The Internet of Things (IoT) is connecting the world in nearly every imaginable way. Innovative technology continues to shape and reshape the future of everything from automobiles and the consumer experience to travel and social interaction, but these changes have not swept evenly across all industries. In healthcare, though devices such as Holter monitors and continuous blood glucose meters have been available and in use for decades, and the term “e-health” (electronic health) arguably first emerged in the early 2000s, the digital transition has been slower.1 In recent years, consumer, patient and health care provider use of technology such as electronic medical records (EMRs), telemedicine visits and patient portals grew, but the use of digital technology in clinical trials remained fairly minimal. In 2018, an encouraging 1,177 studies listed the use of connected technology, but only 13% were Phase 1-4, with the remainder not linked to any particular FDA-defined phase.2
However, 2020 dramatically increased the rate of this digital transition. Overnight, digital technology became a necessity rather than an option as the entire healthcare industry looked for ways to maintain patient care in the face of a global pandemic. More specifically, sponsors and contract research organizations (CROs) alike sought business continuity without jeopardizing clinical trial integrity and safety/efficacy, and technology helped make that possible. This sudden, rushed timeline brought several challenges from basic access and connectivity issues to security concerns, which complicated adoption, but the solutions put in place also showed the industry what is possible.
Connected technology helped sponsors increase patient convenience, streamline data gathering and identify cost savings (quickly highlighting the potential benefits of embracing a digital transition), but today the industry finds itself at a crossroads: slowly transition back to business as usual as the pandemic wanes or continue pursuing a digital future for clinical trials. Despite familiarity with more analogue methods, continued support for the transition is essential to the future of efficient, successful trials, and the commitment to drive new initiatives and technologies must remain strong for this transition to continue gaining momentum. The future of the industry depends as much on the technology made available today as it does on the industry’s willingness to embrace these new digital options. Taking advantage of today’s technology in upcoming clinical trials can position sponsors one step ahead in tomorrow’s digital world.
In addition to eHealth (or e-Health), several terms now intermingle under the eHealth label to cover today’s digital landscape. Both telehealth (a broad term for clinical and nonclinical remote healthcare related services), and telemedicine (remote clinical healthcare) capture the field of remote care, while mHealth (mobile health) specifically addresses healthcare reliant on mobile technology.3 As the newest subsegment, mHealth covers everything from devices like smartphones, tablets, and wearables to the software and applications these devices rely on.4
When looking more generally at the digital landscape, it is also important to distinguish between digitization and digitalization, as both apply to the future of clinical trials. Gartner’s Information Technology Glossary offers the most straightforward definitions: Digitization is simply transitioning analog information or processes to digital format, “without any different-in-kind changes to the process itself,” while digitalization is the application of digital technologies that enable a digital transformation.5 For example, transferring existing printed quality of life (QOL) forms to a digital format would be digitization, but eliminating paper forms all together and transitioning to an electronic QOL system would be digitalization.
During the early years of the U.S. Food and Drug Administration’s (FDA’s) oversight of medical devices, most technology was analog. However, as technology has advanced, the FDA has strived to keep pace, and in 2005, it began issuing guidances to help support a digital transformation.6 These guidances, paired with the Center for Devices and Radiological Health’s (CDRH’s) Digital Health Innovation Action Plan and the Software Precertification (Pre-Cert) Pilot Program, are currently helping establish a digital application and product oversight process that considers a developer’s capabilities and the analytical, clinical and real-world performance of the product to help both the agency and the industry safely keep pace with e-health.7,8
Just as digital health products continue playing a significant role in the global response to the COVID-19 pandemic, the pandemic itself has significantly influenced — and accelerated — the use of digital technology. In addition to devices and software as a medical device (SaMD) being used to monitor public health, providers, patients, clinical trial sponsors and researchers have turned to remote patient monitoring (RPM) and telemedicine visits to maintain safety and integrity.7 The FDA supported these efforts with temporary guidances and policies to thoroughly evaluate new technologies over the coming months/years, and these policies are helping shape future use.9
Embracing a digital future, however, does not require reliance on the latest technology, and although the most forward-thinking companies will certainly remain one step ahead by staying up to date on technology developments, the future of digital technology in clinical trials consists of myriad incremental but important steps, many of which can already be taken.
In clinical trials, the use of digital technology can take multiple forms. The trial may be focused on the digital product itself — either validation of the product, testing its clinical use or using the product as the intervention — or simply on using the technology to collect data related to an intervention.2 Similarly, technology can be used to support decentralized trials, more expansive recruitment and real-time data sharing.
The former is easier to identify, as the use of digital technology is the focus of the trials. For example, Akili Interactive Labs, Inc. continues to achieve positive results for EndeavorRx, an immersive video game for both iOS and Android devices designed to aid in the treatment of ADHD.10 On the same side of the spectrum, AppliedVR will soon be conducting additional clinical trials for its virtual reality (VR) based digital therapeutics for the treatment of chronic pain.11
However, the devices that are front and center in both examples are not the only technology used in these trials. Trials themselves rely heavily on coordination by experienced researchers and the use of connected technology that is applied more broadly to all clinical trials. By embracing some of these same approaches, you can take advantage of today’s technology in pursuit of greater efficiency, reduced time to regulatory approval, and thus reduced time to market (all while improving the patient experience).
