Zhao Wenle, Pauls Keith
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented.
A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication.
By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion.
A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality.
为防止潜在偏倚并减少重要安全性和有效性结局评估中的差异，集中式结局判定已广泛应用于多中心临床试验。不同研究中的判定程序可能差异很大。在实践中，许多多中心临床试验中结局判定程序的协调仍为手工操作，效率低下且延迟风险高。受两个大型临床试验网络需求的推动，该网络的数据管理中心在一个自主研发的临床试验管理系统中开发了一个通用结局判定模块。本文介绍了该系统的设计策略和数据库结构。
创建了一个通用数据库模型，将不同的判定程序转换为一组统一的顺序判定步骤。每个判定步骤由一个激活条件、一个锁定条件、一到五个用于捕获判定结果的分类数据项以及一个用于一般注释的自由文本字段定义。基于此模型，在自主研发的临床试验管理系统中开发了一个通用结局判定用户界面和一个通用数据处理程序，以实现结局判定的自动化协调。
截至2014年底，这个通用结局判定模块已在10项多中心试验中实施。共定义了29个判定程序，判定步骤数量从1到7不等。经验丰富的程序员在这个通用模块中实施一个新的判定程序需要1至2天。共判定了7336个结局事件，并记录了16235个判定步骤活动。在一项多中心试验中，1144份安全性结局事件提交经过了一个三步判定程序，从安全性事件病例报告表提交到判定完成的中位时间为3.95天。在另一项试验中，277个临床结局事件通过一个六步程序进行判定，从结局事件病例报告表提交到判定程序完成的中位时间为23.84天。
集成在临床试验管理系统中的通用结局判定模块使疗效和安全性结局判定的自动化协调成为现实。
