The FDA's new real-time clinical trial monitoring initiative, which allows regulators to see live data, is designed to speed drug development. But it could also tilt the clinical playing field in favor of large pharma companies with the technical and financial resources to support it.
The agency recently unveiled two proof-of-concept trials sponsored by pharma giants AstraZeneca and Amgen and is looking to build on them with a broader pilot program slated to launch this summer.
The companies that choose to participate in the voluntary pilot will help shape the standards and expectations around real-time monitoring. If smaller biotechs don’t also throw their hats in the ring, they risk having to adapt to rules they didn't help create, potentially putting them at a disadvantage, said Aman Khera, an industry regulatory science and innovation expert who advises trial sponsors of all sizes.
The FDA’s push toward real-time monitoring of safety signals and endpoints is a major win for Big Pharma — but for smaller biotechs, academic trial sites and nonprofits, which all share similar constraints, the shift may be challenging, said Khera.
While the regulatory agency says its long-term goal is to make real-time monitoring accessible across the industry, the early lift is likely to fall more heavily on smaller organizations.
In general, large pharmas are better positioned to handle real-time clinical trials than smaller companies because they typically have a digital infrastructure capable of storing, integrating and continuously processing vast amounts of clinical data. This infrastructure is becoming more important as trials grow more complex. Late-stage trials in particular now collect an average of 5.9 million data points, which has increased by 11% every year since 2020.
But data infrastructure is just one way the FDA's push for speedy drug approvals could impact small biotechs differently. Interoperability is another major hurdle, Khera said.
“We can’t have a different hierarchy according to the size of the company or the money invested."
Aman Khera
Regulatory science and innovation consultant
Clinical trials use a patchwork of software systems, electronic health records, vendor and data platforms to capture ballooning datasets, but they don't easily "talk to each other," Khera said. Real-time monitoring requires sponsors to integrate data continuously across all technology platforms and AI-driven tools.
Large pharma companies can generally afford to build or negotiate for those sophisticated integrations since they have bigger budgets, larger IT teams and ultimately more leverage with vendors. But the story is different for smaller biotechs, especially startups or ultra-rare disease companies.
The shift could also create new operational burdens and increase workloads, especially for trial sites, Khera said.
To participate in real-time clinical trials, sponsors may need to build out their cross-functional monitoring capabilities and review processes. They also might have to support additional site training and expanded vendor oversight. This adds to the "operational lift," Khera said, which could hamstring smaller trial sponsors with fewer staff and limited resources.
Big companies usually have the ability to absorb additional demands and extend support to trial sites. Smaller companies, however, may struggle — particularly those that rely heavily on vendors or partners that aren't yet equipped for real‑time workflows, Khera said.
Regulatory engagement could become another dividing line.
"Real‑time trials will require a significant amount of early regulatory engagement with the FDA to align on which signals will be monitored, how they’ll be transmitted and what will trigger action," Khera said.
While larger pharma companies typically have dedicated regulatory affairs teams that can focus on this level of planning and coordination, smaller biotechs may only have a few regulatory staff members managing multiple responsibilities at once, Khera said.
How biotechs can prepare
Vendor leverage could become increasingly important as the FDA raises expectations around AI integration and live data systems.
"Big Pharma can push their technology partners to upgrade systems, integrate AI tools and meet FDA expectations," Khera said. "Smaller biotechs don’t have that negotiating power and often end up with off‑the‑shelf solutions that may not meet real‑time requirements."
Because streaming data continuously introduces new risks around privacy and system integrity, cybersecurity and compliance are also areas that smaller biotechs will need to build out to help identify vulnerabilities and avoid breaches that could impact operations, Khera said.
Still, the FDA's initiative represents the right long-term direction for the industry even though "the bar to participate is high," Khera pointed out.
Although Big Pharma is better positioned to meet that bar, smaller biotechs can still get there with strong partnerships, early regulatory engagement and a clear data strategy from day one, Khera said.
At the same time, Khera cautioned against allowing real-time trials to deepen inequities across the drug development ecosystem.
"We can't have a different hierarchy according to the size of the company or the money invested. There shouldn't be a difference in inclusion — that foundational pathway needs to be accessible to all," Khera said.
