Vaccine trials in the developing world: Operational lessons learnt from a phase IV poliomyelitis vaccine trial in South Africa

Geldenhuys, Hennie; Waggie, Zainab; Jacks, M.; Geldenhuys, Maryke; Traut, L.; Tameris, Michèle; Hatherill, Mark; Hanekom, Willem A.; Sutter, Roland W.; Hussey, Gregory; Mahomed, Hassan

doi:10.1016/j.vaccine.2012.07.026

Cited by 5 publications

(8 citation statements)

References 7 publications

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“…A possible explanation is that trials in SSA have often had Northern sponsors who might not be familiar with or ignore setting differences. The literature confirms trial staff opinions that adapting projects to the context prevents time-consuming errors and challenges along the way [8, 21, 35]. Challenges of unadapted trials were reported more often in the French-speaking countries.…”

Section: Discussionsupporting

confidence: 61%

“…Promisingly there are developments towards a better collaboration and joint reviews between these bodies; the WHO-supported AVAREF (African Vaccine Regulatory Forum) platform was founded to support multi-national vaccine trials, but also was instrumental in the acceleration of clinical trials during the Ebola crisis [18]. Other reported challenges include the often poor and/or illiterate study participants and differing cultural values and beliefs [8, 19], which raise ethical questions [8, 20] and may lead to recruitment, consent and follow up difficulties, which slow down trial progress [8, 17, 21]. Inadequate infrastructure, particularly in rural areas, may affect clinical work, communication, access and the availability of basic refrigerated medicines, which together may also considerably slow down trials [21, 22].…”

Section: Introductionmentioning

confidence: 99%

“…Other reported challenges include the often poor and/or illiterate study participants and differing cultural values and beliefs [8, 19], which raise ethical questions [8, 20] and may lead to recruitment, consent and follow up difficulties, which slow down trial progress [8, 17, 21]. Inadequate infrastructure, particularly in rural areas, may affect clinical work, communication, access and the availability of basic refrigerated medicines, which together may also considerably slow down trials [21, 22]. The aforementioned challenges can be categorised as external factors, as they are the given conditions of the framework in which clinical trials operate in these settings.…”

Section: Introductionmentioning

confidence: 99%

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"You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

et al. 2017

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BackgroundThe costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams.MethodsWe conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts.ResultsWe found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, “planning” and “site organisation”. These themes were consistently mentioned across positions and countries. “Planning” factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. “Site organisation” factors covered staff turnover, employment conditions, career paths, workload, delegation and management.ConclusionsWe found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified internal factors and allow clinical trials to proceed more efficiently.

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Section: Discussionsupporting

confidence: 61%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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"You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

et al. 2017

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“…Previous experience at our site had taught us to expect an initial slow pace for screening and enrolment before gaining momentum, exhibiting an S-shaped enrolment rate curve 29 . However, the initial pace was even slower than expected forcing a review of our recruitment methods.…”

Section: Resultsmentioning

confidence: 94%

Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG

et al. 2013

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SummaryBackgroundNew tuberculosis (TB) vaccines are being developed to combat the global epidemic. A phase IIb trial of a candidate vaccine, MVA85A, was conducted in a high burden setting in South Africa to evaluate proof-of-concept efficacy for prevention of TB in infants.ObjectiveTo describe the study design and implementation lessons from an infant TB vaccine efficacy trial.MethodsThis was a randomised, controlled, double-blind clinical trial comparing the safety and efficacy of MVA85A to Candin control administered to 4–6-month-old, BCG-vaccinated, HIV-negative infants at a rural site in South Africa. Infants were followed up for 15–39 months for incident TB disease based on pre-specified endpoints.Results2797 infants were enrolled over 22 months. Factors adversely affecting recruitment and the solutions that were implemented are discussed. Slow case accrual led to six months extension of trial follow up.ConclusionThe clinical, regulatory and research environment for modern efficacy trials of new TB vaccines are substantially different to that when BCG vaccine was first evaluated in infants. Future infant TB vaccine trials will need to allocate sufficient resources and optimise operational efficiency. A stringent TB case definition is necessary to maximize specificity, and TB case accrual must be monitored closely.

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“…Getz et al state that protocol design may hold the key to achieving higher levels of efficiency [ 8 ]. Despite the challenges mentioned above and the apparent importance of the protocol, there is little research on how to optimize the conduct of trials in the North as well as in resource-limited countries [ 10 , 11 ]. Gheorghiade et al criticise the limited data available to support best trial practices and that we only rely on experience and judgment [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study

Vischer

Pfeiffer

Kealy

et al. 2017

glob health res policy

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BackgroundThe trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.MethodsWe used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews.ResultsProtocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures.ConclusionsOur data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.Electronic supplementary materialThe online version of this article (doi:10.1186/s41256-017-0031-1) contains supplementary material, which is available to authorized users.

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Vaccine trials in the developing world: Operational lessons learnt from a phase IV poliomyelitis vaccine trial in South Africa

Cited by 5 publications

References 7 publications

"You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

"You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG

Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study

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