Expanding clinical trial access through technology, support

Barriers to expanding trial access

There are several roadblocks to expanding access, one of them being limited participation.

"One of the biggest barriers is that community-based sites, which tend to have greater access to underrepresented patient populations, historically have only participated in clinical research in a limited manner relative, for example, to academic or specialty research sites," Shimooka explained.

This limited participation stems largely from concerns over scalability and sustainability.

For smaller companies, clinical research requires substantial upfront training, staffing and technology costs that might not justify the return on investment for only a couple of short-term studies.

"It's a risk, and there's little guarantee of future opportunity," Shimooka admitted. "Even if a practice is motivated, the burden is high, especially when already managing a full patient load."

That burden is then amplified when practices begin to juggle multiple sponsors, especially when each requires different systems. Without the infrastructure to reduce redundancies, scaling becomes nearly impossible.

According to Shimooka, this pattern extends across federally qualified health centers and regional medical groups, where short-term trials often leave communities disillusioned once sponsors leave.

"The communities rally and get patients for the trial, but then they're left wondering, 'Where did you go?'" she shared.

Interoperability

While technology can be used to expand trial access, it also has the potential to create additional barriers when not appropriately aligned with real-world care.

Take, for example, electronic health records (EHRs). 

Shimooka pointed out that the greatest opportunity lies in "figuring out how to leverage EHRs and bring the technology systems that pharma uses closer to the language of providers," as they are currently very separate.

Because many of the data points needed for research are not captured in EHRs, clinical studies often run parallel to, instead of within, routine patient care. That disconnect forces investigators to duplicate work by entering the same information into multiple systems, which wastes time and money.

For community-based organizations already stretched thin, this extra step alone can be enough to discourage participation.

If sponsor systems could be integrated directly into the tools providers are already using, the process would be far less burdensome.

Instead of toggling between separate platforms, physicians and staff could capture research data as part of everyday care. This type of technology integration would also improve data quality by reducing transcription errors and eliminating inconsistencies across systems.

Bridging this gap could be one of the most powerful levers for expanding trial access at scale, Shimooka suggested.

Patient–provider support

While eligibility opens the door to clinical research, it is really personal finances, cultural practices and day-to-day logistics that ultimately determine who gets to step through and participate.

To prevent this, trial designs need built-in adaptability, as no single model will work for every patient or study.

"Patients need flexibility. That means offering different ways to participate based on their preferences, digital literacy, cultural background and local resources," Shimooka continued. "For some, this could mean virtual visits or remote data capture; for others, face-to-face interaction may feel more comfortable or trustworthy."

Factors like travel expenses, time off work and the need for childcare put participation out of reach for many. These barriers often fall hardest on underrepresented groups, which are populations the industry needs to engage the most.

But Shimooka was quick to point out that the burden of trial participation doesn't fall on patients alone. Providers and their care teams also face their own set of challenges.

"They're already overwhelmed by administrative burdens and reporting requirements," she mentioned. "We have to design trial models that don't create more friction."

Technology integration

Shimooka pointed to some solutions that are beginning to show promise, including flexible scheduling, mobile research units that bring studies into neighborhoods and remote data capture, which limits unnecessary visits. However, these options are only effective when aligned with the characteristics of the population being studied.

An approach that works for an urban, tech-savvy patient population might not translate well to a rural community with limited internet access.

Shimooka reiterated that although technology-driven tools such as decentralized trial components, digital health platforms and artificial intelligence (AI) can broaden access and improve efficiency, their value depends entirely on where and how they are deployed. 

"Rather than starting with the technology, it's more effective to begin by asking, 'What problem are we trying to solve, and for which patient population?'"

If applied correctly, AI could help accelerate this move toward more flexible trial designs. Beyond cleaning up the growing volumes of data collected through digital tools, AI could make trials more appealing to patients by reducing reliance on placebo groups.

"There's potential in reducing placebo arms through technologies like digital twins or synthetic control arms," Shimooka added. "That could make participation more appealing for patients who want access to therapeutic options."

Synthetic control arms utilize existing datasets to replace control participants. This benefits patients by reducing their chances of being assigned to a non-treatment group and sponsors by creating quicker trials with more reliable data. 

Closing the interoperability and patient-provider support gaps would allow more sites to take part in research. With sponsor and provider systems working together and less administrative strain on care teams, trial participation could scale more successfully.

The right technology, applied to the right trial, could help make that possible.

"If we're going to ask providers to take on clinical research, we have to make it easier, not more complicated. Otherwise, even the most well-intentioned initiatives won't get traction," Shimooka warned.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.