The evidence base for mobile health and remote based monitoring (RBM) has been lacking, thus there has been a lack of acceptance by clinicians. Additionally, the number of wide spread deployments have been few, and mostly to treat chronic patients.
“Trust hasn’t been 100%,” Greg Caressi, Senior VP of Transformational Health for Frost and Sullivan, tells OutsourcingPharma.com. Yet, as the technology has improved and the number of companies building remote monitoring tools increases, that clinical doubt is slowly being overcome.
According to Caressi, another reason RBM hasn’t seen widespread adoption is simply due to inertia.
“If my companies not demanding it, why do I spend money on it?” he asks, noting that this attitude is generally true to industry as a whole.
However, according to new analysis from Frost & Sullivan, the US remote patient monitoring market is expected to reach a compound annual growth rate of 13.2 percent through 2020.
James Prutow, Advisory Partner, PwC, tells us that the CRO industry is “going ahead and getting greater connectivity to the patients in who are in trials” – and it’s time.
“Every industry is slow to change,” adds Caressi, Senior VP of Transformational Health for Frost and Sullivan. “Pharma is definitely one of them and clinical trials have been behind the curve in adopting technology.”
Why now?
According to Caressi, there are several benefits to adopting remote monitoring tools, all of which result from an increased accessibility to data.
Specifically, having access to data earlier in the process allows researchers to react more quickly to data coming in, and to identify patterns as they form. In turn, this allows a trial to be discontinued at the earliest point possible, if need be. “This is a big cost savings in the end,” adds Caressi.
Conversely, remote monitoring tools would allow other trials to stay up and running longer.
To explain, Caressi shares a general rule of thumb: if a trial site is more than a half hour away, the follow-through rate with participants in very low, leaving researchers without enough data.
In short, convenience is key.
With RBM, “[researchers will] see less drop outs and create more valid data and save money on trials that aren’t stopped because of people dropping out,” adds Caressi.
Additional costs savings will also come from shortening start-up times. “Widening that pool [of participants] creates a lot more value not just in the validity of the data but in the ability to more quickly recruit and from a wider patient pool,” explains Caressi.
A wider patient pools also plays to the continuing trend of being able to provide global trial capabilities.
Ultimately, “the reality is you are going to get more accurate data.”
A competitive advantage
When asked how the emergence of RBM will affect the industry, Caressi says, “I think it’s going to evolve and become a competitive advantage.”
This advantage will come to companies integrating remote monitoring tools.
For example, Quintiles has been busy working with Apple’s ResearchKit, and in November of last year signed an agreement with Validic (a technology platform company).
“I think you’re going to see deals like this that create a competitive advance for a company like Quintiles,” says Caressi, “in that they’re all going to have to revise IT structure.”
“Over time, CROs will have to migrate to a more open IT structure,” he adds.
Other examples include Propeller Health partnering with GlaxoSmithKline to produce sensors for the company’s dry powder inhaler. The digital health collaboration will help Propeller automatically monitor patient’s use, including dates and times.
Dave Allen, GSK Senior Vice President of Respiratory R&D says:
“We continue to find new and better ways to conduct clinical trials by exploring novel patient centered outcomes through strategic collaborations. Using innovative sensor technology to improve the quality of adherence data collected during our studies will advance our understanding of disease and inform our decision-making in the development of new medicines.”
The migration
There are certain types of tests that can’t be done remotely, “but this will also change over time,” Caressi assures us.
For example, while blood can’t currently be collected remotely there has been activity in developing an acceptable solution – and a solution may be seen within the next five years.
On the diagnostics side, many of these tools are already being used, as many patients can now complete various tests in the comfort of their own home.
Yet, to be used in a clinical trial setting, testing and validation needs to occur in order for the technology to be implemented.
Ultimately, RBM still faces limits.
“[Remote based monitoring] doesn’t change every trial and every protocol,” explains Caressi. “But once it starts being implemented you’ll see companies be more creative in how they’re using tools.”
“Things will change,” he adds, but “you can’t turn the whole industry upside down.”