Core--Statistical Facility

大卫Wypij博士将指导SMAC的统计核心。他从一开始就参与了这个网络的规划，并在此之前在其他环境中与疟疾合作。SMAC的中央数据管理设施将位于五个临床研究中心之一;来自哈佛公共卫生学院的大卫·威皮吉博士将监督五个当地数据管理员和数据录入员团队，并将与网络数据协调员密切联络。他将确保数据库得到开发和维护，质量和可靠性得到证明，并根据需要编写分析和报告。当地小组将负责输入、清理和检查在各自地点收集的数据。数据协调员将合并五个SMAC研究中心提交的所有数据。色素研究及其相关的描述性疟疾信息核心库将是最耗时的，但这些团队也将参与临床试验。数据协调员将从其中一个试验中心中选出，并将与Wypij博士一起培训一年;他/她将精通所选数据库，并将学习如何编写数据分析所需的程序。数据协调员或Dr. Wypij将在第一年以及之后每年访问每个研究中心。他们将共同协助设计病例报告表，应数据安全和监测委员会的要求进行分析和撰写报告，并帮助编写最终报告和科学手稿。将向每个现场提供膝上型计算机;数据协调员在直接与Wypij博士合作时将获得一台功能更强大的台式计算机。5/然后他将带着这台计算机返回SMAC中央数据设施。坚实的统计基础设施是临床试验的一个重要方面，特别是多中心试验。网络规划小组同意上述方法，我们期待着与Wypij博士和统计小组的其他成员合作。

Dr. David Wypij will direct the Statistical Core for SMAC. He has been involved in planning this network from the beginning and has worked with malaria in other settings prior to this. The central data management facility for SMAC will be located in one of the five clinical sites; Dr. David Wypij from the Harvard School of Public Health will supervise five local teams of data managers and data entry clerks and will liaise closely with the network Data Coordinator. He will ensure that the databases are developed and maintained, that quality and reliability' can be demonstrated, and that analyses and reports are produced as needed. The local teams will be responsible for entering, cleaning and checking the data collected at their respective sites. The Data Coordinator will amalgamate all the submitted from the five SMAC sites. The pigment study, with its associated core bank of descriptive malaria information, will be most time-consuming, but these teams will be involved with the clinical trials, too. The Data Coordinator will be selected from one of the trials sites and will train for a year with Dr. Wypij; s/he will become proficient in the selected database, and will learn how to write the programs necessary for data analysis. Either the Data Coordinator or Dr. Wypij will visit each site during the first year, and every year thereafter. Together, they will contribute to the design of case report forms, conduct analyses and write reports when requested by the Data Safety and Monitoring Board, and help to prepare final reports and scientific manuscripts. Laptop computers will be provided to each field site; a more powerful desktop computer will be obtained for the Data Coordinator while she is working directly with Dr. Wypij. 5/he will then return to the SMAC central data facility with this computer. A solid statistical infrastructure is an important aspect of clinical trials, particularly multicenter trials. The network planning group agrees on the approach outlined above, and we look forward to collaborating with Dr. Wypij and the rest of the statistical team.