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A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries

  • Background: We 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. Methods: We 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. Results: This 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. Conclusion: It 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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Metadaten
Author:Kolawole SalamiORCiD, Nathalie Imbault, Aljoscha Erlebach, Johanna Urban, Mike Zoglowek, Nadia G. Tornieporth
URN:urn:nbn:de:bsz:960-opus4-16480
DOI original:https://doi.org/10.1186/s40814-020-00567-4
ISSN:2055-5784
Parent Title (English):Pilot and feasibility studies
Document Type:Article
Language:English
Year of Completion:2020
Publishing Institution:Hochschule Hannover
Release Date:2020/05/12
Tag:Assessment; Capacity strengthening; Clinical trials; Endemic countries; Lassa fever vaccines; Scorecard; Site assessment; Site selection
GND Keyword:Lassa-Fieber; Impfstoff; Klinisches Experiment
Volume:6
Issue:1
Link to catalogue:1698693990
Institutes:Fakultät III - Medien, Information und Design
DDC classes:610 Medizin, Gesundheit
Licence (German):License LogoCreative Commons - CC BY - Namensnennung 4.0 International