Saturated sites and design complexity undermining phase 3 trials, warns Phesi chief
20 Jul 2025
Complex trials and saturated investigator sites risk wasting billions in money spent on clinical investigations, warned the head of data analytics firm Phesi.
Founder and CEO Dr Gen Li was speaking after the release of its latest report on the conduct of global phase 3 trials, using data from its AI-powered Trial Accelerator.
The company highlighted the issue with a focus on industry-sponsored trials researching atopic dermatitis (AD) that recruited patients in June last year. It said AD affected around 200 million people globally, with 18 active trials.
“For sponsors, being first to market in a competitive space is critical – so designing smarter trials that mitigate recruitment issues and optimize endpoints will increase chances of success,” Li explained.
“And for patients, it’s important that trials put them at the heart of the protocol design to ensure the burden patients face is minimised.”
Phase 3 investigations, which are designed to test the safety of new treatments, comparing them with standard industry therapies in use, tend to be substantially larger than preceding phases.
However, warned Li, data value could be compromised thanks to needlessly complex trial design and overdependence on the same population sources.
The most extreme example cited in the report was a site in California consisting of just 55,000 inhabitants from which the investigator was for 14 AD trials.
Overall, said Phesi, the number of recruiting AD trial sites rose 205% in just four years – leaping from 1,944 in July 2021 to 3,981 in June 2025 – an increase “beyond the global clinical development capacity for AD”.
“Phase 3 trials are high stakes for clinical development businesses. Late-phase programmes are time consuming and involve significant investments, so carry considerable financial risk.
“Sponsors are under increasing pressure to deliver cost-effective therapies faster but risk failing against their commercial objectives if they continue to neglect real-world data and AI-driven clinical data science to support the design, execution and interpretation of trials,” commented Li.
Phesi chief operating officer Jonathan Peachey added that failure to integrate clinical data sciences in late-phase studies remained “a significant missed opportunity” to make trials smarter, and to increase the probability of technical and regulatory success.
“Atopic dermatitis is just one example – the risk to phase 3 trials extends to all indications and disease areas, including rare diseases,” he added.
Pic: Ivan Samkov
