In this Q&A, we interview Dr. Tamara Sunbul, a digital health clinical trial leader. Dr. Sunbul discusses the regulatory landscape, patient engagement strategies, and the future of digital health in Saudi Arabia. Her insights offer a comprehensive view of the challenges and opportunities in this rapidly evolving field.

Moe Alsumidaie: How do you improve patient enrollment and retention in Saudi clinical trials?

Dr. Tamara Sunbul: To ensure that trials are not standalone but are part of the regular care patients receive, we embed clinical trials within the existing framework of standard medical procedures to provide a unified patient experience, ultimately bolstering both engagement and retention. For instance, when conducting a diabetic eye exam using machine learning, we perform the regular camera exam alongside the digital trial. This dual approach is necessary because, until we receive SFDA approval, we cannot rely solely on the digital method.. This strategy respects cultural preferences for comprehensive care and ensures patients feel secure and supported throughout the trial process. By embedding trials within

Dr. Tamara Sunbul, Digital Health Clinical Trial Leader

routine care, we address cultural sensitivities and enhance patient trust, which are crucial for successful enrollment and retention. This method also allows us to gather more comprehensive data, improving our research outcomes’ overall quality and reliability.

Moe Alsumidaie: What challenges exist in attracting Big Pharma funding for trials in Saudi Arabia?

Dr. Tamara Sunbul: There are abundant funding opportunities across multiple sectors in Saudi Arabia, and we have strong buy-in from developers. This creates a sustainable ecosystem that allows us to focus on collaboration rather than financial constraints, fostering a supportive environment for innovation. This model encourages mutual assistance and shared goals, which can appeal more to developers than traditional funding models. By creating a collaborative ecosystem, we can attract more interest and investment from Big Pharma, as they see the value in partnering with a system that supports innovation and mutual growth. This approach benefits the developers and enhances the quality and scope of clinical trials conducted in Saudi Arabia.

Moe Alsumidaie: How do international collaborations enhance Saudi clinical trials?

Dr. Tamara Sunbul: While we do engage in some international collaborations, the regulatory environment in Saudi Arabia requires that all trials be re-registered locally. Even if a trial has FDA or EU approval, it must still be reviwed here to ensure it meets local standards and addresses population-specific data biases. This rigorous process ensures international partnerships enhance our research capabilities by providing robust, locally relevant data. By adhering to these stringent regulations, we can ensure that the data collected applies to our population, thereby improving the accuracy and reliability of our research outcomes. This approach strengthens our research capabilities and positions Saudi Arabia as a key player in the global clinical trial landscape.

Moe Alsumidaie: How does Saudi Arabia’s tech infrastructure support digital health trials?

Dr. Tamara Sunbul: Saudi Arabia’s technology infrastructure is well-equipped to support digital health initiatives, thanks partly to regulatory sandboxes. These sandboxes act as incubators, ensuring all digital health solutions are thoroughly tested and compliant with cybersecurity standards before implementation. This proactive approach facilitates the smooth rollout of digital health projects and builds trust among stakeholders by ensuring that all solutions are safe and effective. By leveraging these regulatory sandboxes, we can streamline the development and implementation of digital health solutions, making it easier for developers to bring their innovations to market. This infrastructure supports the growth of digital health in Saudi Arabia and enhances our ability to conduct high-quality, reliable clinical trials.

Moe Alsumidaie: How is data privacy addressed in Saudi digital health trials?

Dr. Tamara Sunbul: Data privacy is a top priority in Saudi Arabia, with robust measures in place similar to GDPR. The Personal Data Protection Law (PDPL) and AI governance policies provide clear data handling and protection guidelines. These policies ensure that all digital health initiatives comply with local and international standards, offering a secure framework for data management. This clarity in regulations helps streamline processes and encourages innovation by providing a clear path for compliance. By adhering to these stringent data protection measures, we can ensure the privacy and security of patient data, which is crucial for building trust and confidence in digital health solutions. This approach protects patient privacy and enhances the quality and reliability of our clinical trials.

Moe Alsumidaie: Are there disparities in access to digital health in Saudi Arabia?

Dr. Tamara Sunbul: Inclusion is a key focus of our AI governance policies, emphasizing access for all demographics, including those in remote areas and senior citizens. We address potential disparities by validating data locally, ensuring that solutions are tailored to the specific needs of our population. This approach recognizes that what works in other regions may not directly apply here, necessitating localized trials even for internationally approved solutions. By focusing on inclusion and local validation, we can ensure that digital health solutions are accessible to all, regardless of location or demographic.

Moe Alsumidaie: How do you see digital health and trials evolving in Saudi Arabia?

Dr. Tamara Sunbul: The future of digital health and decentralized trials in Saudi Arabia looks promising, thanks to stringent regulations that ensure quality and safety. Clinical trials are heavily regulated, requiring centers to be CBAHI accredited, which guarantees that all necessary infrastructure and policies are in place. This regulatory framework ensures high standards and facilitates the expansion of trials, potentially increasing diversity and accessibility in the future. By adhering to these stringent regulations, we can ensure that our clinical trials are of the highest quality, enhancing our ability to attract international collaborations and investment.

Moe Alsumidaie: Are trials only in large hospitals, or are they expanding to private sectors?

Dr. Tamara Sunbul: Clinical trials in Saudi Arabia are not limited to large hospital systems; they can be conducted in any institution that meets the necessary accreditation requirements. This includes private hospitals, provided they obtain CBAHI certification. This flexibility allows for a broader range of trial sites, encouraging wider participation and fostering a more inclusive research environment. By expanding the scope of clinical trials to include private hospitals, we can increase the diversity and accessibility of our research, which will enhance the overall quality and reliability of our clinical trials. This approach benefits the research community and improves the overall quality of healthcare in Saudi Arabia.

Moe Alsumidaie: Is there anything else you’d like to add about Saudi clinical trials?

Dr. Tamara Sunbul: I’m excited about the developments in digital health and clinical trials in Saudi Arabia. The clear policies and regulations we have in place are crucial for progress, providing a solid foundation for innovation and ensuring that all stakeholders understand the rules of engagement. This clarity will likely accelerate advancements in digital clinical trials, positioning Saudi Arabia as a leader in this field. By adhering to these stringent regulations, we can ensure that our clinical trials are of the highest quality, enhancing our ability to attract international collaborations and investment.

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Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.