Phesi Inc., a global provider of clinical development data analytics, has published an analysis of site-level enrolment data from 173 cancer clinical trials conducted in the past three years.
The data, spanning 83,916 cancer patients from 57 countries, reveals that of the 11,826 investigator sites participating in these trials, 2,298 (19%) enrolled just one patient (Fig 1).
The findings correlate with research from the Tufts Center for the Study of Drug Development (Tufts CSDD), which found that 11% of sites in clinical development fail to enroll a single patient and 37% under-enroll; Phesi’s data analysis reveals the scale of the challenge specific to cancer trials.
Recruiting sites are costly to establish and run. Activating a recruiting site costs a minimum of $40,000, with monthly investigator management costs of around $3,000. Phesi’s analysis reveals that single patient sites cost $130,000 per patient, almost 10 times that of the patient cost at a better-performing site of $14,167 (Fig 2). Not only are single patient sites fiscally inefficient, but they also raise serious questions around data quality, as data outliers are not as easily identifiable.
“Single patient sites are a significant challenge in trial enrolment – prolonging cycle times and exposing data quality issues, even leading to trial failure. In cancer specifically, the risk of measurement deviation is high due to the subjective disease measures often observed in patients,” said Gen Li, CEO and founder, Phesi.
“Simply by eliminating sites that only recruit single patients, cancer clinical trials can vastly reduce costs. With a smarter approach to protocol design that addresses recruitment issues, sponsors can improve performance across investigator sites.”
The majority of trials in Phesi’s analysis were phase 3 (81) and phase 2 (51); 169 of the 173 trials had 10 or more enrolling investigator sites, and the percentage of single patient sites across the trials analyzed ranged from 2%-76%.
The top sponsors of these trials were Hoffmann-La Roche, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Merck Sharp & Dohme Corp., and Pfizer. The most commonly used countries to locate trials are the U.S., Germany, Japan and the U.K.
“Clinical development has a chronic issue with trial enrollment, with almost one fifth of trial sites contributing just 3% of patients,” Li said.
“At the other end of the spectrum, a small proportion (16%) of better performing trial sites contribute almost half of patients. Sponsors can change the status quo and eliminate single patient sites by embracing new approaches, including predictive analytics, simulating trial design and enrolment performance, and using digital patient profiles at the core of these ‘what if…?’ scenario simulations. These can be used to select and profile the highest performing recruiting countries and sites for an indication and carry out accurate recruitment scenario modeling.”
Phesi uses the world’s largest clinical trial database to simulate clinical development and improve decision making. Phesi’s AI-driven solutions for patient profiling, trial simulation, protocol design and digital twins and trial arms successfully support life sciences companies in accelerating drug development and commercialization.
Access the full report here.