Clinical Trials, Millennial Style

Before Fitbits were fashionable and kids counted steps at recess, Rob Scott, M.D., AbbVie’s chief medical officer and vice president of development, knew the power of digital health. For 20 years, he has been digitally logging every workout, charting and graphing every bike, swim and run. And while digital health has forever changed the way he and millions of others stay healthy, Scott says the real power of digital health is how, by revolutionizing clinical trials, it can help people who are sick get better.

The very first known controlled clinical trial was conducted by James Lind in 1747 aboard a naval ship, when he showed that oranges and lemons were a cure for scurvy. Ideas like placebos, double blind trials and randomized trials came later, but essentially the clinical trial of 1946 is the same clinical trial we use today.

But it’s not the clinical trial of tomorrow, according to Scott.

We sat down with Scott to hear his thoughts on how digital health will change everything when it comes to clinical trials, from recruitment to helping patients navigate their own trial experience, to collecting better and more accurate data from the trials themselves.
 

Rob Scott, M.D.: Well, according to the U.S Food and Drug Administration (FDA), digital health could be mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. Those are all technical definitions. To me, it’s the power of personal data to improve quality of life. Whether we are talking about skin patches to determine body temperature, wearables to track seizures or sensors that measure the quality of a night’s sleep, digital health technology can provide insight into a person’s health today and even provide clues to future health issues. All of this information is empowering both those participating in clinical trials and those who could benefit from these trials in the future.

Scott: The data that we can collect today goes way beyond steps and heart rate. Wearables can uncover patterns as to why someone is sleeping more or being less active on days that a medication dose is missed. Here’s another example: the primary endpoint in rheumatoid arthritis studies is often something called an ACR score, which counts the number of painful and swollen joints to determine if the disease is getting better or worse. But this score doesn’t mean a lot to patients. What makes their day better is when they can get out of bed in the morning and get moving, or if they can tie their own shoes. Both of these events can be measured digitally with minimal effort by the patient or physician and can be included in clinical trials.
 

Scott: Absolutely. For example, we asked eczema patients to wear a wrist monitor at night while they were sleeping to measure the frequency and duration of “nocturnal scratching.” These patients are often unaware of how much scratching disrupts their sleep, but interrupted sleep is linked to severe health issues. We found that we could capture very robust data about how a treatment was working by doing this in just a few patients, and patients didn’t have travel to a clinical trial site for a formal sleep study. We captured this data remotely with 24-hour tech support.

Scott: Two out of three patients who would like to participate in a clinical trial can’t, because they don’t live close enough to a research site. This also impacts the speed at which we can bring new therapies to patients. By the use of virtual clinical trial sites that collect data with wearables 24 hours a day, we can extend the opportunity to participate to more patients and conduct better studies.
 

Scott: In five years, I expect every clinical trial will incorporate some type of digital health element. Whether it is heart rate, body weight or sleep, we’ve grown accustomed to immediately accessing real-time personal health metrics that can improve the accuracy and speed of clinical trials, helping us get new medicines to patients faster.

However, we are just scratching the surface of how much data can be collected with very minimal effort. In 10 years, we will see a lot of the manual work in clinical trials being automated, allowing us to do more with less. Right now, we have implemented a few isolated digital initiatives. I liken it to the banking industry in the 1980s, when everyone had a few ATMs where people drew cash, but most of the work was still being done using paper and pen in a branch office. People could not imagine that they would be carrying what amounts to their own branch office, on a phone, in their pocket. In 2018, we have the advantage of being able to imagine how to carry an entire clinical trial site and a laboratory the same way.

Scott: We realize that the new digital clinical trial world is a very different place from where our clinicians grew up in the past. It is evolving at light speed, and needs someone working in the space five days a week to keep up with the pace. There are so many new opportunities as well as potential pitfalls to avoid, and we need to provide teams with expert guidance if we want to maximize our success.

To that end, we recently opened a new Design Lab featuring a database that includes 14,000 clinical trials and 32 million clinical trial participants, along with real-world data from electronic medical records of hundreds of millions of patients. Using the latest immersion technology, including rooms with touch pad screens that take up entire walls, we hope to bring the movie “The Minority Report” to clinical trial design by giving our teams the ability to predict the future. Our Head of Digital Health works with these teams when they come to the Design Lab to incorporate digital options into trials in the best way possible. It’s something we consider with every single clinical trial. I have a quote on my whiteboard: “You can’t do today’s job with yesterday’s methods and be successful tomorrow.”