CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW
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작성일 22-11-16 17:20
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CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW
CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW
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CLINICAL,TRIAL,SURVIVAL,ANALYSIS,OVERVIEW,기타,레포트
Download : CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW.pptx( 20 )
_SLIDE_1_
CLINICAL TRIAL
SURVIVAL ANALYSIS
OVERVIEW
_SLIDE_2_
CLINICAL TRIAL
SURVIVAL ANALYSIS
OVERVIEW
_SLIDE_3_
CONTENTS
1. Clinical Trials
3. Phase 3
2. Phase 1
_SLIDE_4_
WHY CLINICAL TRIAL
Effectiveness of intervention to treat a disease
Safety of a new drug or device
Defining dose administration
Testing drug formulation
Exploring combination therapies
Evaluating effect of therapies on quality of life
_SLIDE_5_
BRIEF OF PHASES
Phase 1
Phase 2
Phase 3
Phase 4
No. of Participants
15-30
100-300
100 to thousands
Several hundreds to several thousands
Purpose
First in humans
safe dose
POC
1/3 fail
Determine efficacy
Safety
50% fail
Compare new agent with standard treatment
Safety
1/3 fail
Post market
Long-term safety and efficacy
_SLIDE_6_
PHASE 1
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3 methods in Phase 1
Standard Method
Continual Reassessment Method(CRM)
Accelerated
Titration
Design(ATD)
Rule-based design
proceeds with
cohorts of t…(省略)
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