소개글
임상시험(Clinical Trial)에 대하여(영문)에 대한 자료입니다.
목차
Ⅰ. About Clinical Trial.
Ⅱ. Phase of Clinical Trials
Ⅲ. Ethical problem of Clinical trial and ICH-GCP
본문내용
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 called the "standard treatments." Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the KFDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.