The Real Bottleneck in Clinical Trials Is not What You Think

For an industry that invests heavily in technology, data infrastructure, and process optimisation, clinical trials remain surprisingly slow, complex, and costly.

The instinctive response has been to focus on improving systems, streamlining workflows, enabling interoperability, and accelerating data flow. These are important efforts, and they are beginning to deliver results.

 

But the discussions at the Vulcan Futures Roundtable revealed a more fundamental constraint, one that sits at the very heart of clinical research.

 

The biggest bottleneck is not data. It is patients.

 

The Constraint Nobody Talks About

This may seem counterintuitive in a data-driven industry. But one participant made the point with striking clarity:

 

“Even if we solved everything, set up a study in one second, locked the database and reported it in one second, it would pale into insignificance relative to the time and money spent on patient identification, recruitment, and retention. That is actually the problem.”

 

No matter how efficient our systems become, clinical trials cannot progress without the right patients, identified at the right time, and connected to the right opportunities.

 

Today, that process is still deeply fragmented. Patients are often diagnosed within healthcare systems that have limited visibility of ongoing clinical trials. Physicians, focused on immediate care, may not be aware of relevant studies. Even when opportunities exist, the pathways to connect patients to trials are slow and indirect.

 

Darren Weston of J&J described a telling scenario: a patient diagnosed with cancer by their primary care physician, who neither treats cancer nor has easy access to information about relevant trials. That connection between the patient and a potentially life-changing research opportunity remains difficult to make. The result is that many eligible patients are never identified, while trials struggle to recruit efficiently.

 

Glimpses of a Better Future

There are already early signs of what a more connected approach could look like.

Darren also described a company now using insurance data to identify patients the moment they receive a cancer diagnosis and immediately connecting them to relevant trial opportunities. It is an imperfect solution, but it is a working one. Enabled by FHIR, it demonstrates that the data infrastructure exists to begin tackling this problem.

 

In parallel, direct EHR-to-sponsor data transfer is reducing the burden on clinical sites and beginning to create the conditions for faster, more efficient trial operations. Importantly, the momentum here has not come primarily from sponsors. As Lilliam Rosario observed, it has been driven by healthcare institutions themselves, seeking efficiency gains that reduce the cost and complexity of running trials. The economics are straightforward: if participating in clinical research becomes cheaper and less resource-intensive, more institutions will do it.

 

“The incentive is not initially on the sponsor. The incentive is actually on the institutions because there is a huge efficiency gain for them.”

 

From Isolated Success to Systemic Change

The challenge is not that these solutions do not exist. It is that they remain limited in scale.

Moving from isolated success to systemic change requires a shift in focus. Instead of asking how to make trials more efficient internally, the industry needs to ask how to connect patients and research more effectively across the entire healthcare landscape. It requires rethinking incentives making participation in clinical research easier, more attractive, and more integrated into routine care.

 

It also requires acknowledging the sheer scale of what has not yet been done. As Chris Price noted, data from limited sites flows to limited sponsors and that is nowhere near enough. The early adopters are demonstrating what is possible. The broader community needs to follow.

 

This is where Vulcan has a critical role to play. By bringing together the organisations responsible for different parts of the ecosystem -sponsors, technology vendors, implementers, healthcare institutions, Vulcan creates a platform to address the disconnect. Not just technically, but strategically.

 

Because the future of clinical trials will not be defined by how well we move data. It will be defined by how effectively we connect people.

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