Mehta Shantanu, Goyal Vishal, Singh Kavita
Clinical Development, Malaria Vaccine Development Program, International Centre for Genetic Engineering and Biotechnology Campus, New Delhi, India.
Perspect Clin Res. 2015 Apr-Jun;6(2):77-81. doi: 10.4103/2229-3485.154001.
An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving. In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.
配备适当设备和人员的一期临床试验单元对于首次人体临床试验的顺利开展至关重要。首次人体预防性疫苗试验需要临床试验场所的基本基础设施、经验丰富且专注的场所工作人员以及健康成年人作为志愿者。该设施应配备设备、提供应急服务、设有实验室、药房和存档处。在设计、基础设施、工作流程和人力方面，用于测试新型疫苗或药物的一期临床试验单元颇为相似。然而，在用新的或新型疫苗进行一期临床试验的试验前场所选择过程中，有一些重要因素需要考虑。
