A Retrospective Descriptive Analysis of the Saudi Clinical Trials Registry from 2010 to 2021

Abstract

<b><i>Introduction:</i></b> To date, the number and type of drug trials undertaken in Saudi Arabia have yet to be assessed comprehensively. This study aims to give a holistic view and describe the patterns of drug clinical studies registered and conducted in Saudi Arabia from 2010 to 2021, including the most common study phases, study site distribution, most commonly studied diseases, study sponsorship, and statistics about contract research organization (CRO) use. <b><i>Methods:</i></b> A descriptive cross-sectional study of all completed drug clinical study applications submitted to the Saudi Clinical Trials Registry at the Saudi Food and Drug Authority (SCTR-SFDA) database from February 2010 to December 2021. <b><i>Results:</i></b> The SCTR received 477 drug clinical trial applications from February 2010 to December 2021. Of these, 151 (31.7%) were accepted and completed their studies, while 214 (44.9%) were accepted but had ongoing studies. Most submitted trials (62.7%) were international multicenter studies, while 37.3% were conducted only in Saudi Arabia. Phase 3 and 4 trials were the most submitted study phases, followed by phase 2 and phase 1. The most studied therapeutic areas were oncology, endocrinology/metabolism, cardiology, and infectious diseases. Pharmaceutical companies sponsored most studies (62.7%) compared to local investigator (non-pharmaceutical) studies (37.3%). The Riyadh region had the most clinical study sites, followed by the Makkah region and the Eastern Province region. Of the 151 completed studies, 46.4% were published, with multinational studies being more likely to be published than local studies. Pharmaceutical companies were more likely to sponsor multinational studies, while studies conducted in Saudi Arabia only were more likely to be sponsored by local investigators. Only 33.3% of the studies employed CRO services, with 6.5% of studies conducted locally in Saudi Arabia using CROs and 26.8% of studies delegated CROs for multinational studies. <b><i>Conclusions:</i></b> SCTR has shown an increase in evaluated applications over time. The number of completed trial reviews in Saudi Arabia had increased from 18 in 2010 to 55 in 2021. This indicates the SFDA’s ability to monitor and regulate more studies in the future, with the majority of submitted trials being international multicenter studies. The most studied therapeutic areas were oncology, endocrinology/metabolism, cardiology, and infectious diseases, with pharmaceutical companies sponsoring most studies. The Riyadh region had the most clinical study sites, and only a third of the studies employed CRO services.