CLINICAL TRIAL SURVIVAL ANALYSIS OVERVIEW

_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 _SLIDE_7_ 3 methods in Phase 1 Standard Method Continual Reassessment Method(CRM) Accelerated Titration Design(ATD) Rule-based design proceeds with cohorts of three patients. If one of t…
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