One of the first things that may blow your mind when you talk with Adam Hanina, WG’07, is that advanced pharmaceutical clinical trials do not check whether or not subjects are actually taking the experimental drug. Sure, they ask for the return of empty blister packs, and they periodically test blood levels. But it’s far from an exact science in an area of medicine where one simply assumes rigor is always prescribed, and where as few as five cheaters out of 200 can kill a $25 million drug trial. That failure of measurement might help explain why there were $8.6 billion in settlements from 2009 to 2011 in the U.S. alone against pharmaceutical firms for launching purportedly unsafe meds.
This is not to imply that clinical researchers don’t care to do the right thing. They simply do not possess the technology to confirm outpatient behavior. And complying with a medicine regime—whether experimental or simply a person’s everyday scripts—is all about behavior. Behavior explains why any of us remember to take our prescriptions for heart disease, mental illness, diabetes, you name it.
As someone who has been in health care for 16 years, Hanina believes that the key to change is influencing that patient behavior, and that technology and software in particular are ideal tools—and thus the keys to nothing short of “clinical trial transformation.” He’s bet the last five years of his life on this, with a New York-based artificial intelligence company called AiCure.
His particular agent of change is something that many Wharton entrepreneurs have and are working on for many other reasons: the mobile app. And whether it’s to effect a health care revolution or to attract the next generation of gamers, apps work because they tap into a device that’s already wildly popular for personal reasons. About 2 billion smartphones are in the hands of consumers today, and by 2018, that number could reach 5 billion.
Watch the AiCure technology in action in the above video.
Beyond this inherent popularity, smartphones and their apps allow unprecedented access to people’s lives. Or to be blunt: “What used to be considered big brother is now viewed as completely normal” Hanina says.
The AiCure technology works by using facial recognition and motion-sensing technology to automatically monitor patient behavior through the smartphone’s webcam—by confirming the patient’s identity, the pill’s identity and that the patient fully ingested it. Usually, health care workers watch patients directly taking their medication in the early (Phase 1) stages of a clinical trial. Once patients are enrolled in later phases of a trial, however, they take their medication at home; no reliable way exists of knowing what patients are doing. By automating this process, health care workers can remotely monitor large patient populations and intervene when necessary.
Involving patients in the process and making both sides feel accountable for adherence “has the potential to transform clinical trials,” says Hanina.
It’s a concept that appears to be perfectly poised to disrupt current practices, and it’s welcome. The National Institutes of Health has funded AiCure with $3.4 million in the past two years. AiCure is partnering with a number of global pharmaceutical clients and major academic centers and working with stroke, bipolar and schizophrenia patients. In the schizophrenia clinical trial, the tool has so far tested at a 76.4 percent adherence rate, far higher than the average 50 percent adherence rate typically seen, Hanina says. AiCure has also initiated a major substance abuse study at the University of Cincinnati. And South Korea had been in touch to test the product on a population of 80,000 tuberculosis patients.
AiCure’s main competitor appears to be Proteus Digital Health, a firm that implants microchips on pills and has raised $400 million from investors. Hanina claims competitive advantage, however, in that his technology does not require alterations in the drug manufacturing process, which adds significant costs and hurdles to clinical trials, he explains.
Is it too optimistic for Hanina to believe he’s got a superior product than what is currently being used by the clinical trial market? Despite being a more “intense” monitoring solution, Hanina believes that his platform, which costs no more to pharma companies than the blister packs they currently use to “measure” compliance, could possibly be the answer by tapping into the billions of existing smartphones already out there—and in the process change how prescription treatments are tested and brought to market worldwide.