Salami Kolawole, Imbault Nathalie, Erlebach Aljoscha, Urban Johanna, Zoglowek Mike, Tornieporth Nadia G
1World Health Organization, Geneva, Switzerland.
Coalition for Epidemic Preparedness and Innovations, London, UK.
Pilot Feasibility Stud. 2020 Feb 13;6:24. doi: 10.1186/s40814-020-00567-4. eCollection 2020.
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.
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.
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.
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.
我们试图开发并测试一种基于客观记分卡的系统，用于根据受拉沙热影响国家现有研究站点开展拉沙热疫苗临床试验的准备情况和能力，对其进行评估和分类。
我们通过查询在线临床试验注册库和相关疾病联盟来确定可用的临床研究站点。使用结构化在线问卷评估临床试验站点开展拉沙热疫苗临床试验的能力。我们根据世界卫生组织/热带病研究与培训特别规划署全球临床研究能力框架中所述的对临床试验开展的重要性，为问卷参数分配分数，从而开发了一种新的评分模板。使用75%和50%的临界点将站点分为A、B或C类。
本研究在8个受拉沙热影响的国家中确定了44个临床试验站点。其中，35个站点根据其开展拉沙热疫苗临床试验的能力进行了特征描述。在4个国家共确定了14个站点，它们已准备好立即或只需很少支持就能开展拉沙热疫苗试验。
根据调查结果，在受影响国家开展拉沙热疫苗试验是可行的。然而，研究结果有待通过实地考察进行验证。这种标准化和客观的站点评估方法的经验令人鼓舞，所采用的站点选择方法可为计划在该地区开展临床试验的赞助商和研究人员提供指导。
