Lallas Costas D, Preminger Glenn M, Pearle Margaret S, Leveillee Raymond J, Lingeman James E, Schwope John P, Pietrow Paul K, Auge Brian K
Division of Urology, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
J Urol. 2004 May;171(5):1880-5. doi: 10.1097/01.ju.0000120221.39184.3c.
As randomized, prospective trials have become an integral part of clinical research, multi-institutional, collaborative research has become a necessity. However, it may be cumbersome for participants at remote facilities to participate because the submission and compilation of data and results are at times lengthy processes. Internet based clinical studies have been found to be a rapid, easily accessible, safe and secure method of performing multi-institutional trials.
The Internet was used at geographically distant medical centers to enroll patients into a multi-institutional, prospective, randomized trial for the management of lower pole renal calculi. The Clinical Research Web-based Information Center secure computer web based program (Simplified Clinical Data Systems, Amherst, New Hampshire) was established to input preliminary demographic and clinical data, randomize patients, and collect treatment and followup information without paper chart documentation. The primary investigators in the study were sent a questionnaire to determine the ease of use of this Internet based program. The results were tabulated.
A total of 112 patients from 21 participating institutions were randomized into the secure web site for inclusion into a lower pole renal stone clinical trial. Of the investigators 64% responded to the questionnaire. The majority of those having enrolled patients into the study reported no difficulties or only minimal difficulties in navigating the web site. Moreover, investigators from remote locations throughout North America described the improved convenience, rapid transmission of information, and ability to review and update patient data as benefits of enrolling patients using the Internet. The Internet based system also permits the prompt compilation of data at the host research site for performing interim data assessments and eventually the final analysis.
A web based data collection center allows for large, multi-institutional trials to be done with unprecedented accuracy and efficiency. Through centralization of data capture, and real-time study monitoring and data analysis the system removes these responsibilities from those at individual test sites, permitting investigators to concentrate instead on other aspects of the study and its progress. State-of-the-art security protects all information to ensure confidentiality. The Internet may prove to be an invaluable tool in the future of clinical research.
随着随机前瞻性试验已成为临床研究不可或缺的一部分，多机构协作研究变得十分必要。然而，对于偏远机构的参与者来说，参与研究可能很麻烦，因为数据和结果的提交与汇总有时是漫长的过程。基于互联网的临床研究已被发现是进行多机构试验的一种快速、易于访问、安全可靠的方法。
在地理位置遥远的医疗中心利用互联网将患者纳入一项多机构、前瞻性、随机试验，以管理下极肾结石。建立了基于网络的临床研究信息中心安全计算机程序（简化临床数据系统，新罕布什尔州阿默斯特），用于输入初步人口统计学和临床数据、随机分配患者以及收集治疗和随访信息，无需纸质病历记录。向该研究的主要研究者发送问卷，以确定这种基于互联网的程序的易用性。对结果进行了列表统计。
来自21个参与机构的112名患者被随机分配到安全网站，纳入下极肾结石临床试验。64%的研究者回复了问卷。大多数将患者纳入研究的研究者表示在浏览网站时没有困难或仅有极小的困难。此外，来自北美各地偏远地区的研究者称，使用互联网纳入患者具有便利性提高、信息快速传递以及能够查看和更新患者数据等优点。基于互联网的系统还允许在主办研究地点迅速汇总数据，以进行中期数据评估并最终进行最终分析。
基于网络的数据收集中心能够以前所未有的准确性和效率进行大型多机构试验。通过集中数据采集、实时研究监测和数据分析，该系统将这些职责从各个试验地点的人员身上移除，使研究者能够转而专注于研究的其他方面及其进展。先进的安全性保护所有信息以确保保密性。互联网可能会被证明是未来临床研究中一项非常有价值的工具。
