Computerized Drug Evaluation System

描述（来自申请人摘要的逐字描述）：本申请的总体目标 一个项目是开发一个计算机化的实地评价系统， 药物治疗依从性，并评估副作用和治疗过程中 药物监测现场评估系统（MMFES）。 该产品将允许临床药物试验研究人员没有编程 具备制定定制现场评估协议的经验， 掌上电脑在研究中的主题。该程序将使用主机 PC上的管理软件（HMS）、 掌上电脑，以及轻松上传和下载协议和数据的设施， 无论是本地还是远程。HMS将用于开发现场评估 评估自我监测变量（如药物依从性、副作用）的方案 影响，以及门诊访视之间的泌尿学变化。这些评估 然后将协议下载到掌上电脑（PDA）上并在其上实现 电脑由此产生的掌上电脑程序将允许实时监控 任何适合研究目标的时间表。该计划的目的 具有广泛的分支功能，以提供额外的查询或 在特定条件下的指示。掌上电脑上收集的数据可以 本地或远程上传到HMS进行后续分析，或 导入到其他数据库或统计程序。第一阶段项目将 强调开发和测试一个原型MMFES，但两个小规模 将进行评价。其中一个将涉及一个可用性测试， 在药物评估专业人员的样本中进行了程序。第二个将涉及 MMFES在“类似”药物试验中的初步试验， 使用尼古丁口香糖。 拟定商业应用： 该产品可广泛应用于药物研究和临床 正在评估药物的环境。 而不是使用纸和纸的日志， 跟踪用药依从性、副作用和药物学变化，药物研究人员 医疗专业人员将能够构建他们想要的现场评估协议 并在掌上电脑上为患者的研究参与者实施本方案。

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.