The Characteristics of Clinical Studies Submitted to the Saudi Food and Drug Authority from 2009 until 2020

Aljawadi, Mohammad; Aldhahri, Renad A.; Almetwazi, Mansour; Arafah, Azher; Khoja, Abdullah T

doi:10.1016/j.jsps.2021.08.013

Cited by 3 publications

(2 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For instance, the US ClinicalTrials.gov had 100,208 registered studies in 2010, which increased to 362,545 registered studies in 2020 [5]. The number of clinical trials registering at the International Clinical Trials Registry Platform (ICTRP) had significantly increased from 19,287 registered studies in 2005 increased to 25,544 registered studies in 2010 and 8,192,470 registered studies in 2020 [6].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Aljahmi,

Balkhi,

Al Hassan

et al. 2023

Saudi J Health Syst Res

View full text Add to dashboard Cite

Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.

show abstract

Section: Introductionmentioning

confidence: 99%

“…To our knowledge, one study describes the characteristics of drug clinical trials in Saudi Arabia [19]. The study got its data from the publicly available drug clinical trials list, which has an incomplete listing of studies registered before 2013 because the system was paper based.…”

Section: Introductionmentioning

confidence: 99%

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

Aljahmi,

Balkhi,

Al Hassan

et al. 2023

Saudi J Health Syst Res

View full text Add to dashboard Cite

show abstract

Interethnic Differences in Drug Response: Projected impact of Genetic Variations in the Saudi Population

Alsultan,

Alalwan,

Alshehri

et al. 2023

Pharmacogenomics

View full text Add to dashboard Cite

Ethnicity is known to have an impact on drug responses. This is particularly important for drugs that have a narrow therapeutic window, nonlinearity in pharmacokinetics and are metabolized by enzymes that demonstrate genetic polymorphisms. However, most clinical trials are conducted among Caucasians, which might limit the usefulness of the findings of such studies for other ethnicities. The representation of participants from Saudi Arabia in global clinical trials is low. Therefore, there is a paucity of evidence to assess the impact of ethnic variability in the Saudi population on drug response. In this article, the authors assess the projected impact of genetic polymorphisms in drug-metabolizing enzymes and drug targets on drug response in the Saudi population.

show abstract

Views from Multinational Pharmaceutical Companies on Allocation of Clinical Trials in Saudi Arabia—Qualitative Study

Aloudah,

Shaman

2024

Pharmacy

View full text Add to dashboard Cite

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.

show abstract

The Characteristics of Clinical Studies Submitted to the Saudi Food and Drug Authority from 2009 until 2020

Cited by 3 publications

References 26 publications

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

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

Interethnic Differences in Drug Response: Projected impact of Genetic Variations in the Saudi Population

Views from Multinational Pharmaceutical Companies on Allocation of Clinical Trials in Saudi Arabia—Qualitative Study

Contact Info

Product

Resources

About