Bridging the clinical trial gap in Saudi Arabia: a multi-stakeholder conference-based consensus on strategic initiatives for global competitiveness and patient inclusion.

Abstract

The clinical trial ecosystem of Saudi Arabia has advanced significantly, with innovative industry-sponsored clinical trials (iCTs) growing by 27% from 2018 to 2023, reaching 51.4% in the first half of 2025. However, the Kingdom remains underrepresented in global research. This study aimed to quantify this gap and develop strategies to enhance Saudi Arabia's competitiveness. A mixed-methods research design was employed. Phase 1 involved a quantitative landscape analysis of historical and current iCT data (2016-2023) using the LongTaal Clinical Trial Informatics platform. Phase 2 involved a qualitative assessment of expert input derived from two national clinical trial conferences (2022 and 2024), in which expert panel discussions and documented outputs were used to contextualize findings and inform strategic recommendations. In 2023, Saudi Arabia's iCT market share was < 0.06%, significantly lower than its ~ 0.9% share of global pharmaceutical consumption. This 16-fold disparity highlights a critical lack of patient representation. Economic modelling indicates that achieving parity could increase annual research and development (R&D) investment from ~ USD 46 million to over USD 740 million. Insights derived from conference-based expert discussions highlighted regulatory timelines, infrastructure fragmentation, and insufficient incentives as primary barriers. To bridge this gap, the authors propose operationalizing a centralised national body to serve as a "one-stop shop" for global sponsors. Strategic priorities include harmonizing regulatory timelines to 6 months, establishing distributed Centres of Excellence, and implementing direct R&D financial incentives. These measures are essential to ensuring Saudi patients are adequately represented in the development of novel pharmaceuticals.