Laboratory of Clinical Pharmacoepidemiology

Patient data obtained from daily clinical practice; real-world data (medical information databases) can be broadly classified into three categories.
Patient registry databases
Insurance databases
Medical information databases, including electronic medical information　
The Laboratory of Clinical Pharmacoepidemiology focuses on the electronic medical information database system and conducts various pharmacoepidemiological studies using this system.
 

Among currently approved drugs, only a limited number have pediatric dosage and administration specified in the package insert and are in approved clinical use. The dosage and administration of a drug should be determined rationally based on the results of clinical trials. One of the primary reasons for this is that it is more challenging to conduct clinical trials in children than in adults because it is necessary to consider changes in pharmacokinetics and exposure-response relationships according to the child's developmental stage. Even when clinical trials are conducted, they are often limited to a limited number of patients, and it is complicated to obtain sufficient information to determine dosage and administration. Therefore, in recent years, mathematical and statistical models have been used to predict pharmacokinetics and exposure-response relationships in pediatric patients to determine dosage and administration instead of clinical trials. However, at this point, no systematic model shows the pharmacokinetics and exposure-response relationships between drugs and diseases in children.
The Laboratory of Clinical Pharmacoepidemiology is researching information used in developing pediatric drugs in Japan to contribute to appropriate drug treatment for children.
 

Schemes for clinical research and clinical trials by researchers fall into three main categories: 1) "clinical trials" according to "GCP," 2) "clinical research" according to the "Clinical Research Act," and 3) "clinical research" according to the "Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects. All codes are continuously reviewed and updated in response to scientific advances and changes in the research environment. Although the main purpose of these reviews is to "promote appropriate research" in line with reality, it is not easy to correctly interpret their contents and appropriately conduct clinical research.
The Laboratory of Clinical Pharmacoepidemiology undertakes research that promotes high-quality and appropriate clinical research by analyzing issues faced by researchers and others to ensure that clinical research designed and conducted in the medical field is concluded appropriately and in compliance with clinical research norms.