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Computerized Drug Evaluation System

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 1R43HL065107-01A2
Amount: $161,128.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
12007 SUNRISE VALLEY DR, STE 480
RESTON, VA 22091
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM RILEY
 () -
Business Contact
Phone: (703) 758-1400
Email: ALBEHAR@LIFESIGN.COM
Research Institution
N/A
Abstract

DESCRIPTION (Verbatim from the Applicant's Abstract): The overall goal of this
project is to develop a computerized field evaluation system to monitor
medication compliance and assess side effects and symptomatology during
clinical drug trials (Medication Monitoring Field Assessment System, MMFES).
The product will allow clinical drug trial researchers with no programming
experience to set up customized field evaluation protocol to be delivered via
palmtop computer to the subjects in the study. The program will use host
management software (HMS) on a PC, palmtop performance software (PPS) on the
palmtop, and the facility for easy uploads and downloads of protocols and data,
both locally and remotely. The HMS will be used to develop field assessment
protocols to assess self-monitored variables such as medication adherence, side
effects, and changes in symptomatology between office visits. These assessment
protocols will then be downloaded to and implemented on a palmtop (PDA)
computer. The resulting palmtop program will allow for real-time monitoring on
whatever schedule appropriate to the research goals. The program is designed
with extensive branching capabilities to provide additional queries or
instructions under specified conditions. Data collected on the palmtop can then
be uploaded, either locally or remotely, to the HMS for subsequent analysis or
importing to other databases or statistical programs. The Phase I project will
emphasize development and testing of a prototype MMFES, but two small-scale
evaluations will be implemented. One will involve a usability test of the
program in a sample of drug evaluation professionals. The second will involve
an initial trial of the MMFES in an "analogue" drug trial with participants
using nicotine gum.
PROPOSED COMMERCIAL APPLICATION:
This product could have broad applicability in a wide range of drug research and clinical
settings where medications are being evaluated. Instead of using pencil-and-paper logs to
track medication compliance, side effects, and symptomatology changes, drug researchers
and medical professionals will be able to construct the field assessment protocol they desire
on the PC and implement this protocol for study participants of patients on a palmtop computer.

* Information listed above is at the time of submission. *

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