Our summary
In the field of oncology, the limitations of traditional approaches for evidence generation through randomized controlled trials in drug development are increasingly recognized amidst the rapid pace of innovation. This paper, co-authored by the National Cancer Center Hospital East (NCCHE) and Flatiron Health Japan, explores the pivotal role that electronic health records (EHR)-based RWD plays in addressing such challenges. The authors review the currently available RWD sources in Japan, recent examples of RWD utilization in local regulatory submissions, and introduce Flatiron’s collaboration with NCCHE as part of its efforts to curate EHR-based oncology RWD in Japan. This partnership is focused on constructing RWD across various tumor types to address existing gaps in data availability and quality. Flatiron’s approach, which uniquely combines clinical expertise and software engineering to process structured and unstructured data obtained from the EHR and other hospital information systems effectively, is also showcased.
Despite challenges like strict data privacy regulations in Japan, Flatiron has adapted its methodologies and unique approach of combining clinical expertise and software engineering to process structured and unstructured data obtained from the EHR and other hospital information systems effectively to meet local requirements. The first datasets in gastrointestinal cancers will be made available by late 2023, and as the curation of oncology RWD in Japan progresses, continuous expansion of the depth and breadth of the data is planned to improve and extend the lives of people with cancer.
Why this matters
The global cancer challenge necessitates innovative solutions for evidence generation in oncology. Flatiron's approach, especially in Japan with NCCHE as our first strategic site partner, addresses the urgency of creating fit-for-purpose RWD to enhance research, patient care, and regulatory decision-making. The joint effort not only navigates challenges posed by data privacy regulations but also aims to bring meaningful impact to the lives of those living with cancer, by generating robust evidence to inform treatment plans, drug development and regulatory decision-making. The potential for broadening collaboration and engaging with regulatory authorities underscores the commitment to shaping a robust RWD infrastructure to extend and improve the lives of individuals affected by cancer.