Decentralized clinical trials (DCTs) are already allowing trials to be conducted and/or monitored remotely with both connected devices and satellite facilities. Trial sites can become more localized, rather than built around a specific hospital or research center, easing the trial burden for participants, and improving recruiting. Patient recruitment is often a difficult process potentially leading to missed quotas, delays, and increased costs that can result in up to $8 million dollars per day in lost revenue.12 Decentralization expands the potential pool of patients, increasing the likelihood of recruitment, while also encouraging retention by minimizing travel burden to a designated trial site.
Ease and convenience are significant factors weighing on participation. Electronic patient reporting outcomes (ePRO) ease the process of reporting potential adverse events (AEs) for trial participants while increasing data access for researchers. Patients can report events as they happen, reducing the likelihood of a missed report. Electronic quality of life (QOL) forms enables patients to offer feedback regardless of location, encouraging convenient self-reporting that helps the study fit naturally into the participant’s daily life. Moreover, virtual communication with videoconferencing platforms eases researcher-subject interaction, fostering necessary study engagement and follow-up no matter location.
Proper logistic coordination becomes necessary for a DCT’s success. Shipping trial materials, including the investigation product, directly to patients alleviates the need for distribution from trial sites, supporting more efficient trial processes while demonstrating a commitment to patient convenience. This process relies on robust tracking of all materials in both directions, simplified patient setup and easy connection to all digital systems for use of the device(s) and reporting, requiring an intuitive user interface (UI).
Although patients remain the focus of these changes, each of these technology-supported initiatives results in overall time and cost savings. As technology improves, the reach and options for recruitment, engagement and logistics will also improve, as we are only at the beginning of a much larger transformation.
Advancements in wearable technology — health trackers, smartwatches, virtual reality (VR) and augmented reality (AR) — are supporting enhanced, immediate data gathering with greater accuracy. Remote diagnostics are demonstrating the potential for eliminating some lab and office visits, easing the clinical trial burden for patients with reduced mobility while providing faster results. Along with hardware, apps, SaMD, artificial intelligence (AI) and machine learning (ML) are proving useful with data analysis and organization. Even the cloud, already widely familiar to and in use by consumers and businesses alike, offers the potential for larger-scale decentralization and even greater flexibility.
Naturally, none of these opportunities come without their challenges. The data alone can quickly overwhelm without established means of analysis and storage, and patient/consumer privacy remain top priorities when gathering and managing data, because compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is essential for properly designed devices and software. More generally, the technology supporting these digital solutions and initiatives is still evolving to better serve the industry as safely as possible, and researchers with both DCT and technology experience can help simplify the process to keep your trials moving forward.
The impact of digitalization is already undeniable, and the potential for it to continue revolutionizing the clinical trial landscape is clear. Though the COVID-19 pandemic may have rushed the industry into an unfamiliar place, the industry is empowered to establish familiarity and embrace this change. With the regulatory groundwork already taking shape and innovations clearly demonstrating their worth, the only direction to go from here is forward.
1. SAGE Journals: Your gateway to world-class research journals. (2000). SAGE Journals.
2. Marra, C. (2020, April 3). Quantifying the use of connected digital products in clinical research. Npj Digital Medicine. www.nature.com/articles/s41746-020-0259-x
3. Berens, J. (2021, August 23). What is the difference between mHealth, eHealth, telehealth, and telemedicine? SBMA Benefits. www.sbmabenefits.com/2021/03/28/what-is-the-difference-between-mhealth-ehealth-telehealth-and-telemedicine
World Health Organization. (2011). mHealth: New horizons for health through mobile technologies: second global survey on eHealth. WHO. www.who.int/goe/publications/goe_mhealth_web.pdf
4. Information Technology (IT) Glossary - Essential Information Technology (IT) Terms & Definitions. (n.d.). Gartner. Retrieved October 11, 2021, from www.gartner.com/en/information-technology/glossary
5. Center for Devices and Radiological Health. (2020, October 6). Guidances with Digital Health Content. U.S. Food and Drug Administration. www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
6. Kadakia, K. (2020, December 17). Advancing digital health: FDA innovation during COVID-19. Npj Digital Medicine. www.nature.com/articles/s41746-020-00371-7
7. Center for Devices and Radiological Health. (2020c, September 14). Precertification (Pre-Cert) Pilot Program: Frequently Asked Questions. U.S. Food and Drug Administration. www.fda.gov/medical-devices/digital-health-software-precertification-pre-cert-program/precertification-pre-cert-pilot-program-frequently-asked-questions
8. Center for Devices and Radiological Health. (2020a, March 26). Digital Health Policies and Public Health Solutions for COVID-19. U.S. Food and Drug Administration. www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/digital-health-policies-and-public-health-solutions-covid-19
9. Kollins, S. H. (2021, March 26). Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. Npj Digital Medicine. www.nature.com/articles/s41746-021-00429-0
10. Landi, H. (2021, August 30). AppliedVR taps Curebase to run at-home clinical trials testing VR for pain treatment. FierceHealthcare. www.fiercehealthcare.com/tech/appledvr-taps-curebase-to-run-at-home-clinical-trials-testing-vr-for-pain-treatment
11. Jones, R. (2021, June 10). How Decentralized Clinical Trials Can Play A Role In Increasing Patient Recruitment And Diversity. Forbes. www.forbes.com/sites/forbestechcouncil/2021/06/10/how-decentralized-clinical-trials-can-play-a-role-in-increasing-patient-recruitment-and-diversity