Stanford University researchers last week announced they had enrolled 400,000 patients in a clinical trial to test whether an app on the new Apple Watch can effectively screen for a heart-rhythm disorder.
The trial, dubbed the Apple Heart Study, is the largest atrial fibrillation study in history. And, whatever its findings — which are due to be released early next year — some clinical trials experts wonder whether those watches aren’t just ticking out time and heartbeats — what if they’re also tolling a warning to the industry that if it doesn’t shape up it could be swallowed up?
“The concern really is the people that own those relationships with the consumers. They’re the ones, really, who are going to drive that dialogue,” instead of traditional researchers, says Kent Thoelke, chief scientific officer at PRA Health Sciences, a CRO based in Raleigh, N.C.
“For us to continue to acquire patients in clinical trials, pharmas [and] biotechs are going to have to advance their willingness to include decentralized trials, mobile monitoring ...” he adds.
The difficulty is that few drug or biotech companies seem to be making those kinds of investments. And Thoelke says he’s concerned that the trials industry is at risk for what is sometimes lazily called “disruption” — big data companies, unaccustomed to traditional regulatory and business models of the trials industry, amassing customers (and their data) vital for trials.
Many with massive customer databases are already inching their way into the drug industry. For instance, the Apple Watch is in trials now. And just last week, the FDA gave limited approval to 23andme to offer consumers genetic testing to gauge how well they can handle some medicines.
Plus there’s Amazon and its 85 million Prime customers. Amazon is already working on a healthcare system of its own (and some financial analysts are urging the tech giant to move into clinical trials). That’s a veritable goldmine of data and patients. But if sponsors aren’t careful, they could find themselves locked out, Thoelke warns.
Already, for instance, nearly a quarter of millennials don’t have a primary care physician of their own, closing off a key trial recruiting source for traditional sponsors.
It’s not just Amazon or Apple. It’s about who “owns” the customer relationship —and, increasingly, it’s not the drug or biotech companies, Thoelke says.
Not everyone is as concerned as Thoelke. In fact, Norman Goldfarb, chairman of MAGI, says the entry of big tech into the trials arena may actually help the industry. He says that the emergence of companies like Apple and Amazon are merely making it easier for patients to control and access their own records, which opens the door for more data to flow into trials.
“There will be much more complete, much larger databases which is much more important for precision medicines. The smaller sites are terrific on quality and timeliness, but they don’t have big databases. This may give them that access,” he tells CenterWatch.
Thoelke stresses that he doesn’t think the end is near. He sees the current moment as an opportunity for drug sponsors and CROs to partner with big data companies. But they’ll have to move quickly, and rethink some of their approaches even more quickly.
For instance, patients are becoming less tolerant of traditional paper diaries and their expectations are being raised daily by gadgets or devices like the Apple Watch, which can amass reams of data seamlessly. Sponsors, CROs and sites need to come up with ways to capture that experience in trials — so it’s easier for patients to participate, Thoelke says.
“We have to figure out a way,” he says, “to blend the research into [patients’] everyday lives” the way, for instance, that an Apple Watch does.
-By Bill Myers