Adherence Monitoring for Substance Abuse Clinical Trials

描述（由申请人提供）：通过临床试验来评估和选择安全有效的药物治疗药物滥用和成瘾，患者在规定的时间和频率服用所研究的药物。为了确保准确的疗效测量，必须知道是否遵守规定的治疗方案。Creare建议开发一个依从性监测系统，在这些临床试验期间近乎实时地报告时间和剂量信息。Creare系统包括验证性生物标志物，以确保依从性测量的准确性。它可以与其他与给药时间相关的评估相结合，提供测试化合物随时间变化的功效的额外测量。在第一阶段，我们将通过实施初始原型，执行试点人体受试者测试以证明可行性，以及设计原型系统以在第二阶段实施和测试来证明我们监测系统的可行性。Creare团队完全有资格成功开发和商业化该系统，这要归功于Creare之前开发的用于图像处理、神经心理测试、数据共享和评估的算法和软件。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，他在非法吸毒者的临床试验方面拥有丰富的经验，并开创了我们提出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 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 an adherence monitoring system to report both 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. It can be combined with other assessments linked to dosing time that provide additional measures of efficacy of the test compound over time. During Phase I, we will demonstrate the feasibility of our monitoring system by implementing an initial prototype, performing a pilot human subject test to demonstrate feasibility, and designing a prototype system for implementation and testing during Phase II. The Creare team is well qualified to successfully develop and commercialize this system thanks to algorithms and software Creare has previously developed for image processing, neuropsychological testing, data sharing, and 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. PUBLIC HEALTH RELEVANCE: Chronic drug abuse affects not only the health of the users, but also the quality of life of their families, the lives of crime victims, and car crashes caused y drivers under the influence of illicit drugs, and it weighs heavily on the law enforcement agencies and justice system. The proposed real-time, cellular phone-based medication adherence measure will greatly increase the accuracy of clinical trials for substance abuse pharmacotherapies likely to increase effective treatment options for substance abusers, thereby reducing the burden of substance abuse disorders on our society.