- When Apple launched its ResearchKit platform in 2015, healthcare providers and the pharma industry hailed the mHealth platform as a meaningful step toward better clinical trials.
They’re starting to see that pay off.
Digital health tools have the potential to take “a big chunk” of the $3 billion clinical trial market, says John Dwyer Jr., president of the Global Alzheimer’s Platform Foundation. Not only can they streamline the trial process and open it up to larger populations, but they can also help providers and pharma companies make sure the right drug gets to the right patient.
Speaking at Partners Healthcare’s Connected Health Symposium this week in Boston, Dwyer – whose portfolio includes launching the mHealth diabetes company Telcare – used Alzheimer’s as an example. The disease affects some 5.4 million Americans each year, or one in nine seniors, and is the 6th leading cause of death. Financially, it costs the U.S. healthcare system some $236 billion in 2016, while forcing families to spend more than $5,000 a year in caregiving costs.
No new treatment for Alzheimer’s has been OK’d by the U.S. Food and Drug Administration since 2002, Dwyer said – and yet there are at least 100 drugs in the trial phase.
“The pipeline has never been as rich as it is today,” he said.
The problem? To recruit 4,500 participants for a randomized trial, researchers need to canvass some 7 million people to find candidates who meet all the conditions – diagnosed with Alzheimer’s, relatively healthy, not having a pacemaker or requiring insulin injections. That pushes the price tag into hundreds of thousands of dollars (if not millions) before the trial even begins.
Using a digital health platform, however, researchers could reach out to potential candidates around the country, even the world. Furthermore, using digital health tools and a telehealth platform, they could monitor trial participants in their own homes and communities.
The implications go well beyond Alzheimer’s research.
The clinical trial process “is an area where there (are) a lot of tremendous opportunities” for digital health, says Aaron Nelson, a general partner in dRx Capital, a relatively new venture fund looking closely at the space. Speaking during a panel session of pharma and mHealth experts, he said such a platform can replace “a whole set of steps” in the trial process that are cumbersome, slow and expensive.
But that’s not all. Cris De Luca, digital health innovation leader for Johnson & Johnson, says these new tools and platforms give researchers and clinicians a chance to dig deeper, gathering data from consumer engagement and new feedback loops to move away from the “medication guessing game” and toward “disease interception.”
In that setting, pharma and providers are realizing that they have to pay more attention to the patient.
Faced with more control over their healthcare choices and increasing deductibles, consumers are putting pressure on both providers and pharma to give them treatments that work, says Atul Singh, director of digital health for Walgreens. And with that movement toward value, they’re using digital tools to measure efficacy, or “validating the molecule.”
They’re also looking for ways to work with patients. Naomi Fried, former chief innovation officer at Boston Children’s Hospital who’s now a digital health and innovation thought leader, sees a trend toward “digital therapy,” or treatment plans that go beyond just the medication to include health and wellness coaching and remote monitoring.
“There’s so much more than just something that was made in a lab,” she said.
While all that may be in the future, little of it is in the present. David O’Reilly, chief product officer for Proteus Digital Health, the developer of a groundbreaking ingestible sensor, said pharma is still mired in traditional value prospects, much like healthcare providers who are still focusing on volume-based care models. Profits and regulation are focused on the traditional way of doing things, he said.
“There’s a disincentive for pharma not to explore beyond the pill,” said Singh.
Added Nelson: “Disrupting healthcare is not a technology issue; it’s a business issue.”
Fried says the evolution to digital health will be slow. “Truly disruptive innovation requires a new ecosystem,” she pointed out. But the signs are there that the industry is evolving. The success of Apple’s ResearchKit (and its Android-based cousin, ResearchStack) offers proof.
“It’s not in the DNA (for pharma) to engage with the patient, but they are taking those steps,” said Singh.