Middle East Disruption Impacts 6.7% of Global Clinical Trials, With Phase 3 Studies Most Affected

The ongoing disruption in the Middle East is affecting a meaningful portion of global clinical research, with 6.7% of active trials and thousands of investigator sites exposed to regional instability, new insights from Phesi reveal.¹

The report evaluated 65,061 actively recruiting clinical trials across 186 countries and found that 4361 studies are impacted by the disruption. Of the 356,699 recruiting investigator sites worldwide, 7958 (2.2%) are located in affected areas, underscoring the geographic reach of the issue and its implications for trial continuity.

Late-stage studies appear to be particularly vulnerable. Phase 3 trials account for the highest number of impacted sites, totaling 2732, according to the report. These trials are typically larger, more complex, and involve significant financial investment and patient participation, making them especially sensitive to interruptions.

“Clinical development has become deeply interconnected,” said Gen Li, PhD, founder and CEO, Phesi, in a statement. “When disruption occurs, the impact extends beyond individual sites, particularly in high-priority disease areas such as oncology. 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.”

Geographically, the analysis identified Turkey, Israel, and Egypt as having the highest concentrations of affected investigator sites. These countries serve as important hubs for global clinical research, contributing to patient recruitment and data generation across multiple therapeutic areas.

Oncology trials account for a substantial share of the disruption, reflecting both the scale of cancer research globally and its reliance on multinational trial networks. Among specific indications, non–small cell lung cancer emerged as the most affected, followed by breast cancer. Additional therapeutic areas experiencing impact include heart failure, multiple myeloma, and Crohn disease—highlighting that the disruption spans both oncologic and chronic conditions.

The analysis also underscores the extent to which major pharmaceutical companies are exposed. All top 10 global pharmaceutical organizations maintain a considerable presence in the affected region, with some reporting between 400 and 500 investigator sites. This level of involvement increases the risk that regional instability could ripple across global development pipelines, potentially delaying timelines and complicating regulatory pathways.

Beyond immediate operational challenges, the findings point to how clinical trials must be managed in an increasingly uncertain global environment.

In addition to the direct operational risks posed by geopolitical disruption, broader shifts in how clinical trials are managed highlight the need for adaptive trial designs and oversight strategies.² A comprehensive review of risk‑based monitoring (RBM) in clinical trials published in Therapeutic Innovation & Regulatory Science emphasizes that emergent events—including the COVID‑19 pandemic—prompted a rapid transition from traditional on‑site oversight to remote, centralized, and data‑driven monitoring practices. This evolution in monitoring approaches is intended to enhance patient safety, preserve data integrity, and maintain continuity of trial operations when traditional site access is restricted by external events. The adoption of RBM components such as remote monitoring and centralized analytics can help sponsors detect protocol deviations and quality issues in real time, even during periods of widespread disruption, reinforcing the importance of flexible, risk‑informed trial frameworks in the face of unpredictable global challenges.

“Disruption and uncertainty are becoming a structural feature of clinical development,” said Li in the statement.¹ “The priority is not only to respond, but to proactively use data to understand exposure and mitigate risk. Such periods of disruption reinforce the need for a precise, data-driven approach to development. 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.”

Phesi’s findings highlight the critical importance of maintaining patient safety and data integrity while ensuring continuity in clinical research. As global trials become increasingly interconnected, the ability to anticipate and respond to disruption will be essential for sustaining progress in drug development and delivering new therapies to patients.

References

1. New Phesi data shows 6.7% of global clinical trials impacted by Middle East disruption. News release. Phesi. April 1, 2026. Accessed April 1, 2026. https://www.phesi.com/news/new-phesi-data-shows-6-per-cent-of-global-clinical-trials-impacted-by-middle-east-disruption/

2. Barnes B, Stansbury N, Brown D, et al. Risk-based monitoring in clinical trials: past, present, and future. Ther Innov Regul Sci. 2021;55(4):899-906. doi:10.1007/s43441-021-00295-8