I have attended dozens of conferences focused on the clinical trial industry. A few months ago, our VP of Media, Kevin Hartbarger, suggested I consider attending the Consumer Electronics Show (CES) since the health technology tracks have become well-attended and would be relevant for clinical trial enrollment. So, with an open mind and no expectations I joined some 200,000 others for a few days in Las Vegas.
At the highest level, what made this experience more impactful than other industry meetings (like DIA and SCOPE) was its fast-paced, polished presentations and presenters who excelled at storytelling (à la Ted Talks). Clinical trial industry meetings are full of text- and data-heavy slides that illustrate past success; CES presentations focused on what is possible in the future.
We are on the verge of a tidal wave of change, driven by patients whose expectations will undoubtedly push drug developers to change—or become irrelevant.
As someone who thrives in creative and open-minded environments, learning about technology that will change the entire healthcare experience and the speed in which these changes are likely to happen, forced me to challenge every aspect of clinical development that I have known for nearly 20 years. We are on the verge of a tidal wave of change, driven by patients whose expectations will undoubtedly push drug developers to change—or become irrelevant.
To my surprise, patient recruitment in clinical trials, and the challenges and costs associated with delays as a result, were mentioned in half of the presentations within the digital health summit track. And when trial enrollment wasn’t directly referenced, the learnings were applicable. The tech sector may not have the experience or complete understanding of all the dynamics that make trial enrollment so complex, but they certainly understand the issue, the implications, and what the new consumer will be looking for as health-tech hits high gear.
The overall theme of CES, across the entire conference in all industries, was 5G. In a manner of months, 5G will be rolled out across cellular networks throughout the globe. Depending on your carrier, that speed could range from 20-100x faster than what you currently have. But the big deal is not the speed itself—it’s what the speed enables. Below is a summary of what I think Pharma should be paying attention to right now based on the looming emergence of 5G and its massive implications for clinical trials:
1. AI and Machine Learning: 5G will enable the trillions of data points that are collected every minute to be processed rapidly, accelerating and proving the effectiveness and intelligence of AI algorithms. And as AI and machine learning evolve, their application and adoption into the real world will result in rapid adaptation, and technologies like wearables, hearables, and sensors will just become an extension of our well-being.
So, what does it mean for clinical trials? With more advanced (and proven) AI, algorithms might be able to simulate and ultimately predict the likelihood of a study achieving its endpoint with less patient data than what is required today. This could significantly reduce the cost and exposure of development, increase the speed from lab to market, and ultimately cut drug prices.
2. Content: Bandwidth, load times, and screen formats are major considerations for content developers. 5G minimizes or removes some of those barriers, empowering developers to introduce new types of interactions for engagement. In a roundtable hosted by CNET, the SVP of Content, Services and Innovation for Samsung, Yoon Lee, gave a great illustration of a “new” type of interaction made possible with 5G: He plays in a band in California and has friends in bands in Korea. Today, the only way for them to jam would be to travel to one another. But with 5G and the right software, he could be playing alongside them virtually, in real-time, as if they were all in one room together.
So, what does it mean for clinical trials? This could transform the patient experience with virtual trials and tele-health as access and interaction with “virtual clinicians” will become more engaging, real, reliable and subsequently, more impactful. On the other hand, because the bar for content and user experience will be exponentially higher than what it is today, clinical trials will need to create more engaging and thoughtful ways to connect with and motivate patients.
3. IoT (Internet of Things): By 2025, there will be more than 75 billion connected devices, according to a recent Statista IoT forecasting report. The smart home is here to stay and just about every single company on the planet, including every major consumer company, is developing products that are WiFi enabled and/or integrate with virtual assistants and home automation systems (I’ll get to that next). From smart crockpots that enable you to cook from your office to razors that suggest the optimal time to shave – everything is connected.
So, what does it mean for clinical trials? This will transform how patients interact with your trial, opening up new opportunities for connected devices, wearables and diaries, that could and should improve the amount of data and information shared between doctor and patient. It also opens up the possibility for a new frontier of retention strategies to elevate patient experience and engagement.
