Research services
Clinical Trials
Enabling patients in Saudi Arabia to participate safely in high-quality clinical trials.
Overview
Clinical Trials are an essential part of research. They are designed to show whether a new research idea can be used safely and effectively in human patients.
The interventions studied in clinical trials can be in the form of tests, therapies, or devices. Clinical trials are approved by an independent review board prior to proceeding, to ensure ethics, safety, and quality. Clinical trials are conducted in phases. It is only after all phases are complete and the intervention proven to provide benefit that it is made available to the public.
Leading Clinical Trials in the Kingdom
The establishment of our Clinical Trials service in 2020 is a testament to the thriving culture of scientific study and innovation at our hospital and research centre. At present, almost half of the total active clinical trials in the Kingdom are currently conducted at KFSHRC.
Our service coordinates and oversees all the clinical trials run by the hospital’s clinicians and researchers. Serving as a central hub, we provide end-to-end trial management, advising on feasibility, trial operations and various research needs from activation to completion. We help researchers engage with patients, and collaborate with investigators, sponsors, and global partners.
Whatever the challenges, we work to ensure that trials are run to the highest standards, to deliver the best outcomes, and ensure that patients have safe and early access to cutting-edge treatments.
Types and Phases of Clinical Trials
Clinical trials may study a variety of interventions including screening tests, diagnostic tests, drugs or other therapies, procedures, preventative measures, or medical devices. They are conducted in phases which serve different research functions, with more patients enrolled in each subsequent phase.
Phase I - a small group of –10-50 patients are recruited, to test the intervention for safety and to identify side-effects.
Phase II - a larger group of –20-100 patients are now taking part, and the effectiveness of the intervention is tested, along with further evaluation of its safety.
Phase III - an even larger group of 100 – 3000+ patients receive the intervention, and the trial continues to monitor effectiveness and side effects. Researchers also compare their findings with standard or equivalent treatments.
Phase IV - by this phase, the intervention has been approved by the SFDA, and is available to the public. Researchers monitor its long-term safety and efficacy, ensuring that it continues to bring benefit to patients.
Beta Version