As with so many aspects of our daily lives, the impact of the COVID-19 pandemic on clinical trials was both widespread and monumental. Thousands of trials—an estimated 80% of non-COVID-19 trials—came to a halt or were interrupted by the pandemic, which challenged the ability to conduct trials safely and effectively and was complicated by the reality that trials often deal with the populations most at risk from COVID-19 exposure1.
In response, clinical researchers turned to a range of solutions to address the effects of the pandemic on trials. And while, in most cases, it’s premature to definitively determine which solutions will outlast the pandemic, probably the most widely used and enduring will be the decentralized model for conducting clinical trials, including the digital health technologies essential to its implementation.
The decentralized trial model and its adoption prior to COVID-19
The quality- and efficiency-focused Clinical Trials Transformation Initiative (CTTI), has said that decentralized trials (DCTs) can follow a range of approaches, from fully decentralized trials to partially decentralized or hybrid trials, in which some aspects of a trial are conducted remotely while others are performed in person. CTTI notes that DCTs are trials consisting of any combination of certain core features, including no physical trial sites used in the trial, all visits performed via telemedicine or mobile/local HCPs, and/or data captured remotely through use of mobile technologies2.
While DCTs offer several advantages over traditional in-person randomized, controlled trials (RCTs) and momentum for a shift towards DCTs have been growing gradually for years, the primary driver for moving toward the model prior to the pandemic has been its patient-centered focus. The DCT model is especially valuable for patient enrollment efforts, making clinical trials available to patients at non-investigative sites and even enabling participation from home. This broadens the number and diversity of eligible participants, as trials and their benefits are no longer limited to those living near the key urban centers where RCTs are traditionally based but are also open now to those living remotely or in rural areas.
Factors facilitating the broadscale adoption of DCTs during the pandemic
While the sudden need for the safety provided by DCTs drove demand, a number of developing factors in recent years helped pave the way to facilitate their implementation when the pandemic hit.
Prior to the pandemic, there was evidence that the thinking of physicians was evolving toward the utility of patient-collected data, which accounts for a significant portion of what’s gathered in DCTs. Despite the early-stage skepticism of health professionals, Stanford Medicine’s 2020 Health Trends Report (released in Jan. 2020) revealed 80% of doctors believe self-reported data from patients’ health apps is clinically valuable, while 83% said there is clinical value in data received from wearable devices. Much of this openness can be attributed to physicians’ experience with the technology, confirming research, reimbursement coverage decisions for telehealth, and the newly-developed ability of data management systems to flow patient-reported data directly into the EHR so a patient’s data can all be viewed from a single portal.4
The rapid uptake of DCTs during the pandemic was also mirrored by the massive increase in telehealth visits. Telehealth claim lines increased 4,347% nationally from March 2019 to March 2020, according to data from FAIR Health’s Monthly Telehealth Regional Tracker5.
The U.S. regulatory environment also began to accommodate the DCT approach at the outset of COVID-19. In March of 2020, the FDA issued guidance recognizing the barriers to conducting in-person RCTs safely during the pandemic. It also encouraged researchers to consider alternatives for patient assessments and data collection, including remote data collection and remote patient monitoring via appropriate technologies paired with phone or video visits6.
Advances in the capabilities of clinical research platforms have also facilitated the transition of many in-person RCTs that have been converted to or supplemented by DCTs. Modern clinical research platforms are compatible with and can receive data from a broad range of connected patient devices, also providing the range of capabilities required to conduct trials in a completely virtual manner, if the need emerged. These include protocol design, site selection and patient recruitment, data collection, remote patient monitoring and study management, data export, product support across all phases of clinical research, and documentation capabilities to support HIPAA and regulatory compliance. Some platforms even contain rich sets of patient data to accommodate trials for specific disease states.
Value of the decentralized trial model beyond the safety needs of the pandemic
For example, researchers foresee the growing flexibility of clinical trials such that they’ll be able to limit in-person patient visits to only those that are essential. Some trial sponsors and regulatory bodies are even agreeing to allow tests to be conducted with study subjects not only in their local areas but also less frequently. Researchers are hoping these conveniences will lead to a much larger pool of patients participating in trials, which speaks again to the topic of enrollment, one of the greatest challenges to the timing and efficiency of trials and the foundational challenge DCTs were initially intended to address7.
Because recruiting diverse cohorts of trial participants has been an ongoing challenge for investigators, trial recruiters are also pushing for researchers to invest in and adopt the DCT model in order to increase participant diversity. One group of Harvard-MIT researchers maintains this could make trials and their benefits accessible to more women, rural participants, and racial groups traditionally underrepresented in clinical research8.
Beyond the pandemic, the use of DCTs also opens opportunities for a range of efficiencies that are also more convenient for study participants. DCTs can use telehealth, for example, to take patient histories, obtain patient consent, and even convene remote cognitive and neurological exams, in which a healthcare professional can observe eye movements, reflexes, or how a subject walks9.
And, of course, investment in technologies that facilitate DCTs would increase the preparedness and resilience of clinical research programs when facing future large-scale emergencies10.
That level of preparedness was, in fact, one of the key findings of a research team at the Tufts Center for the Study of Drug Development, which conducted a qualitative study in 2020 looking at the impact of the pandemic on clinical trial execution11. After conducting 25 Zoom interviews with U.S.-based executives in the clinical operations departments of various pharmaceutical and biotechnology companies, the Tufts team found that, often, those R&D organizations that self-reported success in adapting their clinical trials to COVID-19 also demonstrated at least one of four key success factors.
In addition to the success factors of organizational agility, the development of COVID-19 task forces, and having strong R&D capabilities in Asia-Pacific regions, successful R&D organizations also reported having invested in remote technologies prior to the pandemic. As a result, these companies reported transitioning more easily to trials that featured the virtual components fundamental to decentralized trials. One interviewee explained that, with the trend of shifting to a more remote model, “we were already in the process of things becoming more virtual anyway. This has definitely accelerated the process because we’ve had to adapt.” Already, the interviewee noted, they were “thinking more about how we collect data, (and) verify data from a remote perspective.”
About Zach Henderson
Zach Henderson is Chief Commercial Officer of Glooko, where he leads the company’s global growth and is responsible for all commercial efforts, including the company’s work with its key strategic partners and revenue generation initiatives. He came to Glooko from LexisNexis Health Care and Elsevier, where he served as VP of Strategy, Alliances, and Data Sourcing and was responsible for the creation and development of a strategic alliance program of go-to-market and enablement partners, the negotiation of strategic partnership deals, and the integration of new business acquisitions. Henderson earned an MBA from Villanova University.
Glooko is transforming digital health by connecting people with diabetes and their health care professionals, enabling telehealth, clinical research, and improved collaboration. The company’s software platforms, Glooko and diasend®, empower remote patient monitoring and care by collecting and unlocking the power of data. Over 3 million users have benefited from diabetes data insights using Glooko’s solutions, which are trusted by world leaders in diabetes care, and used in 27 countries across 20 languages. Learn more at glooko.com.
References
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8. Plana D., Arfe A., Sinha M.S. (2020). Re-envisioning clinical trials during the COVID-19 pandemic. Health Affairs, 8 July 2020. https://www.healthaffairs.org/do/10.1377/hblog20200702.963588/full/
9. Armitage H. (2020, Dec. 7). Running clinical trials in a pandemic. [Stanford Medicine blog post]. Retrieved from https://scopeblog.stanford.edu/2020/12/07/running-clinical-trials-in-a-pandemic/
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