Donald Jones: The Transformative Impact of Digital Health on Clinical Trials

Innovation in internet healthcare will not proceed in a gradual, incremental manner, but rather through dramatic reimagining. This theme permeated the morning sessions of the Internet Healthcare Track at the 2015 BIO International Convention and Exhibition (BIO 2015), held in Philadelphia, USA, in mid-June. VCBeat has compiled highlights from the track’s presentations to showcase the transformative impact of internet healthcare on clinical trials.

“We are living in a disruptive era. Initially, people would say about the moon landing program, ‘This is absolutely crazy,’ and within a few years, it became commonplace,” said Jack Hidary, Chairman of Samba Energy and member of the Google X Laboratory Advisory Board. “If you search for ‘self-driving cars’ on Google and look at the results from seven or eight years ago, the coverage of this concept was along the lines of ‘This will never happen; it’s simply too crazy and too dangerous.’ Today, however, all major automotive companies worldwide are developing their own self-driving car technologies. We can use this technology to save millions of lives while also making our highways much better. I have experienced this firsthand and firmly believe that this once-disruptive idea can become mainstream in a short period of time.”

Donald Jones, former Global Vice President of Strategy at Qualcomm and current CEO of Trial Fusion and Chief Digital Officer at Scripps Health, stated that connected sensors will help facilitate a similar paradigm shift in healthcare. “Sensors will make significant advances in a short period,” he said. “Miniaturized sensors enable measurements in clinical settings, and they are also being manufactured as disposable devices for consumer use in various scenarios—whether as wearable or implantable devices. Many sensors are already commercially available or in the process of commercialization.”

Jones also stated that Scripps “broke many rules” in clinical trials. For instance, in a recently disclosed trial conducted in collaboration with Deepak Chopra, researchers generated extensive data for each patient, prompting Scripps to reconsider how physiological data should be structured. To achieve this goal, instead of collecting and analyzing all the data, they established individualized norms for each patient and then focused solely on identifying data points that deviated from these norms, investigating the causes of such deviations.

Jones also discussed a behavioral trial designed not for patients, but for cardiologists. The aim of the trial was to help Scripps identify which outcomes would drive providers to adopt internet-based medical technologies. This trial was sponsored by a major insurance company and a large pharmaceutical company.

“We leveraged internet technologies in our clinical trial and attempted to implement highly innovative designs, breaking as many conventional rules as possible,” said Jones. “In this trial, we recruited participants from patient claims data and engaged them through their insurance providers. These participants then helped recruit cardiologists. Of course, if a participant’s cardiologist declined to take part, we would assign an alternative cardiologist. The aim of the trial was to explore what types of information could change cardiologists’ behavior under current state-of-the-art technological conditions. Thus, it was essentially a behavioral trial focused on cardiologists. I cite this example because it defies every rule outlined in standard textbooks. Its starting point was highly novel: How can you encourage physicians without technical backgrounds to adopt technology-based treatments?”

Jones believes that partnerships like the one between MDLive and Walgreens have the potential to fundamentally transform the healthcare system. “Walgreens has successfully placed its app into the pockets of 35 million people,” he said. “Now, telemedicine features have been added to the app. When will telemedicine become the norm? When will remote physicians become the first point of contact rather than a substitute for in-person doctors? Is this because retailers like Walgreens have put such apps into the pockets of 35 million people? These are questions we still need to answer.”

Ultimately, if the goal of internet healthcare technology is to disrupt the healthcare industry in an extreme manner, traditional regulatory and reimbursement channels are more likely to hinder than help. Recent examples show that some companies are bypassing these traditional channels to demonstrate the efficacy of their technologies, thereby forcing regulators to catch up.

Jones then cited the example of Nightscout. Nightscout (CGM in the Cloud) is an open-source, do-it-yourself project developed by a group of hacker parents. It allows users to access Dexcom’s continuous glucose monitoring (CGM) data in real time via web browsers on smartphones, computers, and tablets, as well as on Pebble smartwatches. The project aims to enable users to remotely monitor blood glucose levels in Type 1 diabetes using existing monitoring devices. According to Jones, the U.S. Food and Drug Administration (FDA) contacted Dexcom, requesting that the company stop users from engaging in such hacking activities. “Fortunately, Dexcom users pushed back against the FDA, saying, ‘You can try to shut us down, but we will take our case to Congress and tell them how the FDA is preventing us from saving our children,’” Jones said. “The FDA then backed off. This is just a small example of how digitalization enables solutions to exist and evolve in a democratic manner.”

The same applies to the Tricorder X Prize. Jones stated that, rather than experiencing slow development in developed countries, he believes successful devices should be deployed first in developing nations, where regulatory barriers are lower. Regarding reimbursement, Jones does not believe digital health entrepreneurs should target the Centers for Medicare & Medicaid Services (CMS). “I think the reality is that in today’s U.S. market, you either need to establish a foothold in the consumer market or the self-insured employer market to secure reimbursement, or focus on high-risk populations within models such as Accountable Care Organizations (ACOs).”

“Moreover, you cannot blindly scale up until the risky portion of the payment structure is reduced to just 30%–40%. Otherwise, it will be highly fragmented.”

Further Reading ↓↓↓

Experts Call for It Is Time to Use Internet Healthcare in Clinical Trials

[Quick Read of Foreign Journals] Can the UK Regain Its Edge in Clinical Trials?

Compiled by Chen Xin | Edited by Mo Renying