Abstract
ObjectiveTo investigate the gap between real-world data and clinical research initiated by doctors in China, explore the potential reasons for this gap and collect different stakeholders’ suggestions.DesignThis qualitative study involved three types of hospital personnel based on three interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.SettingSix tertiary hospitals (three general hospitals and three specialised hospitals) in Beijing, China, were included.ParticipantsIn total, 42 doctors from 12 departments, 5 information technology managers and 4 clinical managers were interviewed through stratified purposive sampling.ResultsElectronic medical record data cannot be directly downloaded into clinical research files, which is a major problem in China. The lack of data interoperability, unstructured electronic medical record data and concerns regarding data security create a gap between real-world data and research data. Updating hospital information systems, promoting data standards and establishing an independent clinical research platform may be feasible suggestions for solving the current problems.ConclusionsDetermining the causes of gaps and targeted solutions could contribute to the development of clinical research in China. This research suggests that updating the hospital information system, promoting data standards and establishing a clinical research platform could promote the use of real-world data in the future.
Funder
National Science and Technology Major Project of China
Reference53 articles.
1. Administration USFaD . Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration, 2017. Available: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices
2. Administration USFaD . Framework for FDA’s Real-World Evidence Program: Food and Drug Administration, 2018. Available: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
3. Real world evidence: experience and lessons from China
4. Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness
5. Patients in Context — EHR Capture of Social and Behavioral Determinants of Health
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