Global oncology trial investigator sites increased by half in five years, finds new Phesi analysis
28 May 2024
Global cancer trial investigator sites have increased 50% in just five years but led to a rise in the number of poorly performing sites, new research has revealed.
Latest analysis by leading clinical development analytics company Phesi, released ahead of this year’s American Society of Clinical Oncology (ASCO) annual meeting, analysed 11,755 Phase I, II and III oncology clinical trial sites open for recruitment since 2019. It showed a 49% increase in recruiting oncology investigator sites.
While the data confirmed the US domination of oncology research, the fastest continental growth was demonstrated in east Asia, particularly China.
The country recorded by far the greatest increase with 374% over the past five years, more three times the growth achieved by second placed Brazil (158%) and more than four times the 87 % rise recorded by Spain. Other significant increases were posted for South Korea (83%) and Taiwan (69%).
However, Phesi president Dr Gen Li warned that, although cancer remained an area of high investment in the pharmaceutical industry, pressure was increasing on investigator sites.
“There has been rapid progress in precision medicine, but the same level of precision is not yet given to investigator site selection and country allocation. The saturation of investigator sites in certain areas increases the number of non-performing and poor performing sites, resulting in trial failures,” he stated.
He pointed out that Phesi’s previous analysis of enrolment data from oncology trials found nearly 20% had enrolled only a single patient, delaying life saving medicines reaching patients and increasing costs.
And data on non-small cell lung cancer (NSCLC) found the 471 recruiting Phase I trials recorded targeted more than 20 specific genetic markers. One fifth of the investigators working on these trials were shown specialised in different areas of oncology, with no history of strong recruitment in lung cancer studies.
Analysis found too that the top 100 lung cancer investigator sites in the US each recruited for 39 trials on average. The report warned that single investigator “cannot meaningfully recruit patients for 39 trials, demonstrating how overly burdened investigator sites will predictably have a detrimental impact on oncology clinical development”.
It added there was an obligation on sponsors to be truly data-driven in their design and operations and to select the “most relevant, high enrolling investigators” to relieve pressure on sites and increase the success rate of trials.
Using patient-centric data to inform and optimise trial protocol design will lay the groundwork to successfully deploy external control arms and digital twins, minimising the burden on patients and investigators even further commented Gen Li.
Phesi’s second edition of its Digital Patient Profile (DPP) catalogue, using its Trial Accelerator platform, contains data from 108 million patients from 195 countries.
Pic: Pranidchakan Boonrom
