Clinical Trials in Saudi Arabia with Prof. Majed Al Jeraisy

Country and site selection for clinical trials is an important aspect of clinical operations. When it comes to country selection for industry sponsored studies, the default options generally tend to be the United States, United Kingdom, or countries in Europe. However, if a Sponsor decides to expand outside these default geographical areas, it may be possible expedite patient recruitment while getting access to high quality data. One such country to consider when conducting global clinical trials is Saudi Arabia.

Saudi Arabia’s modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. 

To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show.  

Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, College of Pharmacy, King Saud Ben Abdulaziz University for Health Sciences and Pediatric Clinical Pharmacy Consultant in King Abdullah Specialized Children Hospital. He was appointed as the chairman of the research office at King Abdullah International Medical Research Center (KAIMRC)

in 2007 and was appointed as the Director of Clinical Trial Services in 2018. 

Professor Majed Al Jeraisy obtained his Bachelor degree in Pharmaceutical science and Master of Science in Clinical Pharmacy from King Saud University, Riyadh. He then obtained his Doctor of Pharmacy degree from the University of Tennessee, USA, followed by two years of residency and fellowship in pediatric pharmacotherapy from the same place. 

Dr. Al Jeraisy has also completed a Master of Science degree in Medical Education from King Saud ben Abdulaziz University for Health Sciences, Riyadh. He is a reviewer of local and international peer reviewed journals, also he has authored and co-authored numerous and relevant scientific research projects in the field of Pediatrics, Pharmacotherapy, General Medicine, Biochemistry, Pharmacology and Toxicology that were published in reputable Journals.

Please join me in welcoming Professor Majed Al Jeraisy on the Clinical Trial Podcast. 

Sponsor(s):

This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 37,000 study sites, sponsors, and CROs in 90 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com

This podcast is brought to you by Slope Clinical. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

SELECTED LINKS FROM THE EPISODE:

Connect with Prof. Majed Al Jeraisy

Social Media: LinkedIn

Company*: King Abdullah International Medical Research Center (KAIMRC) (Official Website, Wikipedia)

Other Projects: Google Scholar

*at the time of this interview

Dr. Majed Al Jeraisy – LinkedIn Profile

Dr. Majed Al Jeraisy King Saud bin Abdulaziz University for Health Sciences Profile

King Abdullah International Medical Research Center (KAIMRC)

King Saud bin Abdulaziz University for Health Sciences (KSAU-HS)

King Abdullah Specialist Children’s Hospital

King South University Riyadh Pharmacy Program

University of Tennessee Doctorate of Pharmacy Program

Saudi Food and Drug Agency (SFDA)

Regulations and Requirements for Conducting Clinical Trials in Saudi Arabia

National Committee of Bioethics (NCBE)

Saudi Health Council

Kingdom of Saudi Arabia Ministry of Health (MoH)

Council of Health Insurance Saudi Arabia

National Institute of Health – US (NIH)

National Health Service – UK (NHS)

Food and Drug Administration – US (FDA)

US Centers for Disease Control and Prevention (CDC)

Public Health Authority (PHA) of Saudi Arabia

NUPCO – Unified Procurements in Saudi Arabia

Saudi National Institute of Health (Saudi NIH)

Research, Development, and Innovation Authority (RDIA)

European Medical Agency – EU (EMA)

Good Clinical Practice (GCP)

Institutional Review Boards (IRB)

Seoul National University – South Korea

Diabetes

Lukemia

Ramadan 

Courier services – DHL, Fedex, Aramex

Show Notes:

[0:20] Dr. Al Jeraisy background

• Associate Professor of Pharmacy Practice, College of Pharmacy King Saudi Ben Abdul Aziz University of Health Sciences
• Pediatric Clinical Pharmacy consultant at King Abdullah Specialized Children’s Hospital
• Chairman of Research Office at King Abdullah International Medical Research Center (KAIMRC)
• BA and MA in Pharmaceutical Sciences from King Saudi University Riyadh 
• Doctorate of Pharmacy from University of Tennessee
• Master of Science in Medical Education from King Saudi Abdul Aziz University for Health Sciences Riyadh 

[2:38] Sponsor Message: This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com 

[4:16] Dr. Al Jeraisy joins and provides background on the Saudi Arabia Health System

• First clinical trials in Saudi Arabia started in the 1970s
• English is officially the spoken language in hospital settings
• Patients speak English and/or Arabic
• Very high standard of healthcare system quality
• Many physicians study medicine abroad
• Healthcare is free for all Saudi nationals
• Follows North American Guidelines for many issues, for example obesity 

[11:06] Clinical Trial Regulatory Requirements in Saudi Arabia

• Managed by the Saudi Food and Drug Authority (SFDA) – Established in 2005
• Previously managed by the Ministry of Health (MoH)
• In the process of sending scholars abroad to get informed about other health regulatory agencies to develop the SFDA
• Hybrid system of US FDA and European Medical Agency (EMA)
• Trial guidelines similar to Good Clinical Practice (GCP) guidelines

