independent reviewers screened the texts, extracted and coded the data. Quality assessment was performed for all 35 included articles. The identified barriers and facilitators were categorized within Human, Organization, and Technology model.ResultsA total of 35 studies from 9,381 articles met the inclusion criteria, from which 42 barriers and 148 facilitators were identified. Human barriers were characteristics of the researchers, teaming skills, and time. We consider Human facilitators across nine sub-themes as follows: characteristics of the researchers, roles, goals, communication, trust, conflict, disciplinary distances, academic rank, and collaboration experience. The barriers related to organization were institutional policies, team science integration, and funding. Organizational facilitators were as follows: team science skills training, institutional policies, and evaluation. Facilitators in the field of technology included virtual readiness and data management, and the technology barriers were complexity of techniques and privacy issues.ConclusionsWe identified major barriers and facilitators for conducting research with team science approach. The findings have important connotations for ongoing and future implementation of this intervention strategy in research. The analysis of this review provides evidence to inform policy-makers, funding providers, researchers, and students on the existing barriers and facilitators of team science research.Trial registrationThis review was prospectively registered on PROSPERO database (PROSPERO 2021 CRD42021278704).

Project description:ObjectivesTo update the current evidence base on paediatric postdischarge mortality (PDM) in developing countries. Secondary objectives included an evaluation of risk factors, timing and location of PDM.DesignSystematic literature review without meta-analysis.Data sourcesSearches of Medline and EMBASE were conducted from October 2012 to July 2017.Eligibility criteriaStudies were included if they were conducted in developing countries and examined paediatric PDM. 1238 articles were screened, yielding 11 eligible studies. These were added to 13 studies identified in a previous systematic review including studies prior to October 2012. In total, 24 studies were included for analysis.Data extraction and synthesisTwo independent reviewers extracted and synthesised data using Microsoft Excel.ResultsStudies were conducted mostly within African countries (19 of 24) and looked at all admissions or specific subsets of admissions. The primary subpopulations included malnutrition, respiratory infections, diarrhoeal diseases, malaria and anaemia. The anaemia and malaria subpopulations had the lowest PDM rates (typically 1%-2%), while those with malnutrition and respiratory infections had the highest (typically 3%-20%). Although there was significant heterogeneity between study populations and follow-up periods, studies consistently found rates of PDM to be similar, or to exceed, in-hospital mortality. Furthermore, over two-thirds of deaths after discharge occurred at home. Highly significant risk factors for PDM across all infectious admissions included HIV status, young age, pneumonia, malnutrition, anthropometric variables, hypoxia, anaemia, leaving hospital against medical advice and previous hospitalisations.ConclusionsPostdischarge mortality rates are often as high as in-hospital mortality, yet remain largely unaddressed. Most children who die following discharge do so at home, suggesting that interventions applied prior to discharge are ideal to addressing this neglected cause of mortality. The development, therefore, of evidence-based, risk-guided, interventions must be a focus to achieve the sustainable development goals.

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Dataset Information

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

Background

Methods

Results

Conclusion and recommendation

Publications

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

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