By: ABRS- Clinical Insights Team
Abstract
Global clinical development is undergoing a geographic shift. As sponsors seek more representative data, resilient trial execution, and sustainable research ecosystems, emerging regions are becoming increasingly important contributors to clinical research. Beyond access to larger and more diverse patient populations, these regions are strengthening regulatory frameworks, investing in research infrastructure, and aligning more closely with international standards of good clinical practice.
This article explores the key drivers behind the growing role of emerging regions in global clinical development, including the demand for diversity in evidence generation, the expansion of local research capacity, evolving regulatory alignment, and changing global trial distribution patterns. Understanding these factors is critical for sponsors and research partners aiming to design robust, ethical, and globally relevant clinical trials.
Introduction
The landscape of clinical research is becoming more global, complex, and interconnected. Traditional trial hubs in North America and Western Europe continue to play a central role, but they no longer operate in isolation. Increasing scientific, regulatory, and operational demands are pushing sponsors to rethink where and how clinical trials are conducted.
Emerging regions are gaining attention not as alternative locations, but as essential contributors to modern clinical development strategies. Growing patient populations, expanding investigator expertise, and strengthened regulatory oversight are positioning these regions as viable and, in many cases, necessary participants in global trials. At the same time, regulators and global health organizations are emphasizing the importance of inclusive and representative evidence to ensure that new therapies are safe and effective across diverse populations.
This shift is not without challenges. Conducting trials across varied healthcare systems, regulatory environments, and cultural contexts requires strong operational oversight, local expertise, and a commitment to quality and ethical standards. However, when approached strategically, the inclusion of emerging regions can enhance the robustness, relevance, and resilience of clinical development programs.
The following sections examine the key factors driving the increased participation of emerging regions in global clinical research and why their role is expected to continue expanding in the years ahead.
Emerging Regions and the Push for More Representative Evidence
One of the strongest drivers behind the growing inclusion of emerging regions in global clinical development is the increasing demand for more representative clinical evidence. Regulatory authorities have emphasized that clinical trial populations should better reflect the patients who will ultimately use approved therapies. When trials are conducted primarily in limited geographic areas, they may not fully capture variations in genetics, comorbidities, and treatment responses across diverse populations (U.S. Food and Drug Administration [FDA], 2020.
To address this challenge, regulators have encouraged sponsors to reassess traditional eligibility criteria and enrollment practices. FDA guidance highlights that broadening inclusion criteria, adapting trial designs, and reducing unnecessary participation barriers can improve diversity without compromising scientific rigor or participant safety (FDA, 2020)
From a global health perspective, the World Health Organization has reinforced that inclusive clinical research is both a scientific and ethical imperative. WHO guidance underscores that trials conducted across different health systems—when aligned with international standards—can enhance the applicability of results while maintaining participant protection, transparency, and data quality (World Health Organization [WHO], 2023. In this context, emerging regions offer a meaningful opportunity to support the generation of robust, globally relevant evidence.
Capacity Building and the Importance of Local Research Infrastructure
Beyond population size and diversity, the growing role of emerging regions in global clinical development is closely linked to sustained investments in local research capacity. Global health stakeholders have increasingly emphasized that effective clinical trials cannot be deployed ad hoc; they require established infrastructure, trained personnel, and regulatory readiness well before a study begins. A joint report supported by the World Bank and the Coalition for Epidemic Preparedness Innovations highlights that strengthening clinical research capacity in low- and middle-income countries is essential not only for routine drug development, but also for ensuring timely and credible trials during public health emergencies (International Vaccines Task Force, 2018).
The same report underscores that research ecosystems built solely in response to crises are often unsustainable. Instead, long-term investments in sites, laboratories, data systems, and operational expertise are needed to support consistent trial execution across therapeutic areas. When these foundations are in place, emerging regions are better positioned to participate in global development programs with the same expectations for quality, compliance, and data integrity as more established markets (International Vaccines Task Force, 2018).
Academic literature and global policy guidance consistently link clinical research capacity building with broader health system preparedness. Authoritative reports from the World Bank emphasize that countries with established research infrastructure—supported by trained personnel, governance frameworks, and sustainable funding—are better positioned to initiate and conduct clinical trials during public health emergencies, while maintaining ethical standards and data integrity (International Vaccines Task Force, 2018).
This perspective is reinforced by guidance from the World Health Organization, which underscores that resilient clinical trial ecosystems depend on long-term investments rather than reactive, crisis-driven efforts. According to the WHO, the ability to conduct high-quality trials across different contexts requires durable systems for ethical oversight, regulatory review, and operational coordination—elements that are developed over time through consistent capacity strengthening initiatives (World Health Organization, 2023).
Together, these findings support the view that emerging regions become reliable partners in global clinical development not by virtue of geography alone, but through deliberate and sustained investments in people, systems, and governance structures that align with international standards.
