As a part of the sweeping transformation Saudi Arabia is achieving thanks to its Vision 2030, the Kingdom is also advancing its research ambitions. With the restructuring of its regulatory framework along with its well-established network of research institutes and bolstered by the integration of electronic health records, Saudi has made major strides towards its grand ambitions of becoming a regional – and eventually even a global – clinical trials hub, as recent PharmaBoardroom interviewees confirm.
Strong Existing Research Network
Saudi Arabia may not yet be known as an international hub for clinical trials, but the Kingdom, home to an abundance of strong research institutes, is making a steady push to bolster its research ecosystem and attract clinical research. “Saudi Arabia presents an attractive hub for research, not only due to its focus on fostering research and clinical development but also because of its esteemed institutions and capabilities in both medical and research fields,” says Eid Mansour , GM at Gilead Sciences Saudi Arabia.
As a result of these positive attributes, Gilead is looking to bring clinical trials to the country. “Saudi Arabia has the capabilities to host clinical trials across various therapeutic areas. Our aim is to bring clinical trials to Saudi Arabia, in alignment with our commitment to advancing medical research in the region.”
One of the country’s most well-establish research institutions is the King Saud University Medical City (KSUMC). Created in 1970, it is the oldest and largest academic medical centre in Saudi Arabia and has established itself as “one of the leading centres for clinical trials in the Riyadh region with our clinical trial unit being among the first in the area and earning a strong reputation,” asserts CEO Ahmad Hersi.
The KSUMC, with about 40 to 60 percent industry-sponsored trials and 30 to 50 percent investigator-initiated, aims to position itself at the vanguard of clinical research, trailblazing for the entire region. “We have led the way in conducting the first-in-man device trials in the entire MENA region, demonstrating our eagerness to be at the forefront of clinical research.” The institution conducts phase two, three, and four medication trials and has also ventured into phase one device trials.
Regulatory Overhaul
Saudi also boasts its own home-grown contract research organizations that have benefitted from the development of the healthcare sector and the restructuring of a regulatory framework to support clinical trials. For Mohamed Mostafa, CEO of PDC-CRO, these transformations have created a robust system for clinical research in the country. “The regulatory framework has evolved remarkably, ensuring a robust system for clinical trials and research ethics.”
Saudi has also put in place the Saudi National Institute for Health (SNIH), a body that oversees and supports translational research and clinical trials, another move Mostafa praises. “The establishment of the Saudi NIH has further solidified the country’s commitment to advancing clinical trials and the biotech Incubator plan.”
The SNIH is unique in that it not only provides funding but also facilitates communication among stakeholders, including sponsors, CROs, hospitals, and regulators, something that has simplified a number of operations, Mostafa notes. “This comprehensive approach has streamlined processes such as site activation and documentation, reducing hurdles for conducting clinical trials in the country.”
Dedicated Clinical Trial Units and SMOs
The shift in the clinical trials landscape in Saudi Arabia has included the creation of dedicated clinical trial units within hospitals and the introduction of site management organizations (SMOs) to streamline trial operations, says Mostafa. “These developments have alleviated many of the administrative burdens traditionally associated with conducting clinical trials.”
In the PDC-CRO chief executive’s view “the emergence of SMOs has been particularly instrumental in enhancing logistical support for clinical trials. These organizations handle various aspects of trial management, including patient recruitment, logistics coordination, and budget management, allowing investigators to focus solely on medical aspects of patient care. This delegation of logistical responsibilities has significantly reduced the time and effort required from investigators, making clinical trial participation more feasible and appealing.”
Another benefit of these developments for Mostafa is the bridging of the communication gap between pharmaceutical companies and investigators. “With many biotech firms lacking a physical presence in Saudi Arabia, SMOs serve as intermediaries, facilitating collaboration and trial implementation between sponsors and investigators. This enhanced connectivity has increased the accessibility of clinical trials to investigators, further incentivizing participation.”
Electronic health records and patient recruitment
Recruiting patients is another area that has undergone positive evolution. “Patient recruitment for clinical trials in Saudi Arabia has seen significant improvements driven by advancements in technology and the integration of electronic health records (EHRs) across healthcare institutions,” says Mostafa. “The integration of EHRs allows for more efficient patient identification based on eligibility criteria, enabling a larger pool of potential participants.”
Further Capitalizing on Saudi’s Potential
While major strides have been made in strengthening the kingdom’s position as a clinical trials centre, “to fully capitalize on Saudi Arabia’s potential as a hub for clinical trials, there needs to be alignment between scientific, strategic, and investment objectives,” Mostafa argues, claiming that many companies have made major investments in the region without an accompanying operational strategy. “Companies must develop comprehensive strategies that consider the unique opportunities and challenges present in the region. By aligning these elements and fostering collaboration between stakeholders, the vision of Saudi Arabia as a leading destination for clinical research can be realized.”
The competition is stiff, however, as Biogen’s Head of GCC, Diederik Kok points out. While the company is already conducting clinical trials in Saudi “with one of the largest patient cohorts globally,” Kok notes that “to attract more trials, it is crucial to understand and meet the rigorous requirements set by companies and regulatory bodies. Given the competition with established trial locations like the UK, Spain, and Germany, ensuring quality and efficiency in trial conduct is paramount. By facilitating collaborations and fostering a supportive regulatory environment, Saudi Arabia can position itself as an attractive destination for clinical trials, contributing significantly to its aspirations of becoming a leading innovation hub in the coming decades.”
