A REAL-WORLD DATA (RWD) ROADMAP IN CHINA- CHALLENGES AND OPPORTUNITIES FOR IN VITRO DIAGNOSTICS (IVD)

Author(s)

Yan Xiao, DrPH, Population Health Sciences, Data Science and Services, Roche Diagnostics, Pleasanton, USA

Presentation Documents

ISSUE: Real-world evidence (RWE) can align practice and policy decisions closely with individual patient needs. How high-quality, complete, and accurate data are accessed to generate RWE in China is less well defined. The panel will present, debate, and reflect on challenges and opportunities of RWD from Chinese academic, government, provider, and IVD industry perspectives. Si Yan Zhan provides assessment of Chinese RWD governance, including stakeholders’ competing perspectives and how they may be overcome. Yan Xiao presents the current state of Chinese RWD, contrasting to other regions, and the case for industry partnership. Finally, Xiao Qing Liu argues trade-off value of RWE for hospitals and providers, including data sharing and patient privacy concerns. Each panelist speaks for 10 minutes followed by a 15-minute moderated discussion and 15 minute audience Q&A. OVERVIEW: Practice and policy decisions rely on evidence from RCTs that use narrow patient populations and circumscribed clinical settings, with limited heterogeneity. In China, RWD has developed to address these limitations out of a need to generate additional evidence to inform decision making. However, challenges remain, including data accessibility, sharing, and ethical approval. Data accuracy, completeness, and consistency are also barriers, with limited systematic technical guidance for data collection and quality control. And while concerns around patient confidentiality exist, data ownership is an obstacle to evidence generation with policies for data access, consent, and privacy lacking. Nevertheless, opportunity exists to leverage experience from other regions, where RWE is used to direct practice, regulatory approvals, and commercial business planning. Further infrastructure and leadership is necessary, with opportunities to offer industry, along with policy makers and institutions, capacity and expertise in framework development to capture and use RWD relevant to all stakeholders. This collaborative approach may offer a unifying voice among patients, providers, industry, and policy makers about the medical value of RWE.

Conference/Value in Health Info

2018-09, ISPOR Asia Pacific 2018, Tokyo, Japan

Code

IP9

Topic

Medical Technologies, Real World Data & Information Systems

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×