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Director’s Corner

Aug. 19, 2016: Tackling the Adherence Challenge at the Culmination of the Translational Odyssey

Christopher Austin

An oft-cited component of NCATS’ mission is getting more treatments to more patients more quickly. It’s tempting to assume that once a potentially life-saving therapy is developed in the laboratory, shown to be safe and effective in human trials, and enters clinical use, its health benefits are assured. But in fact, getting an intervention — a new drug, for example — to those who need it can take more than a decade, with many lives unnecessarily lost as a result. One reason for this is that patients often don’t take drugs as prescribed. This problem — called medication nonadherence — can be a major hurdle at the far end of the translational spectrum.

Patients struggle with adherence for numerous reasons, such as unpleasant side effects, hard-to-understand instructions, complex dosing schedules, and high prescription costs. Experts estimate that,  on average, medication adherence is around 50 percent. Approximately 20 percent to 25 percent of prescriptions are never filled; of those that are, 20 percent are not consumed.

The potential consequences of nonadherence are serious. The resulting hospitalizations and poor health outcomes cost the U.S. approximately $290 billion each year. In addition, poor adherence prevents researchers from properly assessing drugs in clinical trials, contributing to a high failure rate for these studies. Clinical trials can cost $1 billion or more, and they most often fail because researchers cannot prove a therapy’s effectiveness or safety. Just as concerning, noncompliance during a trial may cause researchers and regulators to miss harmful side effects and allow unsafe drugs to enter the market.

As in all other areas of translation, NCATS is developing, demonstrating and disseminating new technologies and approaches to improving medication adherence. For example, through its Small Business Innovation Research (SBIR) program, NCATS funded the work of a startup company, AiCure, to develop a remarkable artificial intelligence smartphone application that visually confirms a patient’s identity and medication intake. In other words, the technology helps ensure that the right patient takes the right medication at the right time. This video shows how the app works. AiCure now is under contract with five of the top 12 U.S. pharmaceutical companies to use the application to improve medication adherence in clinical trials. The team also intends to offer the technology for outpatient clinical care.

Another example is from the South Carolina Clinical and Translational Research Institute at the Medical University of South Carolina (MUSC). With support from NCATS’ Clinical and Translational Science Awards (CTSA) Program, MUSC researchers are developing, studying and implementing mobile technology to improve patient adherence to medication and therapy. Their work includes the design of special electronic pill bottle caps, medication dispensers and blood pressure monitors that use Bluetooth technology paired with smartphone apps to monitor and enhance adherence to treatment regimens.

Through these and other efforts to increase the efficiency of translation, NCATS is working to ensure that all patients receive the full benefits of promising new interventions as rapidly as possible.

Christopher P. Austin, M.D.
National Center for Advancing Translational Sciences