ABSTRACT
ClinicalTrials.gov is a Web-based system intended for a diverse audience, including patients, family members and other members of the public. Throughout the system design and development process, our decisions have been driven by usability concerns. We first describe the overall design of the site, including the home page, which provides a site overview and rapid access to the information contained within it. Next we discuss the data presentation format which has been standardized in spite of data coming to us from many different sources. We provide a detailed description of the search and browse features that are intended to simplify the complexities of medical terminology and support information discovery. We conclude with a review of our evaluation activities and future plans.
Subject(s)
Clinical Trials as Topic , Information Storage and Retrieval/methods , Internet , Databases as Topic/organization & administration , Evaluation Studies as Topic , National Institutes of Health (U.S.) , Unified Medical Language System , United States , User-Computer InterfaceABSTRACT
The authors have developed a Web-based system that provides summary information about clinical trials being conducted throughout the United States. The first version of the system, publicly available in February 2000, contains more than 4,000 records representing primarily trials sponsored by the National Institutes of Health. The impetus for this system has come from the Food and Drug Administration (FDA) Modernization Act of 1997, which mandated a registry of both federally and privately funded clinical trials "of experimental treatments for serious or life-threatening diseases or conditions." The system design and implementation have been guided by several principles. First, all stages of system development were guided by the needs of the primary intended audience, patients and other members of the public. Second, broad agreement on a common set of data elements was obtained. Third, the system was designed in a modular and extensible way, and search methods that take extensive advantage of the National Library of Medicine's Unified Medical Language System (UMLS) were developed. Finally, since this will be a long-term effort involving many individuals and organizations, the project is being implemented in several phases.
