Researchers from Saudi Arabia studied the quality and quantity of clinical trials in the strategically, culturally, economically and spiritually important Middle Eastern nation.  The researchers, from Sulaiman Al Rajhi Colleges and Qassim University, reveal that the quality of randomized controlled trials from the nation is unknown since most research is observational studies.

The researchers scoured PubMed, SCOPUS and Cochrane were searched for studies published from Saudi Arabia up till February 2018. The team was 422 records were identified and assessed in multiple domains using the Cochrane Collaboration Risk of Bias Tool.

https://www.ncbi.nlm.nih.gov › books › NBK132494 › bin › appf-fm1

Findings

The team found that the majority of trials (57%) were published during the period of 2010-2018 and they included a high risk of bias was present for blinding.  The Saudi investigators couldn’t assess biases due to lack of information in the domains of randomization (54%), allocation concealment (44%), and blinding of outcome assessment (57%).  Factoring in all the domains the researchers conclude that 0% of the trials have low risk, 39% had high risk and 61% had an unclear risk of biases. As reported in Science Direct, a higher proportion of high-risk trials had considerable intervention effect than unclear-risk trials (79% vs. 67%).

Consequently, the team was required to conclude that the volume and quality of trials in Saudi Arabia were slow.  They concluded that more high-quality randomized controlled trials are warranted to address chronic diseases in the nation.

Saudi Research Site Participants in Study

This report was produced by an investigator from the College of Medicine, Sulaiman Al Rajhi Colleges and College of Medicine, Qassim University both in Saudi Arabia.

College of Medicine, Sulaiman Al Rajhi Colleges

Abbreviated SRC, is a private, non-profit, research university comprising three graduate colleges including 1) Medicine, 2) Nursing and 3) Applied Medical Sciences as well as a state-of-the-art University Hospital.  These colleges were founded by the Sulaiman Bin Abdul Aziz Al Rajhi Charitable Foundation and they are located in Bukayriyah, Saudi Arabia.

College of Medicine, Qassim University

A public university in the Al-Qassim Province of Saudi Arabia. Established in 2004 jointly between King Saud University and Imam Muhammad ibn Saud Islamic University, each of which used it as its Qassim campus.

Clinical Trials Count in Saudi Arabia

TrialSite News did a brief review of clinical trials in Saudi Arabia based on data in Clinicaltrials.gov.  At present, there are 155 active clinical trials in Saudi Arabia.  Of the 155, 65 studies are sponsored by industry; 71 are sponsored by academic medical centers or local or regional government and the rest other sources.

In 2017, a study was commissioned by King Saud Medical City Ministry of Health in Riyadh which concluded that by 2017 405 clinical trials had been registered in total in the Kingdom. The studies fell into 22 different therapeutic areas the top four (4) being 1) neoplasms (92), circulatory system disease (57), endocrine, nutritional and metabolic diseases (46) and finally respiratory diseases (25). As far as stages 52% were Phase IV and 28% were Phase III.  The investigators concluded, much like the more recent study, that for a country of its size and population the level of clinical trial activity has been limited. The emphasis has been on post-marketing Phase IV trials.

Saudi Pharmaceutical Industry

A recent industry report highlighted in the Saudi Gazette revealed that the pharmaceutical industry in Saudi Arabia was approaching $10.74 billion in value by 2023. IQVIA reports that the Kingdom’s pharmaceutical market will probably grow at a compound annual growth rate (CAGR) of 5.5% until 2023. One of the region’s largest pharmaceutical markets, its growth can be attributed to its growing population—currently at 34 million (32% under 14)—and growing life expectancy (69 in 1990 and over 75 today).  Moreover, Saudi Arabia faces health delivery challenges as the population can be segmented into highly densely populated urban centers (Riyadh and Jeddah) and isolated rural areas. 

Clinical trial planning in Saudi Arabia should consider the demographic reality of on the one hand highly dense populations and on the other hand far-flung rural locations—making telemedicine and other decentralized clinical research options subject for consideration.

Rise in Disease

The Saudi population, much like many other developing or developed nations, is headed toward a health care crisis created in part by lifestyle dynamics associated with wealth.  Many growing non-communicable diseases such as cardiovascular, cancer, diabetes and obesity require long-term treatment and medication. Over 35,000 children have been diagnosed with Type 1 diabetes making the Kingdom’s population at high risk for growing rates of this disease.

Lead Research/Investigators

Ahmad Mamoun Rajab, College of Medicine, Sulaiman Al Rajhi Colleges, P.O. Box 777, Al Bukayriah, Qassim, 51941, Saudi Arabia

Abdulmalik Hamza, College of Medicine, Sulaiman Al Rajhi Colleges, P.O. Box 777, Al Bukayriah, Qassim, 51941, Saudi Arabia

Roshdi Kotaiba Aldairi, College of Medicine, Sulaiman Al Rajhi Colleges, P.O. Box 777, Al Bukayriah, Qassim, 51941, Saudi Arabia

Mohamad Mahmoud Alaloush, College of Medicine, Sulaiman Al Rajhi Colleges, P.O. Box 777, Al Bukayriah, Qassim, 51941, Saudi Arabia

Juliann Saquib, College of Medicine, Qassim University, P.O. Box 6655, Buraidah, Qassim, 51452, Saudi Arabia

Nazmus Saquib, College of Medicine, Sulaiman Al Rajhi Colleges, P.O. Box 777, Al Bukayriah, Qassim, 51941, Saudi Arabia

Source: Science Direct

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