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

Kolawole Salami,Nadia G Tornieporth,Mike Zoglowek,Nathalie Imbault,Aljoscha Erlebach,Johanna Urban

doi:10.1186/s40814-020-00567-4

Kolawole Salami, Nadia G Tornieporth + Show 4 more

Open Access

https://doi.org/10.1186/s40814-020-00567-4

Copy DOI

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.

Highlights

Immunization is one of the most beneficial and costeffective disease prevention measures
A total of 44 sites were identified in 8 Lassa fever (LF)-affected countries (Nigeria, Ghana, Sierra Leone, Liberia, Benin, Mali, Burkina Faso, and Guinea) through clinical trial registries and viral hemorrhagic fever consortia
The database was closed at the end of week 9, with 35 (79.5%) sites giving a favorable response and 2 (4.5%) sites declining to participate citing lack of interest in conducting clinical trials at this time, while no response was obtained from 7 sites (16%)

Summary

Introduction

Immunization is one of the most beneficial and costeffective disease prevention measures. Many factors play a role in the appropriateness of site selection for sponsored multi-center clinical studies. These include having access to patients meeting the eligibility criteria, expertise in the outcome (disease) of interest, presence of facilities or equipment, and trained investigators willing and able to perform the research. A significant number of clinical trials are experiencing delays due to many factors, the majority of which are associated with the appropriateness of the clinical trial site and challenges with patient recruitment [5,6,7]. 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

Objectives

Methods

Results

Discussion

Conclusion