Core--Statistical Facility

点击翻译按钮获取中文摘要

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.