Approaches to Conducting Comparative Real-world Evidence (RWE) Studies to Inform Healthcare Decision-making


The use of RWE by regulatory, reimbursement and clinical practice decision-makers continues to evolve. There are many factors contributing to this including increasing access to large healthcare databases, advances in causal inference methods, and the development of federated analytic networks to support medical product monitoring. Comparative RWE studies – studies that compare the benefits or risks of two or more therapeutic interventions – can provide important information to guide decision-makers. But these studies are complicated and require a principled approach to design and execution. This should include efforts to ensure study validity and transparency, which can be achieved through a staged approach to study design and execution including the use of negative controls and contemporary causal inference methods, and the implementation of a clean room execution framework. These approaches will discussed and illustrated with two comparative studies in the osteoporosis disease area.


Keiko Asao
IQVIA Solutions Japan G.K.


Brian D. Bradbury
Vice President, Center for Observational Research (CfOR)


Keiko Asao
Keiko Asao is a Principal at IQVIA Solutions Japan G.K., where she is in charge of epidemiological research projects. She received her medical degree from Tohoku University and her PhD (epidemiology) from Johns Hopkins University in the United States. After about 20 years of clinical practice in internal medicine and endocrinology along with research activities in academic institutions in Japan and the United States, she shifted her career path to industry, starting at pharmaceutical companies in Japan, where, through collaborations within and across organizations, she promoted the use of real-world evidence to address various research questions throughout the products’ lifecycle. She has worked at IQVIA since 2022 and is heavily involved in research projects, including post-authorization safety studies, primarily for clients in the healthcare industry.
Brian D. Bradbury
Brian is Vice President and Head of the Center for Observational Research (CfOR) at Amgen Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) across the drug development lifecycle. His team manages Amgen’s real-world data (RWD) platform and has connected to it an integrated analytic capability to support disease epidemiology and the evaluation of the benefit:risk profile of Amgen’s medicines. His team collaborates with stakeholders across the healthcare ecosystem to advance the use of high-quality RWE to help inform decision-making and achieve Amgen’s mission to serve patients. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, and cancer, bone and kidney disease epidemiology.