The Future of Clinical Research: Digitally Transforming What’s Possible
Over the last decade, patient engagement and patient centricity have gained significant momentum in clinical research. But in today’s climate, with urgency created by the pandemic, patients have truly taken center stage as trials shift to reach and accommodate patient populations who are suddenly left physically distant from investigator sites. In tandem, virtual and digital trial methods have emerged as a solution to enable trial continuity and engage patients.
Although digital trials aren’t new to clinical research, they haven’t been as fully utilized as they could have been up until now. In part, they were assumed to be difficult to operationalize. The technology and devices were seen as complex, and patient adherence was uncertain. Additionally, the question of data privacy arose, along with the need to navigate intricate regulatory hurdles.
But now that the pandemic has rapidly ushered digital trials into the foreground, digitally-enabled study models will increasingly become the norm, even after travel restrictions ease. A recent report published by Continuum Clinical found that 60 percent of currently enrolled patients surveyed said they would value alternatives to in-person visits, including 60 percent who would prefer to record their own data via an app or device.
Regulations have pivoted and adapted to accommodate digital health, from the early steps of the 21st Century Cures Act to the FDA’s emergency guidance issued at the onset of the COVID-19 restrictions earlier this year. The EMA followed suit as well. Regulatory considerations may continue to adapt to allow for measures such as reliable shipment of clinical trial experimental treatments directly to patients and the technology to ensure and confirm receipt of those treatments.
For researchers, benefits include higher study retention rates, minimization of physical and geographical barriers, direct data capture, faster enrollment, and improved data quality and quantity. Decentralized trials may reduce investigator fees as well as site monitoring and management trial costs while reducing recruitment time and increasing patient adherence — all contributors to reductions in trial complexity and trial timelines.
But at the heart of digital trials is patient centricity. The benefits to patients are substantial: access to research regardless of location, easier enrollment and participation, more reliable engagement, minimal burden, seamless communication, and increased convenience as they participate from the comfort of their homes.
As an industry, we’ve seen the landscape of clinical trials permanently change. Patient centricity is the key to building a digital or decentralized trial. Looking forward, patients will — and should — continue to be at the center of clinical research as we develop innovative ways to collaborate with them and reduce burden moving into the future.
Digitally enabled study models will increasingly become the norm, even after the travel restrictions ease. The pandemic may have been the catalyst for the industry to advance, but PPD will use that momentum to continue to digitally transform what’s possible for patients and sponsors.