ArticlePilot and feasibility studies2020
A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries.
Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Identifying and assessing the capacity and experience of trial sites in low- and middle-income countries for high-quality randomised drug trials in maternal and perinatal health.BMJ global health · 2025Article
- Assessing the Brighton Collaboration Case Definition of Sensorineural Hearing Loss in Ghana.The American journal of tropical medicine and hygiene · 2022Article
- COVID-19 site readiness initiative: Building clinical trial capacity for vaccine efficacy trials in Latin America in response to the pandemic.Vaccine: X · 2022Article
- The promise, problems, and pitfalls of including pregnant women in clinical trials of Lassa fever vaccine: a qualitative assessment of sub-Sahara Africa investigators' perception.The Pan African medical journal · 2022Article
- Tracking the uptake and trajectory of COVID-19 vaccination coverage in 15 West African countries: an interim analysis.BMJ global health · 2021Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe sought to develop and test an objective scorecard-based system for assessing and categorizing available research sites in Lassa fever-affected countries based on their preparedness and capability to host Lassa fever vaccine clinical trials.
methodsWe mapped available clinical research sites through interrogation of online clinical trial registries and relevant disease-based consortia. A structured online questionnaire was used to assess the capability of clinical trial sites to conduct Lassa fever vaccine clinical trials. We developed a new scoring template by allocating scores to questionnaire parameters based on perceived importance to the conduct of clinical trials as described in the WHO/TDR Global Competency Framework for Clinical Research. Cutoff points of 75% and 50% were used to categorize sites into categories A, B, or C.
resultsThis study identified 44 clinical trial sites in 8 Lassa fever-affected countries. Out of these, 35 sites were characterized based on their capacity to hold Lassa fever vaccine clinical trials. A total of 14 sites in 4 countries were identified as ready to host Lassa fever vaccine trials immediately or with little support.
conclusionIt is feasible to hold Lassa fever vaccine trials in affected countries based on the outcome of the survey. However, the findings are to be validated through sites' visits. This experience with a standardized and objective method of the site assessment is encouraging, and the site selection method used can serve as an orientation to sponsors and researchers planning clinical trials in the region.
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