Establishing a clinical trial center in a Traditional Medicine Hospital: a strategic framework for standardizing operations and ensuring good clinical practice compliance

Abstract

Establishing a clinical trial center within a traditional medicine hospital is an increasingly important requirement for transitioning from fragmented research activities to a structured, well-governed clinical research system that complies with Good Clinical Practice (GCP). This review analyzes the core components required to standardize a clinical trial center, including governance, human resources, infrastructure, standardized procedures, participant safety, investigational product management, data integrity, quality management, and regulatory compliance. The analysis is informed by major international guidance and relevant literature, including ICH E6(R3), the 2024 Declaration of Helsinki, CIOMS/WHO guidance, and the WHO Traditional Medicine Strategy. A clinical trial center should not be defined primarily by its physical size or equipment, but by an integrated system of governance, standardized processes, clearly assigned responsibilities, and quality control. Standard Operating Procedures (SOPs) constitute a key operational instrument within the quality assurance system. For herbal medicines and traditional medicines, specific challenges, including batch-to-batch variability in active constituents, the feasibility of placebo development, herb–drug interactions, and pharmacovigilance require careful assessment and should be incorporated into both trial design and the operational framework of the clinical trial center from the outset. This article proposes a roadmap for establishing clinical trial centers in traditional medicine hospitals, with an emphasis on developing an integrated clinical research system, implementing GCP-compliant standards, and creating a foundation for participation in multicenter studies and integration into national and international clinical research networks.