CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW

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CLINICAL TRIAL
SURVIVAL ANALYSIS
OVERVIEW
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CLINICAL TRIAL
SURVIVAL ANALYSIS
OVERVIEW
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CONTENTS

1. Clinical Trials

3. Phase 3

2. Phase 1

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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
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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
P…(생략)