소개글
임상시험(Clinical Trial)에 대하여(영문)에 대한 자료입니다.
목차
1. Clinical Trials?
2. Phase 1
3. Phase 3
본문내용
3 methods in Phase 1
Standard Method
Rule-based design
proceeds with
cohorts of three
patients.
If one of the first
three patients
experiences toxicity, 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.