SBIR-STTR Award

Clinical trials of investigational new drugs (INDs) involve the collection display and analysis of large amounts of data. The present proposal is to develop a computer system for clinical trial studies that takes advantage of the unique capabilities of the Hand-Held Computer (HHC), a powerful microcomputer approximately 3" high by 8" long. The small size and light weight of the HHC makes it possible to collect and process data even at times and places where larger computers would be inaccessible, such as the homes of outpatients, or an inpatient's bedside. The HHC could provide alarms and prompts to insure that patients and nurses know when medications, assessments, and visits to the laboratory are due. The HHC can administer certain assessments itself. Data such as test results, sid effects, dosages, and symptoms could be quickly recorded and automatically stamped with the date and time. After the system is developed, it will be refined and evaluated in a simulated clinical trial study. The evaluation will assess its acceptance by patients and clinical staff, the amount of time necessary to train the users of the system, and the ability of the system to obtain data in a timely, accurate way.National Institute of General Medical Sciences (NIGMS)

During Phase I, Westchester Distribution Systems developed and tested a system that uses handheld computers (HHCs) to facilitate clinical trials of therapeutic drugs. The system is flexible and can be used in a wide range of protocols. The HHC remains with the patient throughout the clinical trial. Its functions include prompting the patient to take medications, administering rating scales, and asking the patient about progress and side effects. It can detect patterns of responses by the patient and present special prompts when changes in the patient's condition warrant. When the patient visits the clinic, the data from the HHC are uploaded to a personal computer for printout and analysis.During Phase II, the HHC will be used in three clinical trial studies to determine whether the HHC increases patient compliance with the study protocols, as well as increasing the accuracy and detail of the collected data. Data collected on the HHC will be compared with data collected through patient interviews during periodic clinic visits. The studies will determine how easy it is for patients and staff to use the system, and the costs involved.Awardee's statement of the potential commercial applications of the research:The HHC system will be desirable to pharmaceutical firms and to clinical trials research laboratories. This system can increase the reliability of clinical trials and get new drugs to the public faster.National Institute of General Medical Sciences (NIGMS)