Destructive Automation: Coming Soon To A Clinic Near You!

By Ed Miseta, Chief Editor, Clinical Leader

Today it seems everyone has something they want to change about clinical trials. Whether it is to reduce the costs, increase efficiencies, take advantage of new and improved technologies, or better engage patients, there is no question people would like to see needed changes implemented.

As firms look at their capabilities and the newer technologies that have the potential to transform trials, mHealth is probably at the top of the list. More than anything else, mHealth has the potential to dramatically transform clinical trials by recruiting and retaining patients in ways that have never been done in the past, while increasing efficiency and reducing cost at the same time.  

When explaining the benefits mHealth can have on clinical trials and life sciences in general, Glen de Vries, Medidata’s president and the keynote speaker at the recent MCT-Congress conference in Edinburgh, likes to use the six-minute walk to illustrate his point. The walk is a simple test used to measure a person’s mobility and activity level. The test is widely used and a well-understood end point. Although it is a relatively simple test, some might question using a walk up and down a hallway as a proxy for how active a person can be in their life. Additionally, the individual would have to then be seen by a physician post-test, since the patient would not be able to provide a subjective measure of their capabilities.

“In today’s world, that sort of test seems to be almost archaic,” says de Vries. “With the devices we have available today, we can measure how much a patient is moving, and use that data to instrument the patient in more sophisticated ways than we ever could in the past. Best of all, it can be done with a device carried in their pocket or worn on their wrist, along with a smartphone or tablet they likely already own.”  

De Vries believes the impact technologies like this can have on clinical trials is unlimited. The technology will certainly lead to a better understanding of efficacy and safety, which will in turn lead to better outcomes for patients. There will also be a huge financial impact on the industry by simplifying the entire process. An untrained patient wearing a device or carrying one with them can replace the necessity of having tests or readings performed at a clinic by highly skilled doctors, nurses, and other healthcare professionals.  

Bring Destructive Automation To The Clinic

Glen de Vries, president, Medidata

What technology can allow us to do in the clinical environment is take activities that require skilled labor and put them into the hands of the actual patient. This will result in less work needing to be performed by the clinic, a lower cost for the sponsor, and ultimately a lower price for the end user. This process is what de Vries refers to as destructive automation.                 

“Our goal should be allowing patients to gather as much data themselves as technology will permit, so as to allow the clinical sites to focus on higher value tasks with the patient, or even have time to see more patients,” says de Vries. “Either way, the end result will be a lower-cost clinical trial along with improved scientific data, which is something everyone in the industry is striving to achieve.”

By implementing available technologies in new and novel ways, de Vries believes we will possess the ability to measure how patients are responding to therapies in more detailed and sophisticated ways. 

To illustrate this point, de Vries points to white coat hypertension, a situation where the nervousness of a patient causes their pulse or blood pressure to be higher when in from of a doctor or nurse than it would be had it been recorded at home.  It’s a physiologic effect, but is a real effect nevertheless, and has to do with how the patient is feeling and the environment they are in.

“In clinical labs we perform randomized controlled trials, and one of the reasons for that is the placebo effect,” he says. “This is also a real effect with physiological change occurring in patients who think they might be receiving an actual drug when all they are receiving is a sugar pill. Now relate that back to the six-minute walk test. How do we know that there’s not a six-minute white coat walk test? How do we know that patient is not walking faster or slower because they are in front of a doctor? How do we know their pulse or stress factor is not higher or lower because they are in front of that physician?”

Will Everything Else Be Held Constant?

Back in college, whenever my economics professor mentioned a law, he would end it by saying Ceteris Paribus, a Latin term essentially meaning “all other things held constant.” Letting patients record data at home might eliminate white coat hypertension, but could lead to other unexpected outcomes if other external factors are involved. For example, someone could be nervous over an upcoming date, a family pet could jump on you while you’re recording data, or maybe you were running late and just sprinted into the house.

While acknowledging that a number of factors could aggravate a patient, de Vries notes that because of the size of the data sample collected, clinics would be able to mathematically eliminate or account for aberrations. But another way to prevent bad data from being collected is to properly educate patients. If a patient is taking an ECG at home, they should know they need to be sitting, they should be calm, and that there should be no drama in the room that could affect the outcome. With the technology available, clinics will also be able to detect if a test has not been administered properly by the patient.

There is another factor at work here as well, which also relates to the technology. If a patient needs a full ECG, they can now attach a device to their body that looks like a Band-Aid. It works for three days and constantly takes a two-lead ECG reading. Data is streamed by Bluetooth to a smart phone and is then uploaded to a cloud platform. At that point a medical monitor can read and review the data and perform processing on it. Depending on the patient and their activities, there may be many times when the data is accurate and of good quality, and there will be many times when it isn’t.

“We will have access to that reading every minute of every day for those three days,” says de Vries. In cases like that, we don’t need to worry about the patient or their training. In fact, we’ll actually know what that patient’s heart rate is on average, not on average at the various times when they or their doctor opted to measure and record it.” 

Furthermore, technology will soon be able to assist doctors in monitoring for potential adverse events. In a typical clinical trial, if there is a serious adverse event, such as a heart attack, the patient will be rushed to the hospital. Historically, clinics have tended to be reactive to those types of events. However, we are moving into an era of data-driven, participatory medicine. Wearable devices can monitor the health of study participants and capture data that warns doctors of a potential risk—such as a heart attack—in advance, helping them get patients the care they need more quickly.  

New Technologies Make It All Possible

While this proactive approach to adverse events in patients may have been a dream just a few years ago, new technologies are making the approach more of a reality. Fifteen years ago no one was familiar with the term “bring your own device.” Clinics would not have been able to recruit patients with their own smart phones and tablets. Today, if you look at the clinical trial market in terms of connecting directly with patients, we do live in a world where a bring-your-own-device strategy is possible.  

To collect data and push it via Bluetooth to a smart phone and eventually to the cloud, we first need for patients to have a smart phone. Today, the necessary infrastructure exists and most patients have a smart phone. The number that do not have one will be lower tomorrow than it is today, and will likely be lower every day going forward. The day will come when de Vries believes we won’t even have to think about it anymore.  

The instruments continue to get better as well, and we have wonderful device manufacturers to thank for that. “Today we are seeing an absolute explosion in the functionality that can be accessed on mobile devices,” notes de Vries. “There are more companies building these devices, and the technologies work well, require no training, have great battery life, are easy to deploy in the field. All of these factors will continue to drive their acceptance in the clinical space.”

There will certainly be issues to deal with along the way. What happens if a patient forgets to turn on their device, or the battery dies, or the patient leaves the house forgets to wear it? In those cases, de Vries notes the device will stop streaming data, or will stream a set of zeroes up to the cloud. When that happens, a phone call can rectify the situation. New devices may also come along that can make having the technology with you at all times an easier endeavor.

“Technology will keep increasing, devices will continue to get smaller, and devices will continue to get easier to handle,” says de Vries. “If tomorrow were to bring an iWatch with health apps, a user friendly interface, and a battery that lasts a year, most of these concerns will be instantly alleviated. Consumers are quick adopters of the latest technologies, and I don’t expect that to change.  What remains to be seen is whether pharmaceutical companies and CROs will be as quick to adopt the technology as their patients.”