Glossary of health medical data

Clinical Development/Clinical Trials

The practical application of a new drug or medical device candidate takes a long time and involves many steps. The stage in which clinical trials are conducted on human subjects is called clinical development. Clinical trials are conducted to confirm the efficacy and safety of a drug or medical device in humans in order to have it recognized as a drug or medical device by the government. (For more information, please refer to " Clinical Research for more information). The drug or medical device candidate is tested to determine whether it is safe and effective for patients, and in what quantities it is appropriate to use.

Clinical trials are divided into the following three steps and are conducted in hospitals and other medical institutions with the consent of healthy individuals and patients. Phase I is called Phase I, Phase II is called Phase II, and Phase III is called Phase III.

Phase 1 Phase I Target: A small number of healthy people* Safety checks including the absence of adverse events Phase 2 Phase II Target: A small number of patients Confirmation of effective and safe dosage and administration method Phase 3 Phase III Target: A large number of patients Comparison of efficacy and safety with reference drugs used up to now, etc. Phase III: To compare the efficacy and safety of the drug with those of the reference drugs, etc. used up to now *Cancer patients are often targeted because of the strong efficacy and side effects of anti-cancer drugs

Post-launch safety and usage checks

As a result of being used by many patients at medical institutions, information on side effects and proper usage that could not be detected during the development phase is collected by pharmaceutical company pharmaceutical information officers. Thus, various checks are obligatory even after a drug is launched.

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