Taiwan FDA published Guidelines for the Implementation of Drug Epidemiological Safety Research Using Electronic Health Care Data

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Real-world evidence is the latest international clinical application trend, which can be used to improve the design of clinical trials, and as an aid to the efficacy or safety of drugs before and after marketing. The majority of the countries focus on developing the application of real-world evidence and formulating relevant norms.

With reference to international management trends and domestic conditions, the “Guidelines for the Implementation of Drug Epidemiological Safety Research Using Electronic Health Care Data” is formulated for domestic drug development to follow.

Below is a summary of the guideline structure:

  • Introduction
    • Title and research abstract details
    • Research background
    • Consideration of research methods
    • Professional competence and certification of the research team
    • Interpretation of the research results
  • Sources of information
    • Appropriateness of data sources for the safety issue to be studied
    • The integrity of the patient’s entry into the database and care information
    • National sources of care systems and data
    • Selecting the target group for research
    • Quality assurance and quality control
    • Issues with the research time frame and delayed time
  • Research design
    • Overall consideration of research design
    • Definition of drug exposure and confirmation of exposure
    • Definition of Safety Results and Confirmation of Results Occurrence
  • Analytical method
    • Pre-defined analysis plan
    • Research and analysis methods
    • Use of Specific Statistical Methods
    • Sensitivity analysis
    • Linking or pooling different sources of information
    • Evaluation and processing of missing and uninterpretable data
    • Quality assurance and quality control
    • Procedures to ensure the accuracy of the data processing and analysis process
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