Data Management and Biostastics Core

这个数据管理和生物统计核心将支持和加强关于利什曼病的化疗、免疫学和生态学的项目。作为一项随机临床试验，化疗项目在数据管理和分析方面有更严格的要求，因此受到更多的重视。总体目标是确保CIDEIM(主要外国合作者)的数据管理和生物统计能力达到较高的国际标准，并且是可持续的。相对于生物统计，目前的数据管理能力较低，需要进一步加强。为了达到总目标，我们确定了五个具体目标，并规划了以下活动。1)达到拟议数据管理的准确性和安全性所要求的标准 项目。我们将使用耶鲁大学开发的TrialDB包开发定制数据管理系统，2)使CIDEIM能够在未来的项目中保持这些标准。CIDEIM人员将接受TrialDB培训，当他们从耶鲁转到CIDEIM时，他们将运行定制系统。3)在设计、规划和实施拟议干预试验的统计方面达到所需标准。CIDEIM和耶鲁大学的经验丰富的统计学家与试验调查人员一起构建了试验设计，以赋予足够的统计权力；最大限度地减少偏见；并通过计划中的中期分析，允许提前停止。4)制定和实施数据和安全监测计划，并召开数据安全和监测委员会(数据安全和监测委员会)。虽然试验是第二阶段，而不是第三阶段，但由于试验的多点性质，以及包括儿童在内，我们决定召集一次dsmb来监测进展并向调查人员提供建议。5)制定并执行试验统计分析计划。试验有一个明确的二元终点，计划中的分析将产生有效的统计推断，考虑到先前的中期分析等因素，以及可能需要使用精确的、而不是渐近的Logistic回归。

This Data Management and Biostatistics Core will support and strengthen projects on the chemotherapy, immunology, and ecology of leishmaniasis. As a randomized clinical trial, the chemotherapy project has more stringent requirements in terms of data management and analysis, so receives greater emphasis. The general objective is to ensure that the data management and biostatistics capacities of CIDEIM (the Major Foreign Collaborator) reach high international standards, and are sustainable. Relative to biostatistics, the current data management capacity is lower, so requires more strengthening. In order to reach the general objective, we have set five specific aims, and planned the following activities. 1) To attain the required standards of accuracy and security in the data management of the proposed projects. We will develop custom data management systems using the TrialDB package developed in Yale, 2) To enable CIDEIM to sustain these standards for future projects. CIDEIM personnel will be trained in TrialDB, and will run the custom systems when they have been transferred from Yale to CIDEIM. 3) To attain the required standards in statistical aspects of design, planning and execution of the proposed intervention trial. Experienced statisticians at CIDEIM and Yale have, together with the trial investigators, constructed the trial design to give adequate statistical power; to minimize bias; and, by means of a planned interim analysis, to allow for early stopping. 4) To devise and implement a Data and Safety Monitoring Plan, and convene a Data Safety and Monitoring Board (DSMB). Although the trial is Phase II, rather than III, due to the multisite nature of the trial, and inclusion of children, we have decided to convene a DSMB to monitor progress and advise the investigators. 5) To devise and execute a plan for statistical analysis of the trial. The trial has a well defined binary endpoint, and the planned analysis will yields valid statistical inference, taking into account factors such as the prior interim analysis, and the possible need to use exact, rather than asymptotic, logistic regression.