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The emerging role of real-world data in oncology care in Japan
H Bando1,2, E Tajima3, Y Aoyagi4
1Division of Drug and Diagnostic Development Promotion, Department for the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East, Kashiwa, Chiba.
Abstract:
While the number of newly approved anticancer therapies has increased substantially in the past decade, there remains a need to bring effective treatments to patients more efficiently. In the United States and Europe, real-world data (RWD) are being utilized widely, including in regulatory submissions to assess the potential benefits of therapies in development and address the unmet needs of the patients with limited treatment options. In Japan, given the volume of annual new cancer cases and region-specific circumstances, oncology RWD are crucial for improving patient access to effective therapies. The development of such RWD is underway; a notable recent example is the use of the SCRUM-Japan Registry as a source of external control data in the regulatory approval of pertuzumab and trastuzumab for patients with HER2-positive metastatic colorectal cancer. In addition, electronic health records-based longitudinal, patient-level RWD in Japan are being curated by Flatiron Health K.K. (FHKK), the Japanese subsidiary of Flatiron Health, Inc., by leveraging both structured and unstructured data-processing methodologies developed in the United States over the past decade and tailoring the approach to local requirements. FHKK, in partnership with one of the flagship cancer hospitals in Japan, the National Cancer Center Hospital East (NCCHE), is constructing patient-level RWD in gastrointestinal and other cancers; the first datasets in gastrointestinal cancers will be provided in late 2023. 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 lives of people with cancer.
Insights
Real-world data (RWD) in Japan is crucial for accelerating cancer treatment approval and improving patient access. Oncology RWD, including electronic health records, are being developed to enhance cancer care efficiency.
Area of Science:
- Oncology
- Real-World Data (RWD)
- Health Informatics
Background:
- The approval of novel anticancer therapies has surged, yet efficient patient access to effective treatments remains a challenge.
- Real-world data (RWD) is increasingly used in the US and Europe for regulatory submissions and to address unmet patient needs.
- Oncology RWD is particularly vital in Japan due to high cancer incidence and specific regional factors.
Purpose of the Study:
- To highlight the growing importance and development of oncology RWD in Japan.
- To showcase examples of RWD utilization in regulatory processes and data curation efforts.
- To emphasize the potential of RWD to improve patient access to effective cancer therapies.
Main Methods:
- Leveraging the SCRUM-Japan Registry for external control data in regulatory approvals.
- Curating longitudinal, patient-level RWD from electronic health records using advanced data processing.
- Collaborating with institutions like the National Cancer Center Hospital East (NCCHE) to build comprehensive datasets.
Main Results:
- The SCRUM-Japan Registry has been used as external control data for pertuzumab and trastuzumab approval in HER2-positive metastatic colorectal cancer.
- Flatiron Health K.K. (FHKK) is developing patient-level RWD from electronic health records, with initial gastrointestinal cancer datasets expected in late 2023.
- These efforts are establishing a foundation for robust oncology RWD in Japan.
Conclusions:
- The development and utilization of oncology RWD in Japan are progressing, exemplified by regulatory successes and ongoing data curation projects.
- Continued expansion of RWD depth and breadth is planned to further enhance cancer treatment efficacy and patient outcomes.
- Oncology RWD holds significant promise for improving patient access to timely and effective cancer care in Japan.
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