Adoption and Challenges of Electronic Clinical Outcome Assessments and Patient-Reported Outcomes in China: Insights From a Survey of Healthcare Professionals and Industry Stakeholders
Author(s)
Hong Fang, Ms1, Zheng Yin, PhD2, Yuan Wang, PhD2, Jingxiao Zhu, Ms1, Quanyu Su, Ms3, Binxian Sun, Ms4, Feng Lin, Mr5, Xiaoying Yang, Ms6, Liyang Song, Ms7, Jing Wen, Ms5, Jinghua Zhao, PhD8, Bo jing Cai, Ms2, Jingyu Tong, Ms2, Ning Li, MD1.
1Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China, 2IQVIA Solutions Enterprise Management Consulting (Shanghai) Co., Ltd., Shanghai, China, 3EClinCloud (Ningbo) Technology Co., Ltd., Zhejiang, China, 4CMAC DCT group, Shanghai, China, 5Shanghai Xincere Med-Tech Inc., Shanghai, China, 6Jiangsu Simcere Pharmaceutical Co., Ltd., Jiangsu, China, 7Qurgen Ltd., Jiangsu, China, 8Fosun Kite Biotechnology Co., Ltd., Shanghai, China.
1Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China, 2IQVIA Solutions Enterprise Management Consulting (Shanghai) Co., Ltd., Shanghai, China, 3EClinCloud (Ningbo) Technology Co., Ltd., Zhejiang, China, 4CMAC DCT group, Shanghai, China, 5Shanghai Xincere Med-Tech Inc., Shanghai, China, 6Jiangsu Simcere Pharmaceutical Co., Ltd., Jiangsu, China, 7Qurgen Ltd., Jiangsu, China, 8Fosun Kite Biotechnology Co., Ltd., Shanghai, China.
OBJECTIVES: The role and advantages of patient experience data including clinical outcome assessments (COA) data in clinical trials and real-world studies have been increasingly recognized. As data collection tools transition from paper-based to electronic implementation, the concept of "patient-centered" has been reinforced. This study aims to gain deeper insights into the current application, user experience, challenges, and potential solutions for eCOA, especially electronic patient-reported outcome (PRO) in China.
METHODS: A cross-sectional electronic survey was conducted targeting professionals from hospitals, pharmaceutical companies, contract research organizations, site management organizations and technology companies. Snowball sampling was employed to distribute an on-line questionnaire, leveraging both accessible networks and referrals to reach a broader and relevant pool of stakeholders.
RESULTS: Of the 1,146 valid responses across the country, 94.9% (1,088/1,146) recognized the value of PROs in evaluating treatment efficacy, identifying unmet patient needs (69.6%), guiding physicians in disease management (70.0%), providing timely treatment feedback (79.5%), and enhancing doctor-patient communication (77.5%). Among 745 participating professionals with COA/PRO experience, challenges including insufficient localization of PRO measures (60.1%), accuracy of PRO during remote follow-ups (54.8%), and clinicians’ limited understanding on applying PRO results (47.7%) were identified. Most professionals with experiences in eCOA/ePRO were satisfied (71.1%) with current solutions, with concerns in using electronic devices (462, 80.6%), motivating patients to complete forms (373, 65.1%), technical issues (336, 58.6%), data integrity (293, 51.1%), insufficient patient training (252, 44.0%), and data protection through electronic means (153, 26.7%). Three-fourths of participating professionals planned use of eCOA/ePRO in the future.
CONCLUSIONS: The findings highlight the critical need for enhanced localization, robust technical support, ensured data integrity and safety, and seamless integration with existing systems to optimize the efficacy of eCOA/ePRO in China. The comprehensive overview of the current landscape and future potential of eCOA/ePRO implementation can facilitate broader adoption and improved outcomes in clinical and real-world settings.
METHODS: A cross-sectional electronic survey was conducted targeting professionals from hospitals, pharmaceutical companies, contract research organizations, site management organizations and technology companies. Snowball sampling was employed to distribute an on-line questionnaire, leveraging both accessible networks and referrals to reach a broader and relevant pool of stakeholders.
RESULTS: Of the 1,146 valid responses across the country, 94.9% (1,088/1,146) recognized the value of PROs in evaluating treatment efficacy, identifying unmet patient needs (69.6%), guiding physicians in disease management (70.0%), providing timely treatment feedback (79.5%), and enhancing doctor-patient communication (77.5%). Among 745 participating professionals with COA/PRO experience, challenges including insufficient localization of PRO measures (60.1%), accuracy of PRO during remote follow-ups (54.8%), and clinicians’ limited understanding on applying PRO results (47.7%) were identified. Most professionals with experiences in eCOA/ePRO were satisfied (71.1%) with current solutions, with concerns in using electronic devices (462, 80.6%), motivating patients to complete forms (373, 65.1%), technical issues (336, 58.6%), data integrity (293, 51.1%), insufficient patient training (252, 44.0%), and data protection through electronic means (153, 26.7%). Three-fourths of participating professionals planned use of eCOA/ePRO in the future.
CONCLUSIONS: The findings highlight the critical need for enhanced localization, robust technical support, ensured data integrity and safety, and seamless integration with existing systems to optimize the efficacy of eCOA/ePRO in China. The comprehensive overview of the current landscape and future potential of eCOA/ePRO implementation can facilitate broader adoption and improved outcomes in clinical and real-world settings.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD188
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas