Using Genomic Data in Personalized Oncology Medicine: An Exploratory Expert-Elicitation Study with Narrative Regulatory Mapping of Regulations, Implementations, and Challenges in Saudi Arabia.

BACKGROUND/OBJECTIVES: Personalized medicine represents a transformative approach to healthcare in Saudi Arabia. However, a significant research gap exists regarding the specific regulatory, implementation, and practical challenges of integrating genomic data into personalized oncology care in the Saudi context. We aimed to conduct an exploratory assessment of the current regulatory landscape, practices, and challenges related to genomic data use in personalized oncology in Saudi Arabia and to identify regulatory and practical gaps, propose actionable solutions, and outline future directions for enhancing genomic integration into cancer treatment. METHODS: A mixed-methods exploratory design incorporating qualitative expert interviews and a narrative regulatory review was adopted. RESULTS: We integrated qualitative insights from four subject-matter experts with evidence from a non-systematic literature review and a narrative review of regulatory documents issued by Saudi stakeholders and international authorities. The findings identified six key themes comprising (1) the emerging role of personalized medicine in cancer care, (2) current practice and Saudi genomic initiatives, (3) regulatory and policy gaps, (4) ethical and data privacy concerns, (5) infrastructure gaps and genetic testing barriers, and (6) stakeholder collaboration and data sharing, with subthemes including healthcare providers' skills, patient awareness, expert recommendations, future perspectives, and a descriptive regulatory comparison. However, these themes represent preliminary findings requiring further validation. CONCLUSIONS: We provide preliminary insights highlighting significant challenges in integrating genomic data into personalized oncology in Saudi Arabia, emphasizing the need for a national regulatory framework, clear guidelines, robust infrastructure, and strong stakeholder collaboration. These findings offer a foundational roadmap for future research and policy development.