Hospitalizations and poor health outcomes due to medication nonadherence cost the U.S about $290 billion each year. In addition, poor adherence prevents researchers from properly assessing a drug in clinical trials which contributes to the high failure rate. Clinical trials can cost $1 billion or more and they most often fail because researchers can’t prove a therapy’s effectiveness or safety.
Although researchers already have several options for estimating adherence, such as pill counting and using medication containers that record and track administration, these methods can’t confirm actual intake. Also, direct observation of patients is costly, invasive, impractical, plus the fact that self-reporting of medication behaviors by patients can be imprecise and unreliable.
To combat this problem Adam Hanina joined forces with Laura Shafner, and Gordon Kessler J.D to develop an artificial intelligence smartphone application that would visually confirm medication ingestion so the right patient would take the right medication at the right time.
To develop and test the app, the team’s startup company AiCure www.aicure.com received a “Small Business Innovation Research” (SBIR) www.sbir.gov Phase 1 grant in 2011 from NIH’s National Center for Advancing Translational Sciences (NCATS) http://ncats.nih.gov. With initial SBIR funding, the AiCure team hired an artificial intelligence engineer to develop the monitoring app.
Using a mobile device’s camera, software algorithms confirms the identities of the patient, medication, and verifies the intake. The app sends this information to a cloud-based dashboard enabling researchers or healthcare providers to monitor adherence and identify adherence issues in real time. Providers are able to communicate with patients through the dashboard to offer immediate assistance.
The app also gives interactive instructions, reminders, and other suggestions to enable patients to further increase their adherence. Right now, the technology monitors pill intake, but it can also be adapted to recognize any form of administration, such as injections or oral liquids.
With the Phase 1 grant, the AiCure team successfully demonstrated that the platform was technically feasible and able to confirm that patients had taken their medication. Then NCATS awarded the company a Phase 2 SBIR award in 2013.
This funding proved that the technology could be used to determine blood levels and showed that the app can also improve adherence rates in schizophrenia and stroke patient populations. The AiCure team expects to publish study results later in 2016.
The company is further expanding their enterprise, reports Hanina, “The NIH support has enabled the company to attract and leverage an additional $12.25 million in financing from venture capital investors.”
The company also has contracts with five of the top 12 global pharmaceutical companies to provide adherence monitoring for clinical trials for experimental drugs. One of these companies, Takeda Pharmaceutical U.S.A., Inc. www.takeda.us, is testing the technology in a clinical trial for patients with psychiatric illnesses.
In addition to the company’s work with the drug development industry, the AiCure team is testing the platform in NIH studies being done on substance abuse and partnering with government organizations and insurance companies on population health contracts in infectious and cardiovascular disease.