Abstract
Background and Rationale
Thailand possesses strong structural potential to develop into a regional hub for clinical
research. This potential is underpinned by a large and diverse patient population,
internationally accredited healthcare infrastructure, a highly skilled medical workforce, and a
supportive and evolving policy environment.
However, findings from fieldwork and qualitative data collection through in-depth stakeholder
interviews indicate that these strengths have not yet been fully leveraged. This is primarily
due to systemic constraints, particularly fragmentation across key components of the
ecosystem and the absence of a central coordinating mechanism to effectively integrate
these elements.
This study aims to (1) identify key systemic barriers, (2) synthesize policy recommendations
from the perspectives of relevant stakeholders, and (3) propose strategic directions to
strengthen Thailand’s clinical research ecosystem.
The study adopts a Design Thinking approach as its core methodological framework to
generate stakeholder-centric insights. It draws on qualitative data from in-depth interviews
with 57 stakeholders, two multi-sectoral workshops, and a comprehensive literature review,
with the objective of updating and extending prior analyses to reflect the current context.
Progress and Persistent Systemic Gaps
Over the past eight years, Thailand’s clinical research ecosystem has made notable progress
across several dimensions. These include an increase in internationally accredited ethics
committees, the implementation of full-scale e-submission systems by regulatory authorities,
the establishment of national research networks, and the development of supporting data
platforms.
Despite these advancements, key systemic gaps identified in earlier studies persist. These
include prolonged approval timelines compared to peer countries, the absence of a
centralized authority with coordinating power, and the lack of institutional prioritization of
clinical research within healthcare providers.
A key finding of this study is that the primary constraint is not a lack of resources or capacity.
Rather, it lies in the design of the system itself and the absence of effective coordination
mechanisms that enable different components to function cohesively.
Five Systematic Changes
1. Data Fragmentation
Research-related data remain dispersed across multiple unconnected systems, limiting
efficient access for study planning. There is no national database covering investigators, site
capabilities, or trial participants. In addition, public awareness and perception of clinical trials
remain limited, affecting participant recruitment.
2. Duplication in Ethics Review Processes
Ethics review processes are often duplicated across central and institutional levels,
increasing time and cost without significantly enhancing participant protection. There is also
a lack of structured workforce development and clear career pathways for ethics committee
members.
3. Regulatory Constraints
Regulatory processes are not sufficiently risk-based and remain constrained by limited human
resources, resulting in unpredictable approval timelines. In addition, regulatory frameworks
for advanced therapeutic medical products (ATMPs) remain underdeveloped.
4. Public–Private Coordination Gaps
There is no effective mechanism to align private sector demand with research capabilities.
Public financial regulations are not well-suited to the nature of clinical research, and
investigator-initiated trials (IITs) place disproportionate administrative burdens on individual
researchers.
5. Limited CRC Capacity
Clinical Research Centers (CRCs) are not formally recognized as a core mission within
healthcare institutions. This results in insufficient structural support, including staffing,
funding, and career pathways. There is also no national accreditation system or risk-sharing
mechanism for research.
Strategic Proposals: Three Pillars
Based on qualitative and system-level analysis, the study proposes 13 policy measures
structured under three strategic pillars, with a central coordinating body (NCRCB) serving as
the primary implementation mechanism.
Pillar 1: People and Institutions
Strengthening human capital and institutional capacity through a national CRC master plan,
a standardized accreditation system, research support mechanisms, and instruments to
attract international clinical trials.
Pillar 2: Process Optimization
Addressing system bottlenecks through integrated review processes, single submission
systems, and the adoption of risk-based regulatory approaches.
Pillar 3: Data and Infrastructure
Establishing a national data infrastructure to support decision-making, data integration, and
public access, including centralized research data platforms and volunteer registries.
Implementation Roadmap
The proposed implementation is structured into three phases:
● Phase 1 (Year 1): Foundation
Establishment of the central coordinating body (NCRCB) and development of
necessary policy and regulatory frameworks.
● Phase 2 (Years 2–3): Strengthening
Reform of regulatory and ethics processes, strengthening of CRC capacity, and
development of key support mechanisms.
● Phase 3 (Year 4 onwards): Sustainability and Competitiveness
Development of a fully integrated and competitive ecosystem, including national data
systems, CRO development, and international collaboration.
Conclusion
Thailand possesses substantial resources and foundational strengths. However, it lacks the
institutional mechanisms required to effectively integrate and operationalize these
components.
The establishment of a central coordinating body with both authority and stakeholder trust is
therefore a critical prerequisite for systemic transformation.
Investment in the clinical research ecosystem should not be viewed solely as a healthcare
expenditure, but rather as a strategic investment in national competitiveness, innovation
capacity, and long-term population health outcomes.
