Phesi analyzed 11,755 phase 1, 2 and 3 oncology clinical trial sites open for recruitment since 2019 and found a 49% increase in recruiting oncology investigator sites.
The analysis revealed that the US still dominates oncology research, but China now plays a significant role, with recruiting oncology investigator sites increasing by 374% over the past five years.
The UK and Canada experienced the smallest growth in investigator sites, both at 20%.
Of the top five highest growth countries after the US, three are in Asia – China at 374%, Korea at 83% and Taiwan at 69%, with the other two being Brazil at 158% and Spain at 87%.
“Cancer remains an area of high investment in the pharmaceutical industry. While the news is reassuring for patients, it increases pressure on investigator sites. Many sponsors are exploring the potential of countries outside of the US to conduct trials where competition for patients and investigators is so high,” said Dr Gen Li, president at Phesi.
“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. Our previous analysis of enrolment data from oncology trials found nearly one in five enrolled just a single patient, delaying lifesaving medicines reaching patients and increasing costs.”
Further data from Phesi on non-small cell lung cancer (NSCLC) clinical trials reveals the need to precisely select investigator sites and identify the most experienced investigators.
The research reveals that the 471 recruiting phase 1 NSCLC trials targeted more than 20 specific genetic markers.
In addition, 20% of the investigators working on these 471 NSCLC trials were shown to specialize in different areas of oncology, having no history of strong recruitment in lung cancer studies.
The data also found that the top 100 lung cancer investigator sites in the US each recruit for 39 trials on average. A 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.
“Sponsors must be truly data-driven in their design and operations and select the most relevant, high enrolling investigators to relieve pressure on oncology investigator sites and increase the success rate of oncology trials,” Dr Gen Li added.
“To achieve this, sponsors must use real-world data, such as data from previous and ongoing clinical trials and Digital Patient Profiles, to gain a deep understanding of the target patient population. With a comprehensive patient view from the outset, sponsors can optimise trial design, reduce patient burden, and select investigator sites and countries with far higher precision.
“Using patient-centric data to inform and optimize trial protocol design will lay the groundwork to successfully deploy external control arms and digital twins, minimizing the burden on patients and investigators even further.
