Prior to SCOPE, Phesi unveiled analysis that revealed the problem within clinical trials of insufficient levels of recruitment leading to some trials going ahead with only one patient.
The statistics showed that 2,298 of 11,826 of investigator sites in cancer trials over the past three years had only enrolled a single patient.
As a result, the costs for such trials were far higher than the average: a single-patient site had an average cost-per-patient ten times higher than a better performing site. Phesi stated that single-patient sites cost approximately $130,000 (€121,479) per patient, compared with a better performing site costing on average $14,167 (€13,238).
In addition, the research found the top 16% of investigator sites contributed 54% of patients. By contrast, a fifth of sites provided only 3% of all patients.
Outsourcing-Pharma spoke to Phesi CEO, Gen Li, to better understand why this situation is occurring and what can be done about.
When asked about why, despite the cost, single-patient trials are still occurring, Li answered: “Despite continuing efforts from the industry, most clinical trial sponsors do not adopt a data-driven approach to study design and trial execution, or use predictive analytics to accurately simulate outcomes. Sponsors are failing to access and systematically analyze real-time data at the required volume to identify and address poorly performing countries and sites. The feasibility tools used and the sources of data accessed are insufficient and are contributing to this industry-wide problem.”
He added that failing to use data was leading to sponsors and clinical development personnel to “fall back on gut feeling” and other preconceptions about recruitment trends when writing a protocol.
In terms of what the better performing sites are doing to boost their recruitment, Li outlined that they generally have access to the right number and type of patients, a well-established infrastructure for clinical trials, and a strong understanding of the disease area. In addition, he stated that operating clinical trials can be complicated by poorly performing sites diverting resources away from sites that are recruiting well.
Li concluded: “Sponsors should focus less on trying to make a large number of non-performing sites perform, and instead working closely with lead enrolling sites to maximise recruitment.”
In regard to the kind of conversations that Phesi had held with the industry at the SCOPE event, Li said, “The largest pharmaceutical companies at SCOPE have shown renewed interest in investigator site enrolment performance and our latest data analysis because it highlights the practical implications of single patient sites on operational costs and cycle times. With predictive analytics and accurate scenario modelling, we have the opportunity to improve investigator site enrolment and eliminate these challenges.”