Dr. Know

Nearly every teenager has experienced the struggle of acne. While many cases can be treated by over-the-counter cleansers and washes, some can’t. Left untreated the condition can not only be painful, but can lead to cysts and leave behind permanent facial scars. For nearly 30 years, those who needed treatment for severe acne had an option with the drug Accutane.

Accutane hit the U.S. market in 1982 and became a wonder drug prescribed to millions of Americans. But by the early 2000s, horror stories that linked the drug to suicide, Crohn’s disease, and birth defects had emerged. Thousands of personal injury lawsuits were brought against Accutane’s manufacturer, Roche, which resulted in more than $50 million in payouts. In 2009, nearly 30 years after Accutane was first introduced and subsequently used by 16 million people worldwide, Roche stopped manufacturing the drug and withdrew it from shelves in a voluntary recall.

Though the U.S. Food and Drug Administration never issued its own recall and some generic versions of the acne drug still exist, Accutane is just one example of a medication to have hit the market only to be pulled after being linked to serious side effects.

Had those side effects been discovered early on, it’s possible that the drug might not have made it to market. Now, as technology becomes more integrated with the drug development process, real-time clinical trial data provided by the Internet of Things could prevent similar cases in the future—changing people’s lives in the process.

Making an Early Impact

Throughout the health care industry, a shift from doctor’s office visits to remote check-ups with physicians in the comfort of patients’ homes is under way. Services such as HealthTap and Doctor On Demand are becoming more common, making it easier for patients and doctors to connect. Meanwhile remote monitoring devices that track patients’ biometric data, such as wearable sensors like VitalConnect’s VitalPatch or MC10’s BioStamp, both of which are Flex partners, can provide an always-on conduit to help medical professionals make informed decisions.

Research studies and clinical trials that explore whether medical strategies, treatments, or devices are safe for humans represent a huge opportunity for the IoT, according to Dr. Kal Patel, senior vice president of Digital Health at Flex. “Today, virtually everything is manual, including the disclosures you have to sign,” he says. “But imagine someone participating in a clinical trial with a new drug and instead of having to go to the clinic every week to get basic vitals taken, this could be done with a remote monitoring device such as a VitalPatch or an MC10 patch.”

By gathering data constantly in this way, Dr. Patel explains, the clinical trial process improves because there is a reduced need for participants to regularly visit the clinic for check-ups. Instead of asking chronic obstructive pulmonary disease (COPD) patients to come in to perform progress tests as part of a new treatment, for example, they could do some of them, such as a six-minute walk test, in their own homes. Dr. Patel points out that the technology also allows the professionals who track patient responses to gather much richer real-world data. This compiled data can reveal quantifiable progressions, especially for chronic-condition patients who may not notice subtle deteriorations or improvements over long periods of time.

MC10’s wearable BioStamp sensors gather information from the body parts to which they are affixed, allowing researchers to collate the data quickly and filter it to see what factors may be most applicable to their studies. MC10’s sensors are currently being used by some of the top pharmaceutical companies in the United States as part of early clinical trials. At the same time, VitalConnect’s wearable patches are designed to be placed over the heart, relaying vital signs and biometric data to the cloud for doctors and physicians to access securely. “So how can we improve safety monitoring on high-risk drugs?” Dr. Patel asks. “How do you use wearables or other types of tests to determine if somebody is at risk for a catastrophic side effect and head it off?”

Looking to the Future

In ongoing clinical trials, humans remain the participants even though technological breakthroughs have brought us closer to the so-called lab on a chip—a miniature device consisting of a computer chip that mimics a cell’s reaction to treatment and is used for research and clinical applications at extremely low prices, possibly eliminating the need for human test subjects in the long run. Until then, keeping human test subjects safe is paramount and therefore ensures the safety of future treatment recipients.

Another challenge with clinical trials is that they often rely on data from small groups of patients that are spread across hundreds of sites all over the country. The lag time in gathering and analyzing all that data could delay the discovery of a safety issue that shuts down the whole trial, Dr. Patel points out. But if each trial patient is on a connected platform, the data could be relayed and analyzed more quickly for red flags. This makes it possible to eliminate the drugs and devices that aren’t going to work in a way that’s faster and potentially cheaper, Dr. Patel says. “Hopefully you find the winners, and bring them to market faster and with more robust data supporting them than you have today.”

Making clinical trials more effective could rapidly bring life-changing drugs and treatments to patients who need them most. It could also help prevent potentially dangerous or ineffectual drugs from reaching more clinical trial participants, Dr. Patel notes. The IoT might even be able to stop recalls from happening in the future.

Dr. Patel says that eventually the electronic records that store information from these remote monitoring devices may work with new algorithms that can identify the most underdiagnosed and undertreated patients, preventing those at risk from falling through the cracks.

So does that mean we’ll all be walking around with patches or devices on our bodies that transmit our vital signs over Wi-Fi and cellular networks, storing the data for our physicians? Don’t count it out, Dr. Patel says. “Over time, just like how almost everyone has a smartphone today, the value proposition becomes clearer and clearer,” he says. “We’ve got to get to the point where everyone wears them. I’d wear a patch every day if you can prove to me why it would be extremely valuable to do that.”