Milestones – Seminar – Real world evidence and its applications in the era of COVID-19

National Yang-Ming Chiao Tung University’s Research Center for Epidemic Prevention and HOTTEA (Health Outcomes and Technology Teaching and Education Alliance, the first domestic organization focusing on promoting health technology assessment education, research, and related work), jointly held the “Real world evidence and its applications in the era of COVID-19” academic seminar on March 20, 2021.

Medical research has always relied on randomized clinical trials (RCTs) to provide scientific evidence. However, RCTs require large amounts of funding and and have a long follow-up time, making it difficult to meet the needs of policy and decision makers who require immediate sources of reference. Thus, many advanced countries have begun to utilize real-world data (RWD) and real-world evidence (RWE) for health technology assessments and health insurance reimbursement decisions. RWD refers to data collected during routine medical care, such as observational research, electronic medical records data (EMR), payment and pricing, product and disease registration, and patient data. RWE refers to evidence generated through the analysis of RWD that provides healthcare decision makers with key sources of reference. For instance, decision makers may want to study and analyze data for specific ethnic groups but existing trials lack sufficient evidence. RWE can save time and cost of collecting information for health technology assessments (HTA). Compared to RCTs, evidence from RWE has higher external validity and enables decision makers to be more certain of the safety, effectiveness, and cost-effectiveness of health technologies. Additionally, RWE can fill in evidence gaps left when RCTs cannot be implemented due to ethical or other limitations.

The seminar invited Dr. Hwee-Lin Wee, a professor from the University of Singapore, to share his experience developing the REALISE guidance document that was completed in 2020 and provide specific, pragmatic suggestions on the application of RWD and RWE in Taiwan for the future. Additionally, many domestic scholars were invited to share REALISE’s Taiwan experience and examples of RWD’s applications.

Dr. Allen Lien, Deputy Director of the Research Center for Epidemic Prevention, will give a keynote address on the “Extrapolation of Data Related to COVID-19 Vaccine’s Protective Effects.”