Jiang Li, Ph.D., is the Founder and CEO of Vivalink, Inc.
Hybrid and decentralized clinical trials (DCTs) have been gaining momentum in recent years. Following the pandemic, sponsors and regulators increasingly adopted remote-friendly designs, regulatory agencies encouraged their adoption and digital health companies developed tools to facilitate these trials.
In 2023, the FDA issued draft guidance on DCTs that promoted the use of decentralized elements, such as remote data collection, telehealth visits and wearable sensors, to enhance trial flexibility, efficiency and inclusivity. This guidance was finalized in September 2024, solidifying the FDA’s support for incorporating decentralized elements in clinical trials.
Policy shifts threaten progress.
That momentum is now under pressure. The National Institutes of Health (NIH) funds the bulk of medical research in the U.S. But a new federal policy would cap overhead reimbursement at 15%, reducing indirect cost support for many research centers and potentially reshaping how academic science is funded.
Plus, the Department of Health and Human Services has begun cutting nearly 10,000 employees and plans to eliminate a total of 20,000 positions. The layoffs, part of a sweeping restructuring effort, have already impacted core health agencies like the NIH and FDA. As a result, trials have been paused, grants delayed and many research institutions, including major universities and academic medical centers, have reduced staff or scaled back operations.
These shifts have posed major challenges for the implementation of DCTs in academic and early-stage research, where adoption was just beginning to gain traction. With fewer staff and less funding, institutions face greater barriers to adopting and managing the technologies essential to decentralized trial models.
Yet regulatory support for DCTs, and the need for efficient and accessible trials, haven’t gone away. Technology alone can’t offset these setbacks, but it can help support ongoing research by reducing operational burden, enabling remote participation and helping sponsors manage studies with fewer resources.
Prioritize interoperability.
The increased application of DCTs has introduced a growing array of tools into how research is conducted, including wearables, remote monitoring devices, telehealth platforms, mobile apps and dashboards. But as academic institutions and research centers face staffing cuts and constrained budgets, managing a patchwork of disconnected systems is increasingly unsustainable.
This environment heightens the need to prioritize interoperability. Even before these changes, sponsors were leaning toward solutions that integrate easily into their existing workflows. Now, they’re looking for platforms that reduce the operational burden on already stretched teams.
Interoperability should be a core design consideration. Solutions that connect with EHRs, lab systems, participant-reported outcomes and sponsor dashboards can reduce friction, cut down on manual processes and allow research teams to focus on science instead of system management.
Equally important are ready-to-use mobile apps and connected devices that require minimal setup or IT support. Planning for integration early, both across systems and devices, can help trials run more efficiently as organizations adapt to doing more with less.
Deliver measurable impact.
With tighter budgets and increased scrutiny, sponsors need to justify every dollar. That means technology must deliver clear and measurable results, whether by accelerating recruitment, improving retention, reducing site visits or producing more complete datasets.
Flexibility is just as important. As trials evolve, sponsors need platforms that can adapt, such as being able to adjust mid-study, support multiple arms or accommodate late-stage protocol changes. Tools that can be configured on the fly or deployed across different trial designs help teams stay responsive when timelines shift or priorities change.
Real-time monitoring and continuous data collection are shifting how sponsors track progress during a trial. These technologies often surface early insights and preliminary findings faster than traditional timelines would. As a result, teams now have an opportunity to adjust mid-study, including changes to the study design, resource allocation or cohort size.
A recent study highlighted this need for adaptability, pointing to modular digital platforms as a way for sponsors to retain control when trial activities shift. But it also made clear that technology alone isn’t enough.
As these platforms evolve, clinical and technical teams will need to work together to build solutions that meet the needs of everyone involved, from investigators and sponsors to participants. Technology providers that offer both measurable impact and flexibility, without locking sponsors into rigid ecosystems, are better positioned to support research teams under pressure.
Support what remains.
Recent funding cuts are disrupting the infrastructure supporting early-stage and academic research, from lab space and shared equipment to staff and resources. While technology can’t reverse these cuts, it can support the trials that continue and help sponsors maintain critical metrics like participant adherence.
Studies have shown that technology solutions like remote monitoring and digital platforms can increase patient adherence. For example, a recent study using electronic diaries resulted in compliance rates of up to 94%, compared to just 11% with paper diaries. Another study found that remote patient monitoring has been proven to improve adherence to medications and lifestyle changes.
Platforms that can track adherence in real time, send automated reminders and flag protocol deviations give research teams the visibility they need to act quickly. These systems can alert teams when a participant’s device isn’t sending data as expected, track whether devices are being used correctly and help staff identify participants who may need follow-up. With fewer team members and more limited oversight, access to this information is important.
As research institutions shift from growth to preservation, technology is playing a more functional role. Technology can’t replace the research that’s been paused or the teams that have been downsized, but it can help keep ongoing trials on track. That includes maintaining data quality, flagging issues early and helping teams follow up when participants miss visits or fall behind.
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