An analysis of 65,061 globally recruiting clinical trials across 186 countries finds that 4,361 studies, equivalent to 6.7% of all active trials, are impacted by disruption in the Middle East.
The research, conducted by data analytics firm Phesi, found that across a total of 356,699 recruiting investigator sites, 7,958, or 2.2%, are in the affected region, with Phase III trials accounting for the highest number of impacted sites at 2,732.
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The highest number of sites experiencing disruption are located in Turkey, Israel and Egypt, with oncology trials accounting for a substantial proportion of impacted activity. Additional impact is seen across conditions, including heart failure, multiple myeloma and Crohn’s disease.
The analysis also finds that large pharmaceutical companies have a substantial footprint in the region, with some organisations having between 400 and 500 sites in the Middle East.
Dr Gen Li, founder and CEO, Phesi, said: “Clinical development has become deeply interconnected. When disruption occurs, the impact extends beyond individual sites, particularly in high-priority disease areas such as oncology. The impact on Phase III 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.”
Li added that while disruption is becoming a “structural feature of clinical development”, considering Covid-19 and the Russia-Ukraine war, sponsors should consider ways 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 modelling techniques, including digital twins, particularly in well-characterised disease areas,” Li added.
Analysis from GlobalData’s Strategic Intelligence Team identifies several negative impacts should a prolonged war continue with disruption of shipping through the Strait of Hormuz and flights.
One impact is that war-driven rises in security spending globally could leave countries with less funds for public sector healthcare spending and reimbursement of medicines.
Disruption of flights, shipping and supply poses risks to the supply of medicines and Active Pharmaceutical ingredients (APIs) to Middle East markets, as well as potentially impacting local production. There is also potential for disruption of pharmaceutical exports from India and China to the MENA region.
Finally, the rise in oil and gas prices could increase the cost of drug production globally.
The US Food and Drug Administration (FDA) released guidance on disaster preparedness in clinical trials in September 2023. The FDA guidance, named “considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies”, discusses the ways in which those involved in trials can overcome a variety of barriers. The guidance informs sponsors to make considerations dependent on the necessity of the trial, the ability to provide patients with an investigational product (IP), changing trial design while keeping the integrity of the trial and most importantly, ensuring patient safety.
