Adherence Monitoring for Substance Abuse Clinical Trials

描述(由申请人提供)：对药物滥用和成瘾以及许多其他疾病和障碍的安全和有效的药物疗法的评估和选择是通过临床试验进行的，这些临床试验依赖于患者服用所研究的药物。 在指定的时间和频率。为了确保准确的疗效测量，必须知道是否遵守规定的方案。Creare建议开发一种移动依从性监测系统，以在这些临床试验期间近乎实时地记录时间和剂量信息。Creare系统包括确认性生物标记物，以确保遵守措施的准确性。该系统允许与给药时间挂钩的生态瞬时评估，提供随着时间的推移测试药物的有效性和药物安全性的额外措施。在第一阶段，我们通过实现初始原型和执行试验性的人体受试者测试来证明我们的监测系统的可行性。在第二阶段，我们将进一步开发和整合我们系统的硬件和软件组件，并在实验室和一组鸦片替代疗法的受试者中测试该系统。Creare团队非常有资格成功开发该系统并将其商业化，这要归功于Creare之前为图像处理、神经心理测试、数据共享和移动听力评估开发的算法、软件和硬件。我们的临床合作者John Mendelson博士是加州太平洋医学中心研究所(APRL-CPMCRI)成瘾和药理学研究实验室的负责人，他在非法药物使用者的临床试验方面拥有丰富的经验，并开创了我们建议的系统中使用的方法。

DESCRIPTION (provided by applicant): The evaluation and selection of safe and effective pharmacotherapies for drug abuse and addiction, as well as many other diseases and disorders, is performed through clinical trials that rely on patients taking the studied medication at the specified time and frequency. To ensure accurate efficacy measures, adherence to the prescribed regimen must be known. Creare proposes to develop a mobile adherence monitoring system to record timing and dosage information in near-real time during these clinical trials. The Creare system includes confirmatory biomarkers to ensure accuracy of the adherence measures. The system allows for ecological momentary assessments linked to dosing time that provide additional measures of efficacy and drug safety of the test medication over time. During Phase I, we demonstrated the feasibility of our monitoring system by implementing an initial prototype and performing a pilot human subject test to demonstrate feasibility. During Phase II, we will further develop and integrate the hardware and software components of our system, and test the system in the laboratory and in a cohort of subjects on opiate substitution therapy. The Creare team is extremely well qualified to successfully develop and commercialize this system thanks to algorithms, software, and hardware Creare has previously developed for image processing, neuropsychological testing, data sharing, and mobile hearing assessment. Our Clinical Collaborator, Dr. John Mendelson, head of the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute (APRL-CPMCRI), has extensive experience in clinical trials with illicit drug users, and pioneered the methods used in our proposed system.