Regulatory Alignment and the Evolution of Good Clinical Practice
As clinical trials expand across regions with varying regulatory maturity, alignment with international standards has become a critical factor in determining where studies can be conducted effectively. Emerging regions are increasingly integrated into global development programs as regulatory authorities adopt harmonized frameworks that support both innovation and data integrity. Central to this evolution is the modernization of Good Clinical Practice, which has shifted from a prescriptive, process-heavy model toward a more flexible and risk-based approach (International Council for Harmonisation, 2023).
The updated ICH E6(R3) guidance emphasizes quality by design, proportionate oversight, and clear governance of trial activities across all participating regions. Rather than applying uniform operational controls regardless of context, the guideline encourages sponsors and research partners to tailor oversight strategies based on study complexity, critical data, and participant risk. This approach supports the inclusion of emerging regions by allowing operational models that are robust yet adaptable, while maintaining consistent expectations for participant safety and data reliability across global trials (International Council for Harmonisation, 2023).
In parallel, the World Health Organization has reinforced the importance of regulatory and ethical alignment as foundational elements of sustainable clinical trial ecosystems. WHO guidance highlights that effective trials require more than regulatory approval; they depend on coordinated systems for ethical review, regulatory oversight, and institutional accountability that function reliably across different health systems. Strengthening these systems enables countries to participate in multinational trials while ensuring transparency, participant protection, and public trust (World Health Organization, 2023).
Together, these regulatory developments support a more inclusive global research environment in which emerging regions can contribute meaningfully to clinical development. Alignment with modern GCP principles does not eliminate regional differences, but it provides a shared framework that enables sponsors, investigators, and regulators to collaborate effectively. As a result, regulatory convergence is increasingly viewed not as a barrier, but as an enabler of high-quality, globally relevant clinical research.
Shifting Trial Geography and Global Distribution Trends
The global distribution of clinical trials is evolving beyond traditional hubs, with some regions gaining prominence while others see changes in their relative share of activity. According to recent analysis of clinical trial ecosystems, Europe’s share of commercial clinical studies — those sponsored by pharmaceutical companies — has declined over the past decade, illustrating how geographic participation can shift even as overall trial activity grows. Between 2013 and 2023, Europe’s share of commercial trials in the European Economic Area dropped significantly, reflecting broader shifts in where sponsors choose to conduct research and enroll patients (European Federation of Pharmaceutical Industries and Associations & IQVIA report, 2024). EFPIA
These changes are further evident in global R&D trend data, which show that overall clinical trial activity has increased substantially in recent years, driven by growing research complexity and innovation demands. As sponsors consider where to place studies, factors such as regulatory environment, patient availability, and operational readiness influence geographic choices, contributing to more distributed networks of trial sites across Asia, North America, and other emerging regions. Data from the IQVIA Institute’s 2024 R&D trends report indicate that clinical research participation is not static but reflects strategic decisions by sponsors responding to shifting patient needs and development priorities. IQVIA
In addition, industry analyses highlight that while global clinical trial volume has grown, the relative contribution of different regions can vary based on broader economic and regulatory conditions. For example, Europe’s declining share in commercial trials has coincided with growth in other regions, suggesting that sponsors increasingly view Asia and other markets as viable alternatives for recruitment and operational execution, where infrastructure and regulatory reforms support efficient study conduct. EFPIA
Taken together, these trends indicate that clinical trial geography is becoming more dynamic. Emerging regions are not merely peripheral participants — they are increasingly integrated into global development strategies as sponsors seek diversified networks that balance scientific representativeness, regulatory alignment, and operational efficiency. This evolving distribution reflects ongoing changes in how and where evidence is generated in clinical research.
Conclusion
The growing role of emerging regions in global clinical development reflects a broader transformation in how clinical research is designed and executed. As the industry seeks more representative evidence, resilient operations, and sustainable trial ecosystems, geographic diversification has become a strategic necessity rather than an operational alternative.
Across emerging regions, progress in research capacity, regulatory alignment, and infrastructure development has enabled more meaningful participation in multinational trials. When supported by long-term investments in people, systems, and governance, these regions can contribute high-quality data while meeting international expectations for ethics, compliance, and oversight. This evolution challenges outdated perceptions that equate trial quality solely with traditional research hubs.
At the same time, the shifting geography of clinical trials underscores the importance of thoughtful planning and strong operational oversight. Expanding into new regions requires more than access to patients; it demands local expertise, regulatory fluency, and collaborative execution models that integrate seamlessly into global development strategies.
Looking ahead, the continued integration of emerging regions will play a critical role in advancing inclusive, efficient, and globally relevant clinical research. Sponsors and research partners that approach this evolution strategically—grounded in quality, transparency, and long-term collaboration—will be better positioned to navigate the complexities of modern clinical development and generate evidence that truly reflects global patient populations.
References
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https://www.ich.org/page/efficacy-guidelines
International Vaccines Task Force. (2018). Money & microbes: Strengthening clinical research capacity to prevent epidemics. World Bank.
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IQVIA Institute for Human Data Science. (2024). Global trends in R&D 2024: Activity, productivity, and enablers.
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https://www.who.int/publications/i/item/9789240097711
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