Smart Capsule for Automatic Adherence Monitoring

描述（由申请人提供）：药物依从性差对患者、临床研究结果和医疗保健系统总体上具有显著的负面影响。如果患者可靠地服用处方药，则可以避免高达25%的医疗费用。药物依从性是临床试验中特别关注的问题。依从性的标准测量（药丸计数和日记）是不准确的，但仍然昂贵，而少数可用的准确的依从性测量（例如直接观察治疗）是成本高昂的，在大型研究中难以实施。在药物依从性差的研究中，如药物滥用研究，不依从性会掩盖研究的真实结果，包括疗效、安全性、剂量反应和副作用，可能使研究 如果没有准确的药物依从性测量，就毫无用处。这个快速跟踪SBIR项目将利用eTect现有的技术来创建智能胶囊，为临床研究提供准确和实时的依从性监测，特别是低依从性的高风险研究。在第一阶段，我们将开发一个原型智能胶囊，通过插入一个生物相容的无线传感器，或“标签”，1号胶囊插入00号胶囊之间。在第二阶段，我们将开发一个定制系统，用于生产大量可生产的智能胶囊。第二阶段还将包括一项60名患者的大麻依赖受试者试验，以评估智能胶囊系统的功能，将其整合到试验过程中的难易程度，以及提高对有针对性的提醒系统的依从性的潜力。I期研究的具体目的是：1.修改现有的eTect ID-Cap标签，以在“capsule-in-a-capsule”（cap-in-cap）配置2中获得最佳性能。设计和制造原型智能胶囊3.评估原型智能胶囊在稳定性、溶解性、相容性和环境测试中的性能。II期研究的具体目的是：1.重新设计电子标签以支持大批量生产2.修改Smart Capsule生产工艺，以生产用于测试和临床试验3的大批量供应品。评估Smart Capsule在先导药物滥用临床试验中的性能

DESCRIPTION (provided by applicant): Poor medication adherence has a significant negative impact on patients, clinical study outcomes, and the healthcare system in general. As much as 25% of all healthcare costs could be avoided if patients reliably took their prescribed medications. Medication adherence is of particular concern in clinical trials. Standard measures of adherence (pill counting and diaries) are inaccurate and yet still costly, whereas the few available accurate measures of adherence (e.g. direct observed therapy) are cost prohibitive and logistically difficult to implement in large studies. In studies notorious for poor medication adherence, such as drug abuse studies, non-adherence will conceal the true outcomes of the study, including efficacy, safety, dose response, and side effects, potentially rendering the study useless without accurate measures of medication adherence. This Fast-track SBIR project will utilize eTect's existing technology to create Smart Capsules that provide accurate and real-time adherence monitoring for clinical studies, particularly studies at high risk of low compliance. In Phase I we will develop a prototype Smart Capsule by inserting a biocompatible wireless sensor, or "tag", between a size 1 capsule inserted into a size 00 capsule. In Phase II we will develop a custom system for producing large quantities of production-ready Smart Capsules. Phase II will also include a 60 patient trial with marijuana-dependent subjects to evaluate the functionality of the Smart Capsule system, the ease by which it can be integrated into the trial processes, and it's potential to improve compliance with a targeted reminder system. The Specific Aims of the study in Phase I are to: 1. Modify the existing eTect ID-Cap Tag for optimum performance in 'capsule-in-a- capsule' (cap-in-cap) configuration 2. Design and manufacture prototype Smart Capsules 3. Evaluate the performance of prototype Smart Capsules in stability, dissolution, compatibility, and environmental tests. The Specific Aims of the study in Phase II are to: 1. Redesign the electronic tags to support high volume manufacture 2. Modify the Smart Capsule manufacturing processes to produce high volume supplies for testing and the clinical trial 3. Evaluate the Smart Capsule's performance in pilot drug abuse clinical trial