New analysis of 65,061 globally recruiting clinical trials has found that 6.7 percent of active trials are impacted by the disruption in the Middle East.
The data have been shared by Phesi, a global provider of patient-centric data analytics. Over 350,000 sites across 186 counties were included in the analysis, which revealed that Phase 3 trials were most affected, with 2,732 sites impacted (Figure 1).
Gen Li, CEO and founder of Phesi, said, "The impact on Phase 3 trials is particularly significant, as these later-stage studies involve larger, committed patient populations and represent years of investment. Patient safety and the safety of investigators and clinical staff must remain the primary consideration, alongside the need to keep existing trials going."
The Mediterranean countries of Turkey, Israel, and Egypt were most affected by the conflict, followed the Gulf States, Iran, and Iraq (Figure 2).
All ten of the top global pharmaceutical companies have investigator sites in the affected countries, with some having over 400 sites, which suggests threats to trial continuity.
Oncology trials account for a large proportion of those affected, with breast and non-small cell lung cancer being the most impacted diseases (Figure 3).
“Such periods of disruption reinforce the need for a precise, data-driven approach to development,” said Li. “Sponsors need to quickly understand their exposure, identify alternatives and adapt trial strategies in real time, while maintaining high standards of patient safety and data integrity. There is also an opportunity to explore approaches such as external control arms and modeling techniques, including digital twins, particularly in well-characterized disease areas.”
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