OBJECTIVES: Real-world data (RWD) has been increasingly contributed to improved health outcomes. With the developing of EMR systems and medical big-data platforms, RWD can be well accessed currently through proper compliance procedures in China. Some digital platforms are developed to help the application of RWD, such as DPAP, a traceable and regulated Data Process & Application Platform for application of RWD in clinical research. This study was to investigate the project types using RWD derived from the DPAP for real world evidence (RWE) generation in post-marketing research.

METHODS: Projects applying RWD have been categorized into RWI (real-world insight), RWS (real-world study), and HEOR. RWI refers to descriptions of status quo of certain diseases and treatments. RWS refers to studies with clear research questions, and patient inclusion and exclusion criteria. HEOR stands for health economics and outcome research. Other types of projects include predictive modelling and advanced database analysis.

RESULTS: Among all the on-going and accomplished projects, 56% RWI, 35% RWS, 9% HEOR, and 1% other types. Especially, 80% of projects involved the analyses of treatment pattern or treatment flow, 70% of projects included patient journey analyses, and 30% projects compared and assessed the therapeutic effectiveness by different interventions. Studies were also designed to support drug developments and launches, unmet clinical needs evaluation, market analyses and access strategy, HTA preparation, and reimbursement negotiations. The disease areas involved in the projects were broad, from chronic diseases to severe malignant tumor, as well as from lung infections to surgical anesthesia.

CONCLUSIONS: The RWD derived from medical big-data platform have been widely and innovatively used for RWE generation in post-marketing research, provide more pragmatic research in real-world clinical practice, which has been well recognized by the pharmaceutical industry, reflecting the need for demonstrating the product value in real world settings.