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BYOD: Enabling Omni-Channel Success

Paul TaylorSenior Vice President, Patient Centric eCOA

Introduction & Purpose

Data is everything for a clinical trial. Patients are vital to study success and the collection of data. Failure to collect data can also be a deciding factor in a sponsor’s ability to release a new drug to market on time and ultimately serve the innovation of better health.

With the increasing complexities of launching clinical trials and the noisy vendor landscape (a total of 75 according to a report published by Research and Markets in July 2022) offering ePRO/eCOA solutions, there are many perspectives on how we can best serve the sites and patients to protect data capture as an absolute. Most companies offer a blend of provisioned and Bring Your Own Device (BYOD) strategies, and in some instances, companies that started as an EDC platform and evolved into capturing patient data have a web offering as well.

A Look Back

Since the release of the ePRO guidance in December 2009, there has been a consistently scaling adoption of electronic capture of site and patient data used in clinical trials (Shifman/Stone, 2002, Patient Non-Compliance in Paper Diaries)(1), positioning the ‘electronic’ part as vital to collecting objective evidence from a safety and efficacy perspective around targeted endpoints for all research.

Moreover, since the pandemic, increased acceptance of innovation and the age of the decentralized trial is pushing us all to think about how to reduce patient burden and optimize data collection success in new and innovative ways.

Still, even today, sponsors continue to be risk-averse as it relates to BYOD in clinical trials, depending on expensive provisioned devices (hardware/connectivity is still the #1 ticket item for ePRO trial operations today) and web backup solutions for <1% of data scenarios from the field requiring a temporary collection mechanism in the event of a patient ‘dropping their device’ down the toilet. Compliance and inclusion are everything, but what is the best experience for the user? Are we truly considering the patient experience when we deploy these modalities? After all, we’re trying to focus on getting therapies to patients faster, but is that really happening? First, a bit of history.

In 1996, there was a short craze from Japan—you probably all remember it. The Tamagotchi—a handheld digital pet, released by Bandai and then into the USA market in the early 2000s. Every kid had one, and they had to keep it alive. Most parents still have PTSD from the first time their 3-month-old digital pet died. You probably all remember the pre-iPhone era of the MP3 player—devices people carried to listen to compressed audio files on the move. Then, in 2008, an innovation happened that changed the world and did it all—the invention of the first Apple iPhone. How many of you carry an MP3 player today or have bought your kid a Tamagotchi since 2008? Exactly.

Where Does Adoption Stand Today?

Today, smartphones are the primary option when it comes to any phone purchase. As a result, smartphones are prevalent in every walk of life, invading our every moment of interaction, which, depending on your perspective, is both a good and a bad thing.

  • It’s good because there’s now a very common mechanism to reach anyone, anywhere. Expanding business opportunities and the potential for new life experiences for everyone.
  • It’s bad because we’ve somewhat evolved into "connected devices" ourselves, craving our next interaction or experience from our mobile device and forgetting what matters most—human interactions, enabled by the miracle that is life.

Exploring the smartphone saturation of the world today:

  • >7/10 people in the United States have an iOS or Android device, with outliers coming mainly from the elderly population who have chosen not to adopt email and mobile phone technologies. Owning a smartphone does not necessarily mean they are used smartly.
  • ~6/10 people in the People’s Republic of China have a mobile device—over 865m people.
  • And so on and so on….

So, when you think about it, easily over half of the world’s population today is using a compatible iOS or Android device in their everyday activities. Yet we continue to provision mobile devices to them and ask them to keep alive 'à la’ the Tamagotchi experience—why? To collect a few assessments they need to complete daily?

Why not do that from the same mobile device that offers them endless experiences for everything else? How many of you have a work phone and a personal phone? How many of you forget to take one of them to work? In research, collection of data is everything, and proven from recent SARS Cov2 trials, where large volumes of patients globally were recruited quickly to evaluate the safety and efficacy of vaccinations to get us back to the world, BYOD is real and it works.

Moreover, technology is becoming more reliable – iPhone and Android devices are now water resistant. They are drop-tested from significantly higher positions than their fragile predecessors that were not able to survive the fall. Consistently, you see less than 1% failure of hardware used for ePRO in clinical trials. So why do we continue to push provisioned devices and even awkward web modalities as backup when the obvious mechanism is right in front of our faces, invading our family time, and continuously driving consumer adoption worldwide?

I’ll tell you why—the world is afraid of change. Well, SarsCov2 proved to the world that there is a better way. Adopting BYOD during this time meant research was not only done faster, but it also saved millions ($) in hardware purchases, saw better compliance, and generated an accelerated market for an industry now projected to be worth well over $6bn by 2026.

Still, customers ask, ‘but why would we use BYOD for trials where there are primary and secondary endpoints? We need to protect our captured data.' Collection of endpoints is key to research, but when you look at protocols, how many of them have eCOA as a primary endpoint? What is it that we are protecting by enforcing a provisioned approach? BYOD facilitates the collection of data, and if the main barrier to adoption is non-compliance, well, with the power of the THREAD platform, you not only know where you are non-compliant due to technology and human behavior via our visual reporting and analytics platform, you also have the tools to direct communications to the participants near real-time via our push notification capability that is native to our participant app. No more dependencies to send compliance email alerts to sites and hope they chase down non-compliance matters with the patients. THREAD puts simple tools in the hands of coordinators to drive safety and efficacy in trials – irrespective of the device type in use with full deidentification to protect patient privacy.

Incorporating BYOD

So, when you’re deploying your eCOA solutions in the future, consider building BYOD into your study protocols, not only as a backup mechanism, but as a primary mechanism for success. When thinking about BYOD, go beyond the patient and include the site staff, enabling them to use their own work devices to interact with and manage patient interactions. In the rarest event that someone breaks or loses their phone, they will still be able to access an alternative mobile device (iPhone/Android phone, or tablet) or the web much faster than getting a replacement provisioned device, and with the seamless omni-channel experience offered by many providers out there, your data is safer than ever. Tamagotchis and MP3 players are no longer around for a reason. We rarely use computers to access email outside of critical work operations. We always have our phones by our side. The elderly still don’t use email addresses, so how viable and relevant is the web as the only backup mechanism for eCOA/ePRO operations? I’ll tell you how—significantly less than 1%. If we can evolve the world when everything stops by driving the BYOD strategy as a real and successful collection mechanism for millions, there’s no need to go back.

Whilst there is no formal FDA guidance for BYOD in ePRO/eCOA trials, commentary on the use of BYOD tools has been included in the recent draft of Digital Health Tools and Patient-Focused Drug Development guidances. BYOD is now widely accepted, and it is working as the primary and secondary mechanisms for data capture. Provisioned devices are now firmly in the rearview window, and in the rarest of cases, they provide a pathway for the few who are less accustomed to modern technologies. Let’s work smarter, not harder. Saving millions of dollars in unnecessary hardware, countless hours of life supporting irrelevant technology extensions, and innovating what truly matters—better experiences for everyone, everywhere.

Talk to THREAD about how we can protect your data – enabling relevant, non-invasive ‘get in, get out’ experiences for eCOA so patients can continue to focus on what matters most: life. Powered by simple-to-use engagement mechanisms to keep site staff and patients connected, always. For more information, visit THREADresearch.com

(1) Stone, A. A., et. al. (2002). Patient non-compliance with paper diaries. British Medical Journal, 324, 1193 – 1194