Abstract
Clinical Innovation Network (CIN) is a new strategy supported by Ministry of Health, Labour, and Welfare, Japan, to improve the initiative of clinical development. This strategy enables efficient clinical trial by utilizing patient registry that is a primary key source of Real World Data (RWD). CIN is a concept that promotes post-marketing surveillance and clinical trials. Since 2009, the muscular dystrophy patient registration system (Registry of Muscular Dystrophy: Remudy) is being operated. To use the registry internationally, it is necessary to set the same collection items. Standards on collection items are established from the Global Rare Disease Registry Data Repository (GRDR) in the United States and the European Union Committee of Experts on Rare Diseases (EUCERD) in Europe as the minimum collection items for the registry; however, there are no standards such as GRDR and EUCERD in Japan. Clinical Data Interchange Standard Consortium (CDISC) is a non-profit organization that proposes global standards for data sharing, exchange, reuse in medical research, and related areas of healthcare. CDISC has high versatility and defines CDISC standards applicable to clinical trial data of various diseases, diabetes, Alzheimer’s and so on. In 2017, CDISC also published the Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD) data category for Duchenne muscular dystrophy. In a cross-sectional study, problems such as missing data due to missing collection items and differences in responses for each study occur; therefore, it is important to use data standards such as CDISC standards for building registries. Considering the ease of data collection in clinics, it is crucial to have a viewpoint of both the clinical and data standards. Therefore, in order to promote the utilization of RWD, it is imperative to develop and disseminate international standards for registries. Currently, we are working on a survey and reviewing the international standards such as TAUG-DMD, GRDR, and EUCERD with an aim to standardize the collection items encompassing various patient registries.
