Research Project
8199012
DESCRIPTION (provided by applicant): Ai Cure Technologies LLC, was established in 2009 to develop webcam software solutions for mobile devices and other computing platforms that automate and reduce the cost of monitoring patient behavior and medication adherence. Poor medication adherence is one of the healthcare system's greatest challenges. More than two million serious adverse events and about 100,000 deaths occur annually due to this problem. Total US healthcare costs of drug-related morbidity, including poor adherence, are estimated at $290 billion per year. In clinical trials, adherence levels for populations with chronic conditions range from 43% to 78%, the high cost of clinical trials being partly attributable to inefficiencies created by poor adherence. As clinical trials become larger, and more move outside the US, tracking patient behavior becomes more difficult, as does the burden on the FDA to monitor these sites. Traditional monitoring methods such as pill counting, patient interviews, and blood work have proven unreliable. Indeed, a recent clinical trial employing these traditional monitoring methods was confirmed to have failed for poor medication adherence. Products such as smart blister packs and MEMS caps are costly and do not confirm medication has been taken. Direct observation therapy is effective to confirm medication adherence;but is labor-intensive, patient intrusive, and expensive. Ai Cure Technologies will provide a webcam software solution for distribution by clinical trial sponsors to automate direct observation of medication administration and provide an audit trail of medication adherence. The solution will provide reliable data to the research community and policy-makers to improve overall health outcomes and rein in soaring costs. The solution will also act as a tool for the FDA to better regulate trials before drugs come to market. PUBLIC HEALTH RELEVANCE: In clinical trials, whether or not participants take their prescribed medication and to what degree is neither well understood nor reliably monitored through existing and antiquated methods such as pill counting or patient interviews. This means that it is difficult to provide an accurate assessment on drug efficacy or safety within a prescribed regimen and over the course of a clinical trial. AiView will provide a system for automatically determining medication adherence of clinical trial patients, and allow access to this data by clinical trial managers.
