Internet based multi-institutional clinical research: a convenient and secure option.

摘要

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.