The traditional brick-and-mortar clinical research studies are getting a shakeup as digital comes onto the scene. The rapidly rising cost of clinical trials and the more recent coronavirus pandemic have put pressure on the industry to evolve.
“If you look at drug company trials, you see how much it is costing per participant. It is now at an exponential phase. It was unsustainable before and it is unsustainable now,” Dr. Mintu Turakhia, associate professor of medicine and executive director of the Center for Digital Health at Stanford University, said during a recent HIMSS20 Digital event. “We are actually seeing a lot of clinical trials break down due to enrollment, which can’t be done if the world is sheltering in place and if hospitals are diverting their resources for more acute things.”
What’s more is digital has the ability to unite the classical provider-care model and the research model – worlds that in the past spoke somewhat different languages.
“Consumer devices and technology more generally start to bring these together,” Dr. Jeff Kosowsky, general manager of strategic solutions and senior vice president of corporate development at American Well, said. “They facilitate connectivity, data capture and, most importantly, engagement that works equally well across that world.”
Today we have an increasing number of studies that have incorporated digital into their model. Perhaps one of the most notable digital clinical trials to date is one that Turakhia and his team at Stanford were involved in – the Apple Heart Study. The research is a collaboration between tech giant Apple, Stanford, American Well and BioTelemetry. The study was centered on Apple Watch’s role in detecting atrial fibrillation.
“The goal of this study was really to try to validate whether this could be used to identify those with atrial fibrillation and those without the disease, and to do this at scale, in a way that this would be opened, really out in the wild on a consumer-facing side not necessarily prescribed by a physician,” Turakhia said.
To date, the researchers have recruited 420,000 participants from across the U.S. Of those 25,000 are over the age of 65. The look and feel of this study are different from traditional trials. The initial onboarding process is done entirely online. Patients fill in their own medical history and demographic information. They even sign the consent forms on their phone.
Once a participant was on board, the algorithm would run in the background of their watch. If the algorithm detected and irregularity and pulse consistent with AFib, they would get a notification and be able to see a doctor through American Well's technology.
“This was a direct 'press a button and get into the cue' for a study visit with a doctor from American Well, and that was really what was so remarkable here,” Turakhia said. “So, no sites, no brick-and-mortar anything, no research nurses that you had to call at your local hospital. Everything was fully virtualized.”
But researchers had to preempt different issues that could arise in a digital trial.
“We had to be prepared for scale here. That isn’t just the app and the app store. The digital side is very easy to scale, but you had to be prepared to handle a massive intake of study visits and demand,” he said. “What if a whole bunch of people had AFib all along and day one of enrollment all got the notification and all called American Well? So, we had to build for exceptions and scale, which we did.”
While researchers were prepared to scale, there were also several lessons to be learned throughout the process that the partners are still addressing. In the study, around 2,200 participants got notifications about possible AFib. However, only 945 of those participants followed up with a study visit.
“On one hand, that is great. We had almost 1,000 study visits. On the other hand, we had significant attrition and loss of engagement,” Turakhia said.” So why was that? What can we improve? How can we make this more frictionless and study participants more adherent to procedures? It’s not like we have a study nurse at a local hospital that you know, and have a relationship with – and can call them. So, there is a lot here to learn.”
Turakhia said that while digital may be the next avenue in clinical trials, it’s a very different beast that the traditional in person ones.
“Virtualizing a tech trial is complicated,” he said. “It is fundamentally different. It is not like taking a piece of paper and digitizing it with a computer version. You need different bones from the start. The other thing we often do in clinical trials that requires high touch is exception processing. There are always going to be outliers and unusual conditions. You have to be able to virtualize the exceptions.”
Another major topic, which researchers of the Apple Heart Study did anticipate, was privacy standards.
“The concept of citizen science is all based on trust. So, you need to have a very good data flow and compliance, but a very high level of security that is conveyed to your constituency.”
At the end of the day, having a digital study had its benefits.
“I think that tech-enabled trials offer a lot of advantages in speed and efficiency – and scale. We’ve come to the point where we have figured out the tech; we’ve figured out the ops; and we know how to do this in a safe way,” Turakhia said. “With American Well we were able to have a system in place where their trained physicians could assess with protocol- and study-evaluation whether someone had a life-threating issue and could be routed to emergency care. We did well, and it showed we could use this across a variety of disease areas.”
Researchers and stakeholders are still learning. The Apple Heart Study gave them new challenges to examine and address in the future.
“The challenges are engagement. It’s not easy to do this. It’s not easy to keep patients involved. You can’t keep sending them notifications and push alerts to remind them to do this in the study. So how do we incentivize them? How do we do this in a way that makes sense, but in a way that is generalizable? These are issues with measurement validity and outcomes. What do you do with all those non-engaged patients with missing data, and how do you ensure end-to-end success? … We believe it is really critical to have experienced academic and operational partners.”
