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<p>Metabolic dysfunction associated steatotic liver disease (MASLD) and metabolic dysfunction associated steatohepatitis (MASH) are accelerating global priorities, yet pivotal clinical trial activity remains concentrated in North America and Europe despite substantial burden in the Middle East and North Africa (MENA). Building on prior work quantifying MENA underrepresentation, we provide a policy and operational analysis informed by contemporary epidemiological, regulatory, and clinical trial literature and practical experience in trial delivery. We argue that underselection is driven less by scientific feasibility than by predictable, modifiable operational constraints. Key barriers include prolonged and fragmented contracting and budget negotiations, limited and inconsistent endpoint delivery capacity (imaging, noninvasive tests, and biopsy workflows), uneven pharmacy infrastructure for investigational product handling, shortages of stable research staffing with protected time, and variable ethics and regulatory review pathways. Commercial incentives to prioritize FDA and EMA approval in high profitability markets can reinforce these patterns, raising scientific and ethical concerns when high burden populations remain underrepresented. We propose actionable reforms across stakeholders, including earlier feasibility that funds readiness, standardized contracting pathways with clear timelines, shared regional endpoint support for pathology and imaging, and regulatory reliance models that reduce redundant review without weakening protections. Strengthening trial delivery as a measurable health system function is essential for MENA inclusion and for global credibility of emerging MASLD and MASH therapeutics.</p>

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Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change

  • 期刊论文

  • 发表日期：

    2026年4月25日

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  • Mohamed El-Kassas,
  • Khalid M. AlNaamani,
  • Khalid Alswat,
  • Zobair M. Younossi

摘要

Metabolic dysfunction associated steatotic liver disease (MASLD) and metabolic dysfunction associated steatohepatitis (MASH) are accelerating global priorities, yet pivotal clinical trial activity remains concentrated in North America and Europe despite substantial burden in the Middle East and North Africa (MENA). Building on prior work quantifying MENA underrepresentation, we provide a policy and operational analysis informed by contemporary epidemiological, regulatory, and clinical trial literature and practical experience in trial delivery. We argue that underselection is driven less by scientific feasibility than by predictable, modifiable operational constraints. Key barriers include prolonged and fragmented contracting and budget negotiations, limited and inconsistent endpoint delivery capacity (imaging, noninvasive tests, and biopsy workflows), uneven pharmacy infrastructure for investigational product handling, shortages of stable research staffing with protected time, and variable ethics and regulatory review pathways. Commercial incentives to prioritize FDA and EMA approval in high profitability markets can reinforce these patterns, raising scientific and ethical concerns when high burden populations remain underrepresented. We propose actionable reforms across stakeholders, including earlier feasibility that funds readiness, standardized contracting pathways with clear timelines, shared regional endpoint support for pathology and imaging, and regulatory reliance models that reduce redundant review without weakening protections. Strengthening trial delivery as a measurable health system function is essential for MENA inclusion and for global credibility of emerging MASLD and MASH therapeutics.