Clinical data standards and the new world of research science, technology, and data sources

Abstract

More than 20 years ago, data scientists, statisticians, and researchers met to develop the data standards to facilitate the submission of clinical research results to the regulatory authorities; it is the beginning of the Clinical Data Interchange Standards Consortium (CDISC). The data to prove the safety of medicines and medical devices has wide-ranged requirements concerning the origin of data, methods of data collection, data tabulation method, consistency of contents. So CDISC has various standards such as SEND, CDASH, SDTM, ADaM, and ODM to support clinical research protocol. As a result of collaborating with other researcher groups and maintaining the standard, it has been endorsed by regulators around the world and has become the global standard for clinical research. The Pharmaceuticals and Medical Devices Integration Agency (PMDA) in Japan, and the U.S. Food and Drug Administration (FDA) in the United States make the obligation to the submission of clinical trial data with CDISC standards. Furthermore, in recent years, the CDISC Library in machine-readable format has been released so that the developers can automatically generate programs and data conforming to the CDISC standard, and implementation trials with CDISC Library are being conducted by volunteers of the CDISC 360 project. The scope of CDISC is extended to general clinical research now. Therapeutic Area User Guides (TAUGs) covers clinical research on tumors, vascular diseases, neurological diseases, infections etc. The National Cancer Institute (NCI), the world's largest funding agency, built the Cancer Data Research Commons (CDRC), the platform for sharing data submitted by researchers. The stored data is required to comply with CDISC standards. As the CDISC standard is the comprehensive standard for data quality control and research management, it is infiltrating all area related to medical research that develop new, safe, and effective medical devices and treatment methods. CDISC may contribute to further acceleration to research and development. Real Word Data (RWD) also tends to have low quality, but it is expected that quality will be improved by incorporating CDISC standards into management of these data. CDISC is taking into consideration the use of observational research.