Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA.
Clin Trials. 2010 Apr;7(2):174-82. doi: 10.1177/1740774509358748. Epub 2010 Jan 18.
Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost.
To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression.
The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems.
The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports.
Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is increased and the value of using this system for other trials is reduced.
Web-based central computerized systems offer time-saving, secure options for managing clinical trial data. The choice of a commercially available system or an internally developed system is determined by the requirements of the study and users. Pros and cons to both approaches were discussed. If the intention is to use the system for various trials (single and multi-center, phases I-III) across various therapeutic areas, then the overall design should be a generic structure that simplifies the general application with minimal loss of functionality.
临床试验的研究者和赞助商投入了大量的资源和精力来进行试验，他们经常面临数据管理、项目管理和数据质量控制方面的日常挑战。为了避免在等待数月后才获得研究进展报告，研究者需要能够使用实时数据来协调和管理研究活动，涉及所有研究团队成员，包括现场研究者、监督委员会、数据和安全监测委员会以及医学安全监测员。基于网络的数据管理系统开始满足这一需求，但区分一个系统与另一个系统的是用户需求/要求和成本。
以一个多中心临床试验为例，说明一种基于网络的数据和项目管理系统的开发和实施，该试验旨在测试重复经颅磁刺激治疗与假刺激治疗重度抑郁症患者的优越性。
作者讨论了在本研究中不使用商业上可用系统的原因，并描述了为 OPT-TMS 研究开发自己的基于网络系统的方法。分享了时间表、努力、系统架构和经验教训，希望这些信息能为临床试验研究人员和软件开发人员提供更高效、更用户友好的系统。
开发人员使用通用和定制应用程序代码的组合，使系统能够灵活适应研究的需求。系统的功能包括：中心参与者注册和随机分组；现场安全数据输入；参与者进度/研究日历；安全数据报告；设备核算；监测员验证；以及用户可配置的通用报告和内置定制报告。
与创建通用代码应用程序相比，硬编码更能有效地解决特定于项目的问题。由于这种策略，系统的维护要求增加了，并且使用该系统进行其他试验的价值降低了。
基于网络的中央计算机化系统为管理临床试验数据提供了节省时间、安全的选择。选择商业上可用的系统或内部开发的系统取决于研究和用户的要求。讨论了两种方法的优缺点。如果意图是在不同的治疗领域使用该系统进行各种试验（单中心和多中心、I-III 期），那么总体设计应该是一种通用结构，简化一般应用程序，同时最小化功能损失。
