Challenges Facing Clinical Trial Units in the MENA Region: A Scoping Review

Clinical Trial Units (CTUs) are essential for the conduct of high-quality clinical trials; however, within the Middle East and North Africa (MENA) region, evidence describing the challenges affecting their establishment, operation, and sustainability remains fragmented and unsynthesized. The objective of this study is to systematically map and characterize the challenges facing clinical trials and CTUs across MENA countries. This study is designed as a scoping review guided by the Population–Concept–Context (PCC) framework, where the population includes CTUs and stakeholders involved in clinical trial conduct, the concept focuses on challenges and barriers, and the context is clinical research settings within the MENA region. The review will be conducted and reported in accordance with the PRISMA-ScR guidelines. Eligible sources will include full-text, peer-reviewed studies (qualitative, quantitative, and mixed-methods) and review articles published in English from 2000 onwards, reflecting the period during which formal clinical research infrastructure began to emerge in parts of the MENA region. Relevant grey literature will also be considered. Studies reporting challenges related to regulatory, operational, infrastructural, workforce, financial, or sociocultural aspects of clinical trial conduct in MENA countries will be included. Conference abstracts without available full text, editorials lacking substantive analysis, preclinical or animal studies, and studies conducted exclusively outside the MENA region will be excluded. A descriptive and thematic analysis will be undertaken to chart and categorize reported challenges, consistent with scoping review methodology. The literature search will be conducted across multiple electronic databases, including PubMed, Scopus, and Embase. The primary outcomes of interest are the types and domains of challenges reported, their distribution across MENA countries, and gaps in the existing evidence to inform future research, policy development, and capacity-building initiatives.