Clinical trials (CT) are research that studies new tests and treatments and evaluates their effects on human health outcomes. This article will explain the SFDA requirements and regulations needed to conduct a clinical trial in Saudi Arabia.
Clinical Trials Phases
Most of the clinical trials conducted in Saudi are related to phases III and IV. There are 4 phases of clinical trials:
- Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
- Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
- Phase III studies are conducted on larger populations in different regions and countries and are often the step right before a new treatment is approved.
- Phase IV studies take place after country approval, and there is a need for further testing in a broad population over a longer timeframe.
Clinical Trial Application CTAp
SFDA requires sponsors without a legal entity in Saudi to apply through an SFDA licensed Saudi CRO. On the other hand, sponsors with a Saudi legal entity can apply directly or through a CRO. The SFDA also specified who should apply according to the CT sponsorship. If the Clinical trial is sponsored by:
- The Governmental Sectors: The applicant will be the research centre, hospital, CRO, or principal investigator that the sponsor authorises.
- Private Sector: The sponsor institution or the CRO.
- Unsponsored clinical trial: The applicant will be the principal investigator or the CRO.
To Initiate the Clinical Trial Application (CTAp) in Saudi Arabia, sponsor or licensed CROs should create an account on the Saudi Clinical Trials Registry (SCTR) to comply with SFDA Regulations and Requirements for Conducting Clinical Trials.
Clinical Trials Fees
The applicant must pay the SFDA fees for valuating the clinical trial file. Trials excluded from paying the fees are:
- Clinical trials that are sponsored by Governmental Sectors.
- Unsponsored CT submitted by researchers.
- Phase four IV studies.
The CRO organisational structure should include departments or individuals that ensure the conduction of clinical trials of high quality, according to applicable regulations, and that trial data are credible and accurate. The organisational structure should reflect on services provided to perform one or more clinical trial-related activities; accordingly, the CRO organisational structure should be updated every five years or per institutional policy.
Monitoring of the Clinical Trials
A licensed CRO delegated to perform monitoring responsibilities needs to follow SFDA regulations and provide a written agreement to delegate clinical trial responsibilities from the sponsor to the CRO. The sponsor of a clinical trial will retain the responsibility for oversight of the activities done by the CRO.
A monitoring plan is an essential part of each clinical trial, which contains a description of the monitoring methods, responsibilities, and requirements for the CT. It should include a brief description of the study, its objectives, and the critical data and study procedures.
On-site monitoring is an in-person assessment carried out by the sponsor or CRO personnel at the clinical trial’s site. Factors affecting the extent of the monitoring plan and may necessitate on-site monitoring are:
- Complex Study Design (e.g. adaptive designs, stratified designs, or complex dose titrations).
- Study Endpoints (interpretative or subjective).
- Study Population (seriously ill or vulnerable).
- Experience of the Principal Investigator (PI).
- The Electronic data capture (EDC).
- Stage of the study (initiation and during the early stages of a trial).
- Quantity of data
Trial Master File (TMF)
The sponsor has the ultimate responsibility for the trial activities and oversight. Therefore, the sponsor should allow access to the TMF for the licensed CRO and specify the parts to be accessed by the licensed CRO to fulfil their responsibilities. The sponsor or the CRO should implement risk-based quality checks (QC) or review processes to ensure the TMF is up-to-date and includes all essential documents.
Clinical Research Associate Employees (CRA)
The sponsor and\or licensed CRO should select qualified monitors by education, training and experience. The SFDA recommended that CRA employees should be:
- A citizen or permanent legal resident in Saudi Arabia; the permanent resident should be authorised to work in Saudi Arabia.
- The sponsor or licensed CRO should submit documents to prove CRA education, training and experience qualifications.
Clinical Trials Agreement
The sponsors or CRO should submit the clinical trial agreement to the SFDA in bilingual (Arabic and English). They should be reviewed by the legal department or licensed attorney.
Documents & Data retention
The essential document(s) and data generated from conducting the clinical trial in Saudi Arabia should be kept for at least 15 years after completion or discontinuation of the trial or at least two years after registering the investigational medicinal product (IMP) at SFDA according to the clinical trial objectives.