New consideration for data collection and application of clinical research under the back-ground of ligalization of data administration in China / 中华消化外科杂志

The medical data processed and analyzed in clinical research often contain a large number of personal information. Therefore, researchers should pay attention to the safety management of medical data during clinical research. The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1 st September and 1 st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security, which indicate that data governance has entered the 'strong regulatory era'. In the process of medical data collection and application of clinical research, respecting and protecting the privacy and safety of patients, ensuring the quality of medical data, safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.

<b>The Use of SS-MIX in Clinical Trials and Postmarketing Studies： From the View of Pharmaceutical Industries </b> / 薬剤疫学

Those of us in the pharmaceutical industry are in favor of using SS-MIX standardized storage to alleviate the burden on medical professionals. As previously suggested, in addition to the benefits of reducing study periods, supporting a variety of investigative research and safety measures, and obtaining more accurate data on disease states and treatments, actively using this kind of new technology is a societal imperative in an information-driven society. Possible practical uses include (1) general application in drug use surveillance and special drug use surveillance, (2) appropriate sampling surveys, (3) patient monitoring, (4) observational studies with controls, such as those using disease registries, and (5) reviewing the results of safety measures. However, there is the issue of regulatory interpretation and consensus, with debate on information protection, and the issue of social infrastructure. Therefore, industry, government, and academia must continue its active, cooperative discussion to enable true implementation of this technology. (Jpn J Clin Pharmacoepidemiol 2013; 18(1): 57-64)