A growing, unaddressed strain on clinical research.
Clinical trials don’t run without people. That sounds obvious but it’s a reality the industry is increasingly being forced to confront.
Principal Investigators (PIs) are exiting research at concerning rates. Study staff are stretched thin. And as trial complexity grows, the workforce tasked with delivering these studies is quietly reaching its limits.
The challenge? It’s not just a shortage, it’s a sustainability issue. And unless we rethink how we support PIs and site teams, we risk stalling the very engine that drives medical progress.
The “one-and-done” problem is real—and rising
A recent industry webinar - The One-and-Done PI & Measuring the Current Site Landscape - put data behind what many already suspect: PI turnover is more than anecdotal. It’s systemic.
Key findings from the discussion:
In a survey of 201 PIs involved in FDA-regulated trials, more than half had only conducted a single study.
44% of those “one-and-done” investigators wanted to continue but couldn’t justify the ongoing commitment under current conditions.
Time constraints, workload, and financial challenges topped the list of exit factors.
Behind these numbers is a pattern: even engaged, motivated investigators are stepping away. Not for lack of interest but for lack of support.
It’s not just PIs. Research staff are under pressure, too.
The shortage doesn’t stop at the PI level. Clinical Research Coordinators (CRCs), who carry much of the operational burden, are also in short supply.
41% of sites report PI shortages across academic and independent settings.
Over 60% report ongoing CRC shortages, disrupting trial execution and continuity.
Most sites don’t see this improving in the near future.
Taken together, the message is clear: we’re losing experience faster than we’re building capacity.
The hidden burden: administration and complexity
Behind the workforce shortage lies another, quieter challenge. One that often pushes investigators out of research even before burnout sets in: administrative overload.
Clinical trials are more complex than ever. Protocols are longer. Reporting requirements are stricter. Compliance is non-negotiable. But the systems to support these demands haven’t kept pace.
Among the most commonly cited friction points:
Protocol complexity: Study documentation is often difficult to interpret and apply in real time.
Regulatory strain: GCP, IRBs, and safety reporting continue to absorb significant PI time.
Budget pressures: Sites frequently manage delayed payments, underfunded studies, and participant recruitment costs out of pocket.
Training demands: Continuous onboarding for new platforms, systems, and requirements drains bandwidth across already thin teams.
It’s not one thing. It’s the accumulation. And it adds up to a work environment that feels increasingly unsustainable.
The opportunity: reduce friction, rebuild engagement
This is where meaningful progress can begin. While growing the clinical research workforce will take time, operational efficiencies can be implemented immediately.
Process optimization, powered by technology, is one of the clearest paths forward.
Key areas with near-term impact:
Automated documentation workflows: AI-powered tools can extract key data from protocols, reducing review time and cognitive load.
Regulatory compliance support: Intelligent systems can flag requirements, pre-fill documentation, and reduce manual errors.
Multilingual engagement: Translation tools can streamline collaboration and communication for clinical teams, improve recruitment and retention, and enhance both participant and clinicians experience.
Data interoperability: Integrating sponsor, CRO, and site systems reduces redundancy and allows research staff to focus on execution, not data entry.
These aren’t future-state solutions. They exist today and can immediately free up capacity across clinical sites.
Reframing the conversation: it’s about retention, not just recruitment
Workforce development is often framed around attracting new talent into research. But what if the more urgent opportunity lies in keeping the talent already here?
Many PIs don’t need to be convinced to contribute to research. They simply need an environment where their time is respected, their expertise is supported, and the administrative noise is reduced.
We have the tools. What’s needed is alignment: between sponsors, CROs, technology providers, and site leaders.
A final thought.
Clinical trials are becoming more patient-centric - as they should. But if we want to truly prioritize patients, we also need to prioritize the people supporting them.
At Clinials, our mission is straightforward: help investigators spend more time with participants and less time on paperwork. The human side of research doesn’t thrive in complexity. It thrives in clarity.
Let’s focus on what matters and build a clinical research ecosystem where investigators stay not just for one trial, but for the long run.
