ABSTRACT
The common data model (CDM) has found widespread application in healthcare studies, but its utilization in cancer research has been limited. This article describes the development and implementation strategy for Cancer Clinical Library Databases (CCLDs), which are standardized cancer-specific databases established under the Korea-Clinical Data Utilization Network for Research Excellence (K-CURE) project by the Korean Ministry of Health and Welfare. Fifteen leading hospitals and fourteen academic associations in Korea are engaged in constructing CCLDs for 10 primary cancer types. For each cancer type-specific CCLD, cancer data experts determine key clinical data items essential for cancer research, standardize these items across cancer types, and create a standardized schema. Comprehensive clinical records covering diagnosis, treatment, and outcomes, with annual updates, are collected for each cancer patient in the target population, and quality control is based on six-sigma standards. To protect patient privacy, CCLDs follow stringent data security guidelines by pseudonymizing personal identification information and operating within a closed analysis environment. Researchers can apply for access to CCLD data through the K-CURE portal, which is subject to Institutional Review Board and Data Review Board approval. The CCLD is considered a pioneering standardized cancer-specific database, significantly representing Korea's cancer data. It is expected to overcome limitations of previous CDMs and provide a valuable resource for multicenter cancer research in Korea.
ABSTRACT
Data warehousing is the most important technology to address recent advances in precision medicine. However, a generic clinical data warehouse does not address unstructured and insufficient data. In precision medicine, it is essential to develop a platform that can collect and utilize data. Data were collected from electronic medical records, genomic sequences, tumor biopsy specimens, and national cancer control initiative databases in the National Cancer Center (NCC), Korea. Data were de-identified and stored in a safe and independent space. Unstructured clinical data were standardized and incorporated into cancer registries and linked to cancer genome sequences and tumor biopsy specimens. Finally, national cancer control initiative data from the public domain were independently organized and linked to cancer registries. We constructed a system for integrating and providing various cancer data called the Korea Cancer Big Data Platform (K-CBP). Although the K-CBP could be used for cancer research, the legal and regulatory aspects of data distribution and usage need to be addressed first. Nonetheless, the system will continue collecting data from cancer-related resources that will hopefully facilitate precision-based research.