Arab Omaima O, Aldayan Mohammed, Almowaizri Khalid, Alghamdi Ahmad, Alghamdi Jahad, Alharf Adel
Clinical Trials Department Benefit and Risk Assessment Executive Directorate Drug Sector - Saudi Food and Drug Authority, Riyadh, 13513- 7148, Saudi Arabia.
Ther Innov Regul Sci. 2025 Mar;59(2):295-303. doi: 10.1007/s43441-024-00731-5. Epub 2024 Dec 26.
The Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good Clinical Practice (GCP) to safeguard clinical trial integrity and protect the rights, safety, and welfare of study participants. These inspections ensure that trials are conducted in compliance with GCP and applicable laws.
The study aims to provide a description of GCP inspection findings, analyze their impact on the clinical trial ecosystem, and provide recommendations to improve clinical trial conduction in Saudi Arabia.
A review was conducted on inspection reports, with two senior independent inspectors examining, collecting, and categorizing the data. Descriptive statistics were used to summarize the categorical variable via frequency distributions.
A total of 131 GCP inspections were performed between 2017 and 2023, totaling 722 observations from 116 (88.5%) inspection visits. The remaining 15 (11.5%) inspection visits recorded no observations. The highest number of visits were conducted in contract research organizations (CRO) (n = 50; 38.2%) with 118 observations, followed by clinical investigator sites (n = 46; 35.1%) with 313 observations, then bioequivalence (BE) centers (n = 33; 25.2%) with 256 observations, and the last 2 (1.5%) visits were conducted in phase I clinical trial units with 35 observations.
This study assesses GCP inspection reports and examines the types of deficiencies and their grades in each area. Observation categories and grades were found to vary by organization type, which indicates the need for specific action plans addressing each organization type separately. This report provided recommendations based on the most common findings to assist researchers and sponsors when conducting clinical trials in Saudi Arabia.
沙特食品药品管理局（SFDA）按照《药物临床试验质量管理规范》（GCP）进行检查，以维护临床试验的完整性，并保护研究参与者的权利、安全和福祉。这些检查确保试验按照GCP和适用法律进行。
本研究旨在描述GCP检查结果，分析其对临床试验生态系统的影响，并提出改进沙特阿拉伯临床试验开展的建议。
对检查报告进行回顾，由两名资深独立检查员检查、收集和分类数据。使用描述性统计通过频率分布总结分类变量。
2017年至2023年期间共进行了131次GCP检查，来自116次（88.5%）检查访问的观察结果共计722项。其余15次（11.5%）检查访问未记录观察结果。访问次数最多的是合同研究组织（CRO）（n = 50；38.2%），有118项观察结果，其次是临床研究者站点（n = 46；35.1%），有313项观察结果，然后是生物等效性（BE）中心（n = 33；25.2%），有256项观察结果，最后2次（1.5%）访问是在Ⅰ期临床试验单位，有35项观察结果。
本研究评估了GCP检查报告，并检查了每个领域的缺陷类型及其等级。发现观察类别和等级因组织类型而异，这表明需要针对每种组织类型分别制定具体的行动计划。本报告根据最常见的发现提出了建议，以协助研究人员和申办者在沙特阿拉伯进行临床试验。
