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Clinical Trials
Ⅰ. About Clinical Trial.
1. Definition of clinical trials
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
2. Reason of clinical trial
A clinical trial is one of the final stages of a long and careful disease research process. Studies are done with disease patients to find out whether promising approaches to disease prevention, diagnosis, and treatment are safe and effective.
3. Purpose of clinical trials
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are cal…(생략)
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hes the tumor, how the drug acts in the human body, and how cancer cells respond to the drug. The patients in these studies must have extra biopsies, scans, and blood samples. The biggest difference between phase 0 and the later phases of clinical trials is that there is no chance the volunteer will be helped by taking part in a phase 0 trial. Because drug doses are low, there is also less risk to the patient in phase 0 studies compared with phase I studies. Phase 0 studies help researchers find out which drugs do not do what they are expected to do.
2. PhaseⅠ trials
Phase 1 executes initial clinical testing of new drug. The Phase1 major object is that defines safety dose quantity and evaluates appearance of drug feasibility. Phase 1 testing is usually designed based on clear pre-clinical test which proof the effect to animal. Generally patients who want to participant phase1 have malignancy disease has no effective medicine or remedy option. Important points of Phase 1 are defini
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