4. Voice Activation: With everything “connected” and the power of AI, your voice will be able to control every device in your life—anywhere, at any time. There was a lot of discussion to move away from the “swiping” experience we all know to an experience that interacts intuitively with our voice. Further, there is recognition that the type of voice that you interact with is critical, as people will respond differently depending on the demographic and ethnicity of the voice (or voices) versus a single, one-size-fits-all voice. The rapid adoption of Waze is a great example of the power of voice, as it helped differentiate the app from other GPS providers by giving users the option to change the voice of the turn-by-turn navigation.
So, what does it mean for clinical trials? Voice activation of the IoT is set to truly transform the patient experience. Imagine the possibilities with voice-activated diaries with easy and timely prompts from Alexa, to instant access to study coordinators and PI’s, patient transportation on command, and more.
5. Technology as the Medication: The FDA is poised to soon review a submission for what will be its first approved “digital medicine”: a mobile video game treatment for ADHA from Boston-based Akili Interactive. Tech is everywhere: with the data and machine learning collected from sensors placed in your clothes (or even ingested), smart technologies will understand and predict your chemistry and behaviors. Technology will help people understand behavioral and chronic conditions in futuristic ways that have never been more tangible. For instance, using data collected from brainwaves, we’ll know what triggers addiction and we’ll be able detect (and potentially intervene) before an addict reaches for a drink. We’ll be able to pinpoint when someone with depression or bipolar disorder experiences an episode, or potentially even help an autistic child improve their processing.
So, what does it mean for clinical trials? The possibilities are truly endless – and it could be the dawn of new and widespread era of combo trials that evaluate the impact of technology + drug.
6. Privacy: The underlying subtext to every presentation was privacy. How do we keep all of this information protected, secure, and create governance so that it isn’t used to do harm? The acceleration of technology will answer questions that have perplexed scientists about our genome, DNA, the brain, etc. So, how do we prevent a Game of Thrones enthusiast from creating actual fire-breathing dragons, or someone from hacking Alexa and turning devices against their owners? (Yes, this feels like Terminator 2 kind of stuff.) Equally present was the theme that suggested a tech user (referred to in this context as “data donors” or “data dealers”) could and should be able to profit from their own data if they wanted to, especially if it’s going to be used to power machine learning and other advancements that companies will profit from.
So, what does it mean for clinical trials? This will undoubtedly be amongst the greatest barriers to the adoption of new technology in clinical research. There is nothing more important than keeping clinical data safe, protected, and pure—and there are no exceptions. How will pharma react if patient simply won’t accept an experience that is no longer relevant in the world? And what will Pharma regulators and legal teams do to prepare for the rapid change that is looming?
In the end, however, we’re still at a crossroads. It’s been almost 15 years since the Bush administration implemented its initiative to shift the country to electronic health records and we’re still not there. It seems almost ludicrous to be talking about driverless cars when we can’t even get off paper records. Nonetheless, this may be another example of change driven by consumers versus industry.
Ride sharing is a great example of an industry transformed by consumers. When Lyft and Uber burst onto the scene (as a point of reference, the Lyft app was launched 7 years ago) disrupting transportation, it was embraced by consumers but brought anger and fear to cab drivers who spent thousands of dollars to buy a medallion that gave them the right to drive and own their taxi. Consequently, the taxi industry fought hard to eliminate ride sharing across major cities, and in many instances were initially successful in doing so; but once consumers experienced this new transportation option, there was simply no going back. A new and better reality existed, and consumers demanded the right to choose. Today, ride sharing is a part of every major metro in the country and has become so embedded into life that 16-year-old kids who once counted down the days to get their driver’s license don’t even care because their perspective on transportation has fundamentally changed.
On June 29th, 2007, the first iPhone was released. Here we are—a little over 10 years later—not just talking about things that are possible, but the present future of humanity where machine learning, the Internet of Things, voice activation, and wearables are just ‘part of life’. What makes it so incredibly daunting is that each of us will be forced, like it or not, to live in this hyper-connected, 5G world that most of us don’t understand or relate to.
Change is coming. And if history tells us anything, this change will be driven by patients as consumers. So, you can either fight the change or embrace it. Either way, get ready!
