Background

National Evidence-based healthcare Collaborating Agency (NECA)  conducted a study through the collation of prospective/retrospective patient registration data and data with healthcare big data, including claims data and cancer registration data, to generate a basis for comparative effectiveness of various medical technologies and identify the economic value of improved clinical effects of the corresponding medical technology. As a result, a total of 33 types of data were constructed from 2015 to 2017, and clinical research data will be steadily constructed in addition to NECA's existing research projects.  In addition, the National Health Clinical Research Project was promoted to establish the basis for national clinical research materials from 2015 to 2017. A total of 17 types of patient registration datasets were collected using iCReaT (web-based Clinical Research and Trial) operated by the National Institute of Health in Korea Center for Disease Control and Prevention. In the future, these clinical research data are expected to be constructed with a large number of various patient data as the national health clinical research project continues. Therefore, it is necessary to diagnose a plan to utilize the established clinical research data efficiently.

Objective

One of the most common problems faced by researchers who perform conventional clinical and epidemiological studies is the lack of a sufficient number of subjects to test their hypotheses or fail to obtain statistically significant results. In this respect, if there is already established clinical research data and it can be used, it is meaningful in terms of utilization cost such as cost reduction and time saving. Currently, the major projects of the Korea Institute for Health and Medical Research are three projects: health care research, new medical technology evaluation, and national health clinical research. In carrying out these research projects, Although the research material is naturally constructed, there are some considerations to take advantage of it.

- First, legal issues related to patients' use of personal medical information

- Secondly, is the data that is worth building? The question of the value of the material in terms of content and the fulfillment of the physical factors such as the accuracy of the data.

- Third, how would you use available data? Therefore, practical considerations of  the value of the legal review and data is assessed for the diagnosis of the availability of the deployed clinical research data, and the practical use cases are presented based on the assessment of the value of the data.