Smart Capsule for Automatic Adherence Monitoring

描述（由申请人提供）：药物依从性差对患者、临床研究结果和一般医疗保健系统有显著的负面影响。如果患者能够可靠地服用处方药物，就可以避免多达25%的医疗费用。药物依从性是临床试验中特别关注的问题。标准的依从性措施（药片计数和日记）是不准确的，但仍然昂贵，而少数可用的准确的依从性措施（例如直接观察治疗）成本高昂，在大型研究中难以实施。在以药物依从性差而臭名昭著的研究中，如药物滥用研究，不依从性将掩盖研究的真实结果，包括疗效、安全性、剂量反应和副作用，这可能会影响研究

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