> PE > PE Study Design1. Study design
To evaluate the causality between a drug and an adverse event, we monitor and observe the case and control groups of a study and we use research designs like cohort (all users of a drug are identified and followed up to determine what events or ADRs occur) and case-control study (all cases of the disease are identified and the use of the drug of interest is compared with controls without the disease).
| Intervention | Study designs | Classification (causal relationship) |
Convincing power |
|---|---|---|---|
| Observational study | Case report | Descriptive study (Association) |
very weak |
| Case series study | |||
| Cross-sectional study | |||
| Case-control study | Analytic study (Causation) |
||
| Cohort study | |||
| Experimental study |
Randomized clinical trial | very strong |
2. Data collection
To conduct a pharmacoepidemiologic study, we collect data directly or analyze databases such as health insurance claims database, hospital EMR database, and national statistics mortality data.
1) Collection of data
We conduct in-depth studies on drug exposure, adverse events, confounding factors, and etc.
-We directly collect data on about adverse events if necessary. Such cases include over-the-counter drugs, drugs not covered under national health insurance, and adverse events without diagnostic codes
-We also use drug registry data, which contain information on the drug users and adverse events, for causality assessments.
2) Analysis using other databases
Advantages of using other databases include their representativeness of a large population, high validity, and efficiency.
-We can analyze associations among drug use, cancer risk and death by linking different databases.
-Recently, we conducted pharmacoepidemiological studies using the Common Data Model(CDM). CDM is based on hospital data, and includes laboratory test results and drugs not covered by national health insurance.
3. Evaluation and Conclusion
We analyze the data to determine whether the suspected causal drugs actually had an effect on the outcome and generate drug safety information.