scholarly journals Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017246 ◽  
Author(s):  
Samuel R P Franzen ◽  
Clare Chandler ◽  
Sisira Siribaddana ◽  
Julius Atashili ◽  
Brian Angus ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Necessary Conditions ◽  
Evidence Based ◽  
Middle Income ◽  
Trial Conduct ◽  
Middle Income Countries ◽  
Barriers And Enablers ◽  
Research Systems ◽  
Clinical Trial Conduct

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

scholarly journals Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Jalemba Aluvaala ◽  
Lucy Bradshaw ◽  
Jane P Daniels ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Global Health ◽  
Good Clinical Practice ◽  
Research Experience ◽  
Middle Income ◽  
Middle Income Countries ◽  
Training Package

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

scholarly journals Conducting clinical trials during the COVID-19 pandemic—a collaborative trial network response

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura Robison ◽  
◽  
Yeoungjee Cho ◽  
Andrea K. Viecelli ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Group ◽  
Collaborative Research ◽  
Healthcare Systems ◽  
Care Community ◽  
Contingency Plan ◽  
Trial Conduct ◽  
Trial Network ◽  
Clinical Trial Conduct

AbstractThe unprecedented demand placed on healthcare systems from the COVID-19 pandemic has forced a reassessment of clinical trial conduct and feasibility. Consequently, the Australasian Kidney Trials Network (AKTN), an established collaborative research group known for conducting investigator-initiated global clinical trials, had to efficiently respond and adapt to the changing landscape during COVID-19. Key priorities included ensuring patient and staff safety, trial integrity and network sustainability for the kidney care community. New resources have been developed to enable a structured review and contingency plan of trial activities during the pandemic and beyond.

Analysis of Registered Clinical Trials in The WHO International Clinical Trials Registry Platform, 2005-2019: A Cross-section Study (Preprint)

2020 ◽  
Author(s):  
Fei Zhao ◽  
Wei Xue ◽  
Wenyuan Qi ◽  
Duanduan Cong ◽  
Huiqing Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Middle Income ◽  
Middle Income Countries ◽  
Increasing Trend ◽  
Clinical Trials Registry ◽  
Over Time ◽  
Trial Performance

BACKGROUND Background: World health organization and the international committee of medical journal editors call for clinical trial registration before the start of the recruitment of participants. The registration promotes transparency and accessibility to all researchers and targeted patients globally. OBJECTIVE Objective: We conducted this research to explore the tendency and change of clinical trial registration among different classifications, in order to show the development of the registered clinical trials in the world. METHODS Methods: All clinical trials which had registered in the database of the International Clinical Trials Registry Platform (ICTRP) from 2005 to 2019 were collected as the database for analysis in this study. Developments of clinical trial registration were analyzed in terms of different registries, different regions, different income country classifications by covariance analysis for the difference in clinical trial registration and Cochran-Armitage Test for trend. The sample size enrolled was analyzed to explore whether there was any change in the scale of the clinical trials over time. RESULTS Results: Totally 205,228 clinical trials were registered in the ICTRP from 2005 to 2019. The numbers of clinical trial implementation annually increased as an exponential function (R2=0.83，t=10.45，P< .001). Almost 65% of clinical trials were performed in North American and East Asia & Pacific regions. There was a significant increasing trend in the numbers of clinical trial performance over time (F=184.85, P< .001). The numbers of clinical trial registration were different significantly between different income classifications of the country (F=90.84, P< .001). The sample sizes of the same Phases of clinical trials had no significant difference adjusted by income classification over time changes (F=0.57, P= .45). CONCLUSIONS Conclusions: The clinical trials were becoming flourishing in the world. Most of the clinical trials had performed in high and upper-middle-income countries, especially North American and East Asia & Pacific. And the lower-middle-income countries had a much faster-increasing trend in the clinical trial performance.

Health research capacity in Nepal: Analysis of the trend and the role of local researchers

2021 ◽  
pp. 004947552098277
Author(s):  
Madhu Kharel ◽  
Alpha Pokharel ◽  
Krishna P Sapkota ◽  
Prasant V Shahi ◽  
Pratisha Shakya ◽  
...  
Keyword(s):  
Health Research ◽  
Fold Increase ◽  
Research Capacity ◽  
Rapid Review ◽  
Evidence Based ◽  
Middle Income ◽  
Middle Income Countries ◽  
Health Related ◽  
Evidence Based Decision Making

Evidence-based decision-making is less common in low- and middle-income countries where the research capacity remains low. Nepal, a lower-middle-income country in Asia, is not an exception. We conducted a rapid review to identify the trend of health research in Nepal and found more than seven-fold increase in the number of published health-related articles between 2000 and 2018. The proportion of articles with Nepalese researchers as the first authors has also risen over the years, though they are still only in two-thirds of the articles in 2018.

scholarly journals Evidence-Based Guidelines for Mental, Neurological, and Substance Use Disorders in Low- and Middle-Income Countries: Summary of WHO Recommendations

PLoS Medicine ◽  
2011 ◽  
Vol 8 (11) ◽  
pp. e1001122 ◽  
Author(s):  
Tarun Dua ◽  
Corrado Barbui ◽  
Nicolas Clark ◽  
Alexandra Fleischmann ◽  
Vladimir Poznyak ◽  
...  
Keyword(s):  
Substance Use ◽  
Substance Use Disorders ◽  
Evidence Based ◽  
Middle Income ◽  
Middle Income Countries ◽  
Evidence Based Guidelines ◽  
Low And Middle Income

