Abstract
Clinical trials conducted by pharmaceutical companies are essential for bridging local research efforts with broader populations, facilitating the transfer of valuable insights and solutions. This study aimed to explore the barriers and facilitators affecting clinical trials in Saudi Arabia from the perspective of key personnel within the pharmaceutical industry and Contract Research Organizations (CROs). We conducted in-depth semi-structured interviews with nine participants, which provided a holistic understanding of the intricate dynamics shaping the landscape of clinical trials in the country. The analysis revealed three prominent themes: operational challenges, complexities in navigating approval hurdles, and the unique value proposition for conducting clinical trials in Saudi Arabia. The participants expressed pride in the local infrastructure but acknowledged existing flaws, particularly in regulatory processes that contribute to delays in trial initiation. They emphasized the importance of conducting clinical trials in areas such as diabetes, crowd management during pilgrimages, and rare diseases, which are prevalent in the region. Despite the limited number of clinical trials registered (354 from 2009 to 2020, with only 1% being phase 1 studies), Saudi Arabia's total pharmaceutical market exceeds SAR 13 billion, positioning it as the largest market in the region. Stakeholders recognized the country's potential as a research hub, particularly within the Gulf Cooperative Council (GCC) region. However, to attract more trials and enhance the medical research landscape, it is crucial to address the identified barriers, streamline processes, and improve stakeholder alignment. The findings highlight the need for targeted interventions to overcome these challenges and leverage Saudi Arabia's investments in healthcare infrastructure since its transformation program launched in 2010. By enhancing the regulatory environment and fostering collaboration among stakeholders, Saudi Arabia can solidify its role as a key player in international clinical research.