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Global health
Research
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
  1. Samuel R P Franzen1,2,
  2. Clare Chandler3,
  3. Sisira Siribaddana4,
  4. Julius Atashili5,
  5. Brian Angus6,
  6. Trudie Lang1
  1. 1 The Global Health Network, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK
  2. 2 Oxford Policy Management, Oxford, UK
  3. 3 Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK
  4. 4 Department of Medicine, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
  5. 5 Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon
  6. 6 Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford, Oxford, UK
  1. Correspondence to Dr Samuel R P Franzen; sam.franzen{at}opml.co.uk

Abstract

Objectives In 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.

Design Prospective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).

Setting Case studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).

Participants Local 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 measures Discussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.

Results Institutions 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.

Conclusions Barriers 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.

  • Human Resource Management
  • Organisational Development
  • Qualitative Research
  • Tropical Medicine

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-017246

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    Footnotes

    • Contributors SRPF conceived, designed and implemented the study, analysed the data and drafted the manuscript with input and assistance from CC, BA and TL. SS and JA collaborated on the design, implementation, interpretation of data and critically revised and reviewed versions of the manuscript. All authors, except JA, approved the final version of the manuscript.

    • Funding This work was supported by The Global Health Network, a Bill and Melinda Gates Foundation funded project (grant reference: OPP1053843), and in part by The Medical Research Council and Nuffield Department of Medicine Doctoral Prize Studentship. The funders had no role in study sponsorship.

    • Competing interests None declared.

    • Ethics approval The study was approved by the University of Oxford Tropical Research Ethics Committee (OXTREC Reference 70-11); Ministry of Health, Cameroon (Ref: 631-07-12); University of Yaoundé, Faculty of Medicine and Biomedical Sciences (Ref: 0694); University of Buea, Faculty of Health Sciences (Ref: 2011-12-0041); and University of Sri Jayewardenepura, Faculty of Medical Sciences (Application No: 636/12).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The research protocol, methodology and case-specific data and reports are available online at: https://globalhealthtrials.tghn.org/articles/strategies-developing-sustainable-health-research-capacity-low-and-middle-income-countries/.