FDA는 U.S. Department of Health and Human Service(미국 보건복지부)의 산하기관으로서 미국에서 가장 역사가 깊고 가장 신임 받는 소비자 보호기관 중의 하나이다.
FDA의 가장 중요한 역할은 소비자가 사용하는 제품에 대하여 안전성과 효율적인 생산, 유통, 판매 등을 관리하여 공중위생을 보호하는 것이며 소비
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.
Clinical test
Clinical trial is limited to human, therefore it is the precondition that ensuring ethicality with scientific validity of study.
Necessity of Clinical test
- Developing a new drug for Korean inherited trait
- Offering the earliest opportunity to patients
- Strengthening the capability of researchers
- Clinical trial has high added value
It is a plan th
three more patients will be treated.
Continual Reassessment Method(CRM)
All patients are
treated maximum tolerated dose.
(MTD)
The original CRM allowed for multiple dose escalations and de-escalations.
Accelerated
Titration
Design(ATD)
Standard design is used after the accelerated phase as a stopping rule.
Estimate the MTD with all toxicity data collected during the trial.
Necessity of Clinical test
- Developing a new drug for Korean inherited trait
- Offering the earliest opportunity to patients
- Strengthening the capability of researchers
- Clinical trial has high added value
It is a plan that recorded specific details
· How clinical trials should be performed
Including all aspects of the research study
· participant inclusion / exclusion