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Introduction: Clinical trials are crucial for advancing medical knowledge and improving healthcare outcomes. Despite an increase in research publications in Saudi Arabia, clinical trial productivity has lagged behind. Understanding the barriers to conducting clinical trials in Saudi Arabia is essential. This study aims to explore the challenges and propose solutions for improving clinical trial capacity in the Kingdom. Specifically, we aim to develop national strategies to enhance clinical trial infrastructure, identify educational needs, and suggest ways to strengthen research education and training in Saudi Arabia. Methods: The study utilized a qualitative research design with a grounded theory approach. Participants were recruited through purposive sampling, including clinical trial professionals from Riyadh, Jeddah, and Al Khobar, who participated in three half-day workshops. Discussions focused on required skillsets, barriers to conducting trials, improvement recommendations, gaps in research education, and strategies for the Saudi National Institute of Health (SNIH) to support clinical trials. Data were collected through pre-workshop surveys and focus group discussions, and thematic analysis was employed to identify common themes. Results: A total of 35 participants, mainly from the government sector (67%), attended the workshops. Physicians represented the largest professional group (31%), with the majority being Saudi nationals (83%) and engaged in clinical practice (65%). The study identified key challenges, including limited resources (82%), inadequate infrastructure (82%), time constraints (80%), and insufficient funding (80%). While satisfaction with educational programs was mixed, a need for improved infrastructure and support for clinical trials in Saudi Arabia was evident. The focus group discussions further highlighted the importance of research competency, identifying 11 essential domains such as research methodology, data management, and project leadership. Nine major challenges were noted, including funding, infrastructure, and collaboration deficits. A total of 38 recommendations were proposed to address these challenges and enhance the national clinical trial ecosystem. Conclusions: This study underscores the importance of addressing the challenges in conducting clinical trials in Saudi Arabia through targeted educational programs, training initiatives, and enhanced support from the SNIH. By implementing strategies that focus on funding, resources, training, and collaboration, Saudi Arabia can significantly advance its clinical trial landscape, improve research quality and efficiency, and position itself as a leader in global health research. [ABSTRACT FROM AUTHOR]

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