[13:31] Protocol Approval Guidelines in Saudi Arabia

• Normally if approved by ethics committee, Saudi Food and Drug Authority (SFDA) will accept protocol
• Comfortable with minor regional amendments if approved by ethics committee
• Can do SFDA and ethics submissions in parallel but SFDA approval requires ethics approval
• 60 day approval timelines for SFDA and Ethics committees per guidelines
• Clinical Trial Agreements (CTA) do not go through SFDA but still required for study
• Guidelines on SFDA website under Rules and Regulations of Clinical Trials

[18:36] Clinical Trial Selection in Saudi Arabia

• Have to have local representation in Saudi Arabia – Can be local or registered international CRO or sponsor local office
• Similar to rest of world: feasibility questionnaire, PI/ site selection, signing of confidential disclosure agreement (CDA), and protocol submission
• Limited site options within the country that are qualified for clinical trials
• Using SFDA or Clinical Trial Registry is a good way to identify sites that qualify

[23:00] National Bioethics Committee and IRBs

• National Committee of Bioethics (NCBE) monitor the performance of local IRBs
• Audit IRBs to ensure adherence to bylaws
• Submissions go through local IRBs not central or national

[25:00] Medical product shipments

• Site requests import permits
• Conditional that upon receiving investigational medical product that they do not use until IRB approval
• Import request document is sent to SFDA who provides approved permit
• Straightforward: Saudi Arabi has DHL, Fedex and Aramex

[26:56] Ethical Considerations for Clinical Trials in Saudi Arabia

• Follow international informed consent guidelines
• 21 elements for international informed consent form
• Informed Consent Form (ICF) requires translation to Arabic which IRB is meticulous about

[29:00] Ramadan and Cultural Elements in Study Considerations

• Patients will continue participation on studies during Ramadan
• No restrictions for women to participate in studies
• In surveys 69% of Saudi people say they would participate in phase 1, phase 2, or phase 3 clinical trials

[33:02] Other Public Health Agencies in Saudi Arabia

• “Weqaya” – similar to the Center for Disease Control (CDC) in the United States 
• Not involved in trials unless you do a trial with them
• NUPCO – Nationalized Formulary 
• Saudi National Institute of Health (Saudi NIH): New agency meant to facilitate clinical trials

[38:34] Sponsor Message: Florence Heatlhcare (https://florencehc.com/) & Slope Clinical (https://www.slopeclinical.com/)

[38:34] Other Public Health Agencies in Saudi Arabia 

• ublic health insurance provider and regulator in Saudi Arabia
• Provides insurance certificates for clinical trials

[43:00] Clinical Trail Recruitment in Saudi Arabia

• Rare and Genetic diseases are fairly common in the country compared to other regions
• Diabetes is very prevalent with 35% of the population affected by next year
• Cardiac disease is also fairly common in region
• Colon, breast and leukemia are most common types of cancer

[47:15] Clinical Trial Costs

• Relatively fair market value for costs when compared to other regions
• Fees align with fees incurred when doing trials in other regions

[49:12] Areas that sponsors should pay close attention to

• Autoimmune disease with novel therapies therapies like monoclonal antibodies and gene therapy are doing well
• SFDA allows hospitals to request importing of medicine approved internationally
• Data quality is very important and hospitals do very well with recruitment and avoiding protocol deviations

[55:41] Study challenges in Saudi Arabia

• Most sites that close studies early do so because they fail to recruit or struggle to find patients that meet the inclusion/exclusion criteria
• Sometimes face similar issues to other regions where hospital staff does not have bandwidth to support study

[57:21] Research Coordinators in Saudi Arabia

• At King Abdullah International Medical Research Center gap analysis is used to determine how many coordinators are needed for providers
• Actively trying to improve the career tracks for people who start as research coordinators

[59:41] Dr. Al Jeraisy’s experience as the chairman at KAIMRC

• Supports projects on all ends: Meets with sponsors, meets with PIs, meets with sponsors
• Helps to facilitate projects success
• Goal by end of 2024 was to increase clinical trials by 30%
• Actively working to speed up the turn around time of Clinical Trial Agreements
• Saudi NIH is working to try to create an standardized national CTA template

[1:06:09] Common misunderstandings

• English language support, quality health centers, sophisticated training
• Electronic Medical Record (EMR) systems exist in almost all hospitals

[1:07:50] Dr. Al Jeraisy’s resource recommendations

• ICA and GCP guidelines
• Turkish whitepaper – Turkey number one recruiting country in MENA region
• Collaboration with Seoul National University in South Korea

[1:14:05] Sponsor Message : This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Slope is trusted by industry leaders in complex early-phase clinical trials from top 50 pharma and CROs to emerging biotechs, and a global site network including NCI cancer centers and AMCs. Learn more at https://www.slopeclinical.com/