'A fifth of cancer trial sites enrol only one patient'

Clinical data analytics firm Phesi looked at 173 trials staged at nearly 12,000 sites – involving almost 84,000 patients in 57 countries – from the last three years.

Its findings revealed that 19% of sites examined managed to enrol just one patient, at a cost per individual that was close to 10 times greater than the best performing sites. Furthermore, well over half of all patients (54%) were dealt with by the top performing 16% of clinical sites.

Phesi founder and CEO Dr Gen Li expressed concern that the least successful sites were contributing to unnecessary cost and delay in accurate data collection.

“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,” he warned.

“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.”

Phesi’s cancer-specific data parallels previous clinical trial research published by the Tufts Center for the Study of Drug Development in 2018 in Nature. This concluded that 11% of sites in clinical development failed to enroll a single patient and more than one in three (37%) under-enrolled.

“Clinical development has a chronic issue with trial enrolment, with almost one fifth of trial sites contributing just 3% of patients,” stated Li.

“At the other end of the spectrum, a small proportion of better performing trial sites contribute almost half of patients.”

With the bill for site activation alone calculated by Phesi at $40,000, together with management costs averaging $3,000 per month, there is a wide discrepancy in cost per patient. Phesi calculates the patient cost for best-performing sites at just $14,167, compared with a massive $130,000 at a single patient site.

The solution, said Li, was to eliminate single patient sites by harnessing solutions including predictive analytics, simulated trial design and enrolment performance, and using digital patient profiles for  simulations. These could then be employed to select the highest performing recruiting countries and sites for accurate recruitment scenario modeling, he explained.

Of the 173 clinical trials in Phesi’s analysis, 81 were Phase 3 and 51 Phase 2 (51). All but four of the trials had 10 or more enrolling investigator sites. Country-wise, the lead locations were the USA, Germany, Japan and the UK, while top clinic sponsors included Hoffmann-La Roche, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Pfizer, plus Merck Sharp & Dohme Corp .