Knowledge Representation for Computer-Aided Planning of Controlled Clinical Trials: the PATriCIa Project

Haag, Uwe

doi:10.1055/s-0038-1636829

Cited by 6 publications

(2 citation statements)

References 10 publications

(10 reference statements)

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“…For example, research has been active in areas such as the development of protocol authoring and critiquing tools [41][42][43][44][45][46][47][48], patient eligibility determination tools [49][50][51][52], clinical trials protocol repositories [5,53] protocol development, versioning and distribution management tools [54], clinical trial data capture with handheld devices and wireless technology [2,55,56], informed consent administration tools [57], and clinical trials banks [58][59][60].…”

Section: Software Architecturementioning

confidence: 99%

Design aspects of a distributed clinical trials information system

Oliveira¹,

Salgado

2006

Clinical Trials

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Backgound Clinical trials informatics has evolved through the development of multiple applications addressing distinct parts of the clinical trials cycle. This setting creates difficulties in the transport and sharing of data among applications that serve a common functionality. Purpose We present an alternative approach for the design of clinical trials information systems consisting of loosely coupled components standing on a comprehensive model of the global clinical trial process. Methods We describe how such a structure is able to support the development and implementation of complex knowledge-driven modules, such as automated database query systems, reporting systems and intelligent data-analysis tools, and how currently available internet technologies may be used to support the independent development of applications and collaboration between researchers. Results These principles were applied to the development of a fully functional system that has been in production for eight years in a diversity of pharmaceutical and academic drug trials. Marked time savings in database set-up and statistical reporting have been documented, as well as good reliability in the selection of appropriate statistical methods to clinical trial data analysis. Conclusions In order to meet the expected functionality and to avoid the proliferation of databases and software applications, clinical trials information systems need to be based on a generic model of clinical trials and on a distributed architecture.

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Section: Software Architecturementioning

confidence: 99%

Design aspects of a distributed clinical trials information system

Oliveira¹,

Salgado

2006

Clinical Trials

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“…[8][9][10][11] Other investigators have developed planning tools for clinical trial protocols, with the hope that this will lead to greater accuracy and efficiency in the conduct of the clinical trials themselves. 12,13 Some work has been done in the development of systems that are intended to manage the entire life cycle of a clinical trial. [14][15][16] These systems assist clinicians and researchers as they are carrying out the trial, and they may also yield valuable data that are useful for subsequent analyses.…”

Section: Introductionmentioning

confidence: 99%

Design and Implementation of a National Clinical Trials Registry

McCray¹,

Ide²

2000

Journal of the American Medical Informatics Association

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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.

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