ADOPTION OF PRO/COA IN CLINICAL TRIALS IN CHINA (2020-2025...
Author(s)
Zhen Dong1, Bo jing Cai, BS, MS, MSc2, Wan Tzu Hsia,, MSc3, Shuo Yang, PhD2, Yang Xie, MPH, PhD2.
1IQVIA Asia, Singapore, Singapore, 2IQVIA, Shanghai, China, 3IQVIA Taiwan, Taiwan, Taiwan.
1IQVIA Asia, Singapore, Singapore, 2IQVIA, Shanghai, China, 3IQVIA Taiwan, Taiwan, Taiwan.
OBJECTIVES: Patient-focused drug development (PFDD) is increasingly emphasized by regulatory agencies across the world. In China, a series of guidance from the National Medical Products Administration (NMPA) since 2021 reflects a similar trend. With patient experience and outcomes gaining importance in regulatory decisions, it’s also increasingly emphasized in HTA and reimbursement decisions. This study examines inclusion of clinical outcome assessment (COA)/patient reported outcome (PRO) endpoint in clinical trials in China and analyse the trends by therapeutic area and trial phase.
METHODS: ClinicalTrials.gov was systematically searched for interventional trials initiated between 2020 and 2025 with at least one site in China. Trials explicitly listing a COA/PRO endpoint were identified via keyword search of the Outcome Measures (e.g., questionnaire, patient diary, PRO, COA, HRQoL, VAS, and instruments such as EQ‑5D, SF‑36, PGIC, BPI, FACIT). Identified trials were aggregated by initiation year, therapeutic area, and trial phase (I-III).
RESULTS: Among 7,226 trials in China 2020-2025, 1,024 (14%) included at least one COA/PRO endpoint as primary or secondary endpoints. The annual number of such trials rose from ~160 in 2020 to ~210 in 2024, before a slight decline to ~190 in 2025. By therapeutic area, PRO usage was highest in Immunology, with frequent inclusion as both primary and secondary outcomes. For primary outcomes, PRO endpoints were most common in immunology (~11.6%) and CNS (~9.2%). A similar pattern was seen in secondary outcomes, with the highest usage in immunology (~42.5%), followed by oncology (~28.9%), CNS (~26.5%), and cardiovascular/metabolic/endocrinology (~12.8%). COA/PRO endpoints were observed across all trial phases (~25% Phase I, 34% Phase II, 41% Phase III), indicating use throughout the clinical development lifecycle.
CONCLUSIONS: These findings highlight an ongoing transition toward systematic integration of patient experiences in clinical trials in China. Early COA/PRO planning is increasingly important for generating patient-relevant evidence and ensuring regulatory alignment.
METHODS: ClinicalTrials.gov was systematically searched for interventional trials initiated between 2020 and 2025 with at least one site in China. Trials explicitly listing a COA/PRO endpoint were identified via keyword search of the Outcome Measures (e.g., questionnaire, patient diary, PRO, COA, HRQoL, VAS, and instruments such as EQ‑5D, SF‑36, PGIC, BPI, FACIT). Identified trials were aggregated by initiation year, therapeutic area, and trial phase (I-III).
RESULTS: Among 7,226 trials in China 2020-2025, 1,024 (14%) included at least one COA/PRO endpoint as primary or secondary endpoints. The annual number of such trials rose from ~160 in 2020 to ~210 in 2024, before a slight decline to ~190 in 2025. By therapeutic area, PRO usage was highest in Immunology, with frequent inclusion as both primary and secondary outcomes. For primary outcomes, PRO endpoints were most common in immunology (~11.6%) and CNS (~9.2%). A similar pattern was seen in secondary outcomes, with the highest usage in immunology (~42.5%), followed by oncology (~28.9%), CNS (~26.5%), and cardiovascular/metabolic/endocrinology (~12.8%). COA/PRO endpoints were observed across all trial phases (~25% Phase I, 34% Phase II, 41% Phase III), indicating use throughout the clinical development lifecycle.
CONCLUSIONS: These findings highlight an ongoing transition toward systematic integration of patient experiences in clinical trials in China. Early COA/PRO planning is increasingly important for generating patient-relevant evidence and ensuring regulatory alignment.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
PCR16
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Neurological Disorders, SDC: Oncology, SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)