The COVID-19 pandemic has turned clinical operations on its head, forcing the clinical research community to re-evaluate how to manage clinical trials. In an instant, physical access to patients across the globe ceased to be an option, having a significant impact on clinical data collection and patient monitoring.
In recent years, the industry has been adopting new technology to advance the digital transformation of clinical trials. The pandemic has accelerated the concept of decentralized trials with "hybrid" (in-person and remote patient visits) or fully remote subject visits. In a study we conducted late last year, 76% of respondents indicated that the COVID-19 pandemic had accelerated their adoption of decentralized clinical trial methods.
After years of slow movement, there are many reasons why decentralized trials have seen such a rapid, and necessary, adoption.
Consider that the biggest factor delaying clinical trials today – exacerbated by COVID-19 – is enrollment. The fact is, it's just difficult to find enough patients to participate in trials. In our study, more than half (51%) of respondents identified longer enrollment timelines as one of the top impacts of the pandemic. This is in large part because of the inconvenience of trial participation for the patient. For instance, some patients may live several hours from the site, so in-person visits can eat up an entire day and be very disruptive to their life.
One critical missing piece in the shift to decentralized trials has been the adoption of telehealth and video-based clinical visits. The ability to do home health, virtual visits, and telemedicine are key to making trials more convenient for patients, which lessens the enrollment barrier. Whilst the technology has existed, two key barriers have precluded its adoption: state/regulatory support and end-user (physician) acceptance. COVID-19 has broken down these barriers, almost overnight in the U.S., triggering mass relaxation of regulatory hurdles, and likewise immediate realization by the medical community that video can work, and in many cases, is better than face-to-face interactions.
New Technologies Equals More Data
A decentralized approach also enables companies to acquire significantly more quantifiable, less subjective data, compared to traditional site-centric trials. This is thanks in part to the adoption of new technologies like wearables, medical sensors, mobile apps, eConsent, smart pills, smart home diagnostics, and voice agents. In fact, our survey found that more than 64% of respondents adopted these new, patient-facing technologies as they transitioned to decentralized clinical trials. And these companies expect that wearables and remote technology will increase patient convenience, provide a more comprehensive supply of real-time data and insights, and time and resource savings for site staff.
Thanks to wearables, smartphones, and tablets, we're moving to a world where traditional site visits will be supplemented by data from intelligent devices used by patients that may send readings multiple times a day — or even continuously. In the future, that information could be augmented with external data such as environmental factors like the weather, air quality, a patient's location, or even their activity level at any given moment, to better understand how outside factors are impacting outcomes.
Managing the Deluge
The use of this kind of real-world data in clinical trials represents a huge paradigm shift. But, with all this real-time data coming in, how does a study team manage it? The burden of data management and analysis is becoming a more urgent problem. The amount of data is far more information than humans can process or manage and outsourcing or throwing more people at the problem is no longer sustainable or effective. Not only is there more data, but it is also much more complex. Indeed, 50% of respondents to our survey indicated that data quality was a top challenge in adopting decentralized clinical trial methods.
To support the move to decentralized clinical trials, and the variety and volume of patient data that is going to come with it, organizations will really need a single platform where the data can be collected, harmonized, and analyzed quickly and efficiently. In the past, sponsors and CROs may have used point solutions designed to improve specific processes in clinical trials, such as electronic data capture (EDC) and drug randomization and supplies management (RTSM). But these systems weren't built to work together, so a lot of process redundancy and data quality issues have been introduced. Add to that the complexity of data streaming in from remote devices and patient apps, you can understand the concern.
In addition, great advances have been made in AI and machine learning (ML), which can be applied to automate many data-heavy processes to lessen the pressure. AI and ML not only process data faster than humans, but they can also point to patterns and trends that humans can't see. This will ideally lead to a more accurate and detailed view of how patients are responding in trials, which can lead to not only a better patient experience but also better therapies and treatments in the long run.
AI and ML are already being incorporated into advanced, cloud-based life sciences technology platforms to support trial design, data monitoring, and safety case management. But this is only the beginning. Five years from now, a patient's clinical trial experience could be very different. Wearables combined with cloud technologies will enable continuous and instantaneous data collection and advanced analytics that is fed back to the study teams developing new treatments. Each enrolled patient could be creating millions of data points a week—or even per day! That could mean more accurate assessments as the data will reflect the patient's everyday experiences.
Today's environment has helped push the industry from looking at decentralized trials as a series of pilots to accelerating adoption because they are simply a better way to operate. There's no question organizations have adapted to decentralized trials very quickly in the face of the global pandemic, but the industry needs to embrace this change not as situational, but as a permanent evolution. It's clear with the right processes and technologies in place, the shift can be advantageous to patients, sites, and sponsors moving forward. Ultimately, decentralized trials will change clinical research forever, driving patient centricity, richer real-world data, and faster development of life-enhancing therapies and treatments.