Phesi Analyzes 167M Patient Records, Finds Colorectal Cancer Has Largest Oncology RWD Volume

Phesi has released a new analysis based on 167 million patient records processed via its Trial Accelerator platform, highlighting substantial disparities in real-world data (RWD) availability and trial efficiency in oncology. Colorectal cancer emerged as the indication with the most patient data—nearly 6 million records across over 18,000 cohorts—followed by breast (4.87M), lung (3.9M), liver (2.38M), and prostate cancer (2.28M).

The data also cover the top five causes of cancer death identified by WHO, totaling over 18 million patient records from more than 120,000 investigators. However, Phesi points to persistent inefficiencies in oncology trial operations. For example, only 51% of NSCLC trials are biomarker-specific, and 20% of trial investigators lacked a background in lung cancer, despite the trials targeting over 20 biomarkers. According to a different analysis, nearly one-fifth of trial sites contributed just 3% of patients, while 16% of top-performing sites enrolled almost half.

Table 1. The five cancers with the most available patient data. Source: Phesi Trial Accelerator, May 2025.

Phesi CEO Dr. Gen Li argues that current oncology clinical development is misaligned with advances in biomarker science and patient stratification, and advocates for data-driven approaches using digital twins and predictive scenario modeling. The company contrasts the success of biomarker-driven breast cancer studies with the limited progress in cancers like pancreatic, where established biomarkers are scarce.

See also: AI Meets Clinical Trials: Recent Policy Shifts & Companies to Watch

Phesi has also launched new Digital Patient Profiles (DPPs) at ASCO 2025, including disease-specific data summaries for breast cancer with PIK3CA mutations and diffuse large B-cell lymphoma. Each DPP includes data on demographics, comorbidities, outcomes, and concomitant medications to support precision trial planning.

Phesi reports having supported Merck in the development of Keytruda for non-small cell lung cancer, leveraging its Trial Accelerator platform to inform trial design and site selection. According to the company, its tools—including Digital Patient Profiles and digital twin simulations—were used to optimize protocol development and site performance, aiming to reduce cycle times and increase trial efficiency. Keytruda is one of several drugs Phesi lists among its partner projects, which also include compounds developed by Pfizer, Biogen, Sanofi, and Shionogi.

Topics: Clinical Trials