Phesi CEO warns phase 3 trial failures loom as sponsors overlook real-world data and overcrowd investigator sites

New data reveals sponsors risk wasting billions by designing overly complex trials and repeatedly recruiting from oversaturated investigator sites

Boston, US. 9 July, 2025. Dr. Gen Li, CEO of Phesi, a global provider of patient-centric data analytics, has warned the clinical development industry that phase 3 trials in multiple indications are heading for avoidable failure. Overly complex trial design, coupled with a lack of real-world data integration, is leading to investigator site saturation and increased burden on patients and investigators. To highlight the systemic issues, Phesi has published a new report using data from its AI-powered Trial Accelerator™ platform focusing on phase 3 studies in atopic dermatitis (AD), a particularly active indication in development currently. Analyzing industry-sponsored phase 3 trials recruiting patients in June 2024, Phesi found that AD, which affects more than 200 million people globally, ranks second highest after non-small cell lung cancer, with 18 active trials.

“Phase 3 trials are high stakes for clinical development businesses. Late-phase programs 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 Dr Gen Li, Phesi CEO and Founder. “With so many active studies, there are exciting new treatments and modalities in development for AD. 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. And for patients, it’s important that trials put them at the heart of the protocol design to ensure the burden patients face is minimized.”

Phesi’s report finds that AD trials are at risk of severe enrollment difficulties: the number of recruiting AD trial sites has risen 205% in just four years – from 1,944 in July 2021 to 3,981 in June 2025. This increase is beyond the global clinical development capacity for AD. Phesi’s analysis found one such extreme example at an investigator site based in Fountain Valley – a Californian village of 55,000 inhabitants where the investigator is currently recruiting patients for 14 AD trials. Phesi also created a Digital Patient Profile for adult AD to provide a statistical view of the patient population. Further analysis of the DPP against the phase 3 trial landscape finds near-perfect correlation between EASI (Eczema Area and Severity Index) and %BSA (percentage of affected body surface area). EASI is a complex score involving multiple factors, %BSA is a simple disease measure – a clear opportunity to simplify metrics and reduce patient burden without compromising scientific rigor.

“Atopic dermatitis is just one example – the risk to phase 3 trials extends to all indications and disease areas, including rare diseases,” commented Jonathan Peachey, Phesi’s Chief Operating Officer. “Failing to integrate clinical data sciences in late-phase studies is a significant missed opportunity to make trials smarter, and to increase the probability of technical and regulatory success. This includes reducing enrollment delays caused by investigator site saturation and sluggish investigator site activation by a CRO and reducing misalignment between feasibility data and actual site activation and enrollment. The potential of AI in clinical development is huge – from precise scenario and prediction modelling, developing accurate digital twins, reduced complexity in trial design, and precision in selecting lead enrolling countries and investigator sites. The time is now for sponsors to adapt and evolve their approach to strategic and operational feasibility.”

The new report, which also contains the full Digital Patient Profile (DPP) for adult atopic dermatitis, is available here, Atopic Dermatitis: Key Learnings from Phesi’s Analysis of Phase 3 Clinical Trials.

Phesi’s AI-powered Trial Accelerator™ platform holds contextualized and global data on more than 200 million patient records from over 4,000+ indications. Phesi’s DPPs use key demographics including age, sex, comorbidities, outcome measures and concomitant medications to enable sponsors to understand the patient population in detail and design better protocols. From the DPP, Phesi derives the Patient Access Score, a unique performance measure that lets sponsors precisely select the best performing investigator sites across 195 countries and eliminate non-active, non-enrolling investigator sites.