2002 |
Ott, Geoffrey E |
R43Activity Code Description: To support projects, limited in time and amount, to establish the technical merit and feasibility of R&D ideas which may ultimately lead to a commercial product(s) or service(s). |
Clinipad: Handheld Assessment System For Clinical Trials @ Medical Decision Logic, Inc.
DESCRIPTION (provided by applicant): This Phase I application proposes to assess the feasibility of a handheld personal digital assistant (PDA) system ("CliniPadTM") designed to support multi-site clinical trials in the recording, transmission, and storage of subject assessment and rating data. Clinical subject assessment and rating data collection using handheld PDA electronic source documents (ESDs) will improve both the efficiency and quality of clinical trials. Both of these improvements will in turn increase the quality of public health, and both hold potential for commercial value in the pharmaceutical sector where clinical trials are a necessary and on-going procedure. CliniPad will present interview and rating forms to the rater on their PDA, including forms the user has created. From there the user will select subject ratings and other notations from an on-screen visual display, and the data will be stored on the PDA. Data will be transferred from the PDA to a desktop computer, and then from the desktop computer to a central Internet web server, where data from multiple trial sites will be maintained, managed, and accessible from multiple sites. On the PDA, desktop computer, and web server, the data will be encrypted, password-protected, and stored in a database. There are four basic components to the CliniPad system's end-to-end data gathering and management infrastructure: (1) a form creation application; (2) the PDA data gathering applet; (3) server-based management and communication software; and (4) a back-end database. The form creation application allows users to design their own subject rating forms. The handheld data gathering applet allows users to use these forms on their PDA to collect subject ratings. The server software will handle all form and rating data transfers between the central server and the desktop computer (and the PDA in Phase II). The back-end database will provide a central management for data from all sites, and allow role-based secure access to data. PROPOSED COMMERCIAL APPLICATION: The health industry relies on clinical trials for the marketing of its products, and a system that facilitates and improves these trials will be useful to companies dependent upon clinical trial results for income.
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0.909 |
2002 — 2006 |
Ott, Geoffrey E |
R43Activity Code Description: To support projects, limited in time and amount, to establish the technical merit and feasibility of R&D ideas which may ultimately lead to a commercial product(s) or service(s). R44Activity Code Description: To support in - depth development of R&D ideas whose feasibility has been established in Phase I and which are likely to result in commercial products or services. SBIR Phase II are considered 'Fast-Track' and do not require National Council Review. |
Diagnostic Logic and Adaptive Assessment For Psychiatry @ Medical Decision Logic, Inc.
DESCRIPTION (provided by applicant): This SBIR Phase I application proposes to extend an existing multi-tier Internet client-server system ("CliniMetricar") by integrating active diagnostic logic. CliniMetrica currently provides systematic psychiatric assessment using the World Health Organization (WHO) Schedules for Clinical Assessment in Neuropsychiatry (SCAN, version 2.1). CliniMetrica automatically indexes digital audio recording of assessment interviews, and was developed with SBIR support from NIMH Digital video functions are currently being implemented and tested with additional NIMH support, as are functions to support remote psychometrics for the training and monitoring of interviewers. The CliniMetrica system is increasing in sophistication and functionality, and has applications for clinical research (e.g., clinical trials) as well as for more routine clinical practice. The current lack of fully developed and tested diagnostic functionality is a major gap. A number of potential customers have requested integrated DSM-IV and/or lCD-10 diagnostic results to be automatically linked to assessments. In order to meet this market need, we propose to implement the DSM-IV and ICD-10 nosologic systems as two classification knowledge bases that a logic engine will process to generate diagnostic results. These logical functions are difficult to implement and manipulate with procedural languages (e. g. C + +). so the use of a logic engine provides significant technical benefits. This diagnostic logic version of CliniMetrica is referred to as "CliniMetrica-Dx." To assist raters in thorough examination and to support adaptive assessment, a user interface coupled to logic processing modules will allow tracking the diagnostic status of a subject (the sets of true, false, partially true, or partially false DSM-IV and lCD-10 diagnoses during assessment. The logic engine will dynamically generate assessment item subsets (currently from the SCAN) needed to rule-in or rule-out DSM-IV and lCD-10 diagnoses. During the assessment, presentation of these symptom sets to the assessor can further guide the interview. By narrowing the "search space," the efficiency of assessments will be increased. By formalizing the search, reliability and validity can be enhanced In addition, to provide support for nosologic research and development, in Phase II the system will include mappings between DSM-IV and lCD-10, and between current and future versions of the DSM and lCD. The CliniMetrica-Dx system as an application framework will generalize to other clinical psychiatric assessment instruments such as the SCID, to adaptive self-report systems, and to other medical specialties. It also will have applications for education and training.
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0.909 |