International Standards for Clinical Trial Conduct and Reporting

2003 ◽  
Vol 82 (6) ◽  
pp. 415-416 ◽  
Author(s):  
Richard Niederman ◽  
Derek Richards ◽  
Debora Matthews ◽  
Daniel Shugars ◽  
Helen Worthington ◽  
...  
Keyword(s):  
Clinical Trial ◽  
International Standards ◽  
Trial Conduct ◽  
Clinical Trial Conduct

scholarly journals Evidence-based interventions to reduce mortality among preterm and low-birthweight neonates in low-income and middle-income countries: a systematic review and meta-analysis

2021 ◽  
Vol 6 (2) ◽  
pp. e003618
Author(s):  
Mirjam Y Kleinhout ◽  
Merel M Stevens ◽  
Kwabena Aqyapong Osman ◽  
Kwame Adu-Bonsaffoh ◽  
Floris Groenendaal ◽  
...  
Keyword(s):  
Low Income ◽  
Low Birthweight ◽  
Meta Analysis ◽  
Neonatal Resuscitation ◽  
Newborn Care ◽  
Evidence Based ◽  
Antenatal Corticosteroids ◽  
Essential Newborn Care ◽  
Middle Income ◽  
Middle Income Countries

BackgroundPreterm birth is the leading cause of under-five-mortality worldwide, with the highest burden in low-income and middle-income countries (LMICs). The aim of this study was to synthesise evidence-based interventions for preterm and low birthweight (LBW) neonates in LMICs, their associated neonatal mortality rate (NMR), and barriers and facilitators to their implementation. This study updates all existing evidence on this topic and reviews evidence on interventions that have not been previously considered in current WHO recommendations.MethodsSix electronic databases were searched until 3 March 2020 for randomised controlled trials reporting NMR of preterm and/or LBW newborns following any intervention in LMICs. Risk ratios for mortality outcomes were pooled where appropriate using a random effects model (PROSPERO registration number: CRD42019139267).Results1236 studies were identified, of which 49 were narratively synthesised and 9 contributed to the meta-analysis. The studies included 39 interventions in 21 countries with 46 993 participants. High-quality evidence suggested significant reduction of NMR following antenatal corticosteroids (Pakistan risk ratio (RR) 0.89; 95% CI 0.80 to 0.99|Guatemala 0.74; 0.68 to 0.81), single cord (0.65; 0.50 to 0.86) and skin cleansing with chlorhexidine (0.72; 0.55 to 0.95), early BCG vaccine (0.64; 0.48 to 0.86; I2 0%), community kangaroo mother care (OR 0.73; 0.55 to 0.97; I2 0%) and home-based newborn care (preterm 0.25; 0.14 to 0.48|LBW 0.42; 0.27 to 0.65). No effects on perinatal (essential newborn care 1.02; 0.91 to 1.14|neonatal resuscitation 0.95; 0.84 to 1.07) or 7-day NMR (essential newborn care 1.03; 0.83 to 1.27|neonatal resuscitation 0.92; 0.77 to 1.09) were observed after training birth attendants.ConclusionThe findings of this study encourage the implementation of additional, evidence-based interventions in the current (WHO) guidelines and to be selective in usage of antenatal corticosteroids, to reduce mortality among preterm and LBW neonates in LMICs. Given the global commitment to end all preventable neonatal deaths by 2030, continuous evaluation and improvement of the current guidelines should be a priority on the agenda.

Abstract WP418: A Systematic Comparison of Key Features of Ischaemic Stroke Prevention Guidelines in Low- and Middle-income vs High-income Countries

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Hernan O Bayona ◽  
Mayowa Owolabi ◽  
Wayne Feng ◽  
James R Sawers ◽  
Paul Olowoyo ◽  
...  
Keyword(s):  
Stroke Prevention ◽  
High Income ◽  
Evidence Based ◽  
Vascular Risk ◽  
Eligibility Criteria ◽  
Middle Income ◽  
Middle Income Countries ◽  
Prevention Guideline ◽  
Prevention Guidelines ◽  
Low And Middle Income

Introduction: Implementation of contextually appropriate, evidence-based, expert-recommended stroke prevention guideline is particularly important in Low- and Middle-Income Countries (LMICs), which bear disproportional larger burden of stroke while possessing fewer resources. Focus therefore, should be on approaches enabling healthcare systems to improve control of vascular risk factors. Objective: We aimed to compare important features of stroke prevention guidelines between LMICs and High Income Countries (HICs). Methods: We systematically searched PubMed, AJOL, SciELO, and LILACS databases for stroke prevention guidelines published between January 2005 and December 2015 by country. Primary search items included: “Stroke” and “Guidelines”. We critically appraised the articles for evidence level, issuance frequency and implementation aspects to clinical practice. Results: Among 45 stroke prevention guidelines published, 28 (62%) met eligibility criteria: 7 from LMICs (25%) and 21 from HICs (75%). LMIC-issued guidelines were less likely to have conflict of interest declarations (57% vs. 100%, p=0.01), involve high quality systematic reviews (57% vs. 95%, p= 0.03), had good dissemination channels (14% vs 71%, p=0.02). The patient views and preferences were the most significant stakeholder considerations in HICs (43%, p=0.04) compared with LMICs. Conclusion: The quality and quantity of stroke prevention guidelines in LMICs are less than those of HICs and need to be significantly improved upon.

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