What does clinical trial diversity mean for emerging regions?
The case of Georgia
Georgia, a country with over two decades of experience in conducting clinical trials, provides a unique perspective on inclusive clinical research. Despite being considered a developing country, over this period, Georgia developed a solid network of investigators, project managers, CRAs and study coordinators. In addition, there are many small, home-grown CROs as well as affiliates of larger CROs operating in the region. This success is largely due to the country’s transparent and favourable regulations. For instance, the Ministry of Health processes clinical trial approvals within just 20 calendar days, which has served as a significant market entry incentive for many organizations.
Understanding diversity in Georgia begins by assessing economic factors. Dr George Ramishvili, Chief Executive Officer at New Hospitals Ltd in Georgia, explains: “Economics does play a role because, in a country with a GDP per capita of $5,000, we try to provide healthcare at the same level as a country with a GDP per capita of $50,000. There is a difference, and this difference is also evident when we talk about healthcare expenditures. In Europe, state healthcare spending could range from 5% to 12%, or even more, while in developing countries, it could be 3% or even less.”
Access to healthcare is also a significant consideration, particularly in rural areas. In smaller countries such as Georgia, the population may gain from better geographical access to healthcare services, whereas larger countries may face challenges with accessibility due to the vast distances between rural areas and urban centres. Thus, in Georgia, it is comparatively easier for patients in remote areas to receive care than in larger countries.
A further factor contributing to diversity in clinical trials is the variation in diet and nutrition. While Georgia is commonly classified as a European country, its dietary habits differ significantly from those of other European nations. This encompasses not only food but also the intake of vitamins and nutrients, which can influence the baseline health of patients in the region. The nutritional habits of Georgian patients may differ from those in other countries, potentially affecting their response to new study drugs. Such differences may be considered when designing clinical trials.
In terms of lifestyle, the country has experienced a shift toward health consciousness in recent years. A growing number of individuals are engaging in physical activities and visiting fitness facilities, which contributes to improved overall health and may enhance patient adherence to clinical trial protocols. This change in healthier habits represents an important development for clinical trials in Georgia and arises as a potential consideration in other emerging regions.
Additionally, the country’s healthcare system faces challenges in the reimbursement of modern biotech medicines, which can sometimes result in patients being undertreated. However, this situation also increases the willingness of patients to participate in clinical trials, as they gain access to treatments that may otherwise be unavailable. This could imply that the baseline health of these patients may be different in various countries, which could influence the outcomes of clinical trials. Data from patients who are not receiving the most current treatments may differ greatly from those receiving care in accordance with the latest guidelines.
During the COVID-19 pandemic, the use of remote healthcare tools saw a significant increase in Georgia. However, from the perspective of Dr Ramishvili, the physical interaction between doctor and patient remains irreplaceable; while also considering the shorter distances and easier access to healthcare in the country, compared to larger regions. It is recommended that patients be brought to centralised medical centres for procedures to ensure services are delivered according to the highest standards and patient safety regulations. Even though telemedicine may be suitable for follow-up visits, initial consultations should involve an in-person visit to facilitate a comprehensive physical assessment of the patient, ensuring appropriate care.
While Georgia may not exhibit the same level of diversity as larger countries, it still possesses a significant degree of diversity within its population. Various nationalities and patient groups reside in Georgia, each bringing unique qualities. This diversity should be accounted for when designing clinical trials, as it provides valuable insights into how different patient populations respond to treatments.
