One million dollars. That’s the expected operational cost of running a clinical trial per day. This figure underscores the incredible potential for loss the clinical trial market incurred during the COVID-19 pandemic. Like any global disaster, the arrival of COVID-19 served as an accelerator for many aspects of healthcare. One particular area of rapid transformation was the adoption and practical application of virtual healthcare, an area of tech-meets-medicine that up until that moment had only been dabbled in.
The increased demand for health services in conjunction with the need to reduce face-to-face interaction was, after all, a perfect catalyst for change. Predictably, telehealth services took off exponentially during the pandemic. Per-visit costs were contained, providers remained productive, and patients retained health access. Win-win-win.
Despite its obvious appeal, the integration of telehealth into the complex process of interventional clinical trials in humans—known as decentralized clinical trials, or DCTs—proved to be a more complicated reality.
The unique needs of clinical trials
Clinical trials are often the longest, slowest, and most expensive phase of new drug development. Fundamentally, the ethical and equitable management of complex medical patients on experimental medications with unknown safety and treatment profiles is often a painstaking and hands-on process.
Novel trials require a highly targeted protocol to properly collect data and ensure patient safety. Patients must be recruited, screened, dosed, and monitored over a timeline lasting anywhere from a few months to upwards of five years. A supply chain of specially configured materials and equipment must be precisely managed.
Which is to say, every one drug investigated requires thousands of highly trained professionals—the very ones reliant upon regular interfacing as critical to the process. Even before the constraints of the pandemic emerged, many practicing physicians were drifting away from clinical research.
Can technology help?
It’s hard to overstate the accumulated impact of technology on our daily lives over the last several decades. Our increasing ability to reliably gather information, share complex ideas, and coordinate activities across a wide swath of the population has acquired the popular mythology of “disruption” in the popular press.
In this disruption we have seen many well-respected industries falter and even disappear as technology provides new capabilities, reduces cost, and regularly creates large, new companies. Such is the fickle impact of tech in these spaces. If it works, its in; if it doesn’t, it’s on to the next at breakneck speed.
Well-funded tech innovators have long had their eye on disrupting healthcare delivery through the creation of on-line patent care and medical management offerings. However, the pace of uptake for these new technologies by doctors and patients alike has been curiosity-fueled at best.
The idea that traditional healthcare—with in-person delivery provided in high-cost medical centers—could possibly be disrupted would have taken extreme circumstances. Then COVID entered the chat.
DCTs—what works
The medical crisis brought on by the pandemic accelerated the urgent adoption of telehealth technologies into clinical trial protocols. Many positive features were readily apparent, allowing for new studies to be managed—at least partly—on-line.
Research teams and patients are now more open to remote video visits. Furthermore, impressive improvements and wide-spread availability of wearable health devices now allow a great deal of remote data collection and patient monitoring to facilitate this approach. Given this continued flexibility, many previously uninterested potential research participants may take a new interest in joining a clinical trial.
The potential for positive tech-driven disruption in medical research is very real for perhaps the first time ever. But potential alone does not have the final say when it comes to shifting healthcare delivery culture, a necessary component to lasting change.
DCTs—what isn’t working
Despite recent and impressive advances, many obstacles remain and the prognosis for decentralized clinical trials remains somewhat…guarded. While there are many new tools and online applications available to researchers, most clinical studies still hinge on the integration of such capabilities.
In order to fully collect all the needed data, an extremely nuanced process must be adhered to. One technologically driven misstep can yield extremely expensive and devastating consequences—especially when it comes to participant safety and continuity of care.
The burden of preventing human error doesn’t just lie with the researchers themselves. While these new technologies are impressive, they are not yet user-friendly enough for wide adoption, particularly for older, sicker patients who often make up the bulk of clinical trial participants.
Furthermore, health inequity systems hinder access to the smart-phone and broad-band internet capabilities needed to participate for some lower-income patients. This presents an ethical catch-22 for the very same participants who often join clinical trials for the compensation and access to free medical care.
Can the convenience of DCTs produce faster, cheaper clinical trials?
These examples cite simplified obstacles collectively experienced in DCTs launched during the pandemic. Unsurprisingly, DCTs have so far incurred significantly higher costs as compared to similar low-tech clinical studies. On a humanistic note, both researchers and clinical trial patients frequently report comparatively higher dissatisfaction rates due to tech glitches and the lack of human interactions and support.
As for the well-funded tech investors betting on disruption in this new market?
Many high-flying DCT companies who went public at multi-hundred-million and billion-dollar valuations in 2020–2021 have recently seen their valuations plummet and their stocks de-listed. It’s not clear if the investment community will continue to support the needed development and tech integration efforts needed to deliver on the promise of decentralized clinical trials.
Nor is it clear, with the slow exit of the pandemic and its pressure-cooker influence, if the research community is willing to withstand the growing pains of change. For now, the sign off is a familiar one: more research is needed.
By Scott Whitt, President and General Manager at Triad Clinical Trials