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Clinical Trial Process
Clinical Trial Process
Overview
John O. Naim, Ph.D.
Director, Clinical Trials Research
Unit
West Virginia University
Mary Babb Randolph Cancer Center
What Is a Clinical Trial?
Effectiveness of intervention to treat a
disease
Safety of a new drug
Defining dose administration
Testing drug formulation
Exploring combination therapies
Evaluating effect of therapies on quality of
life
Types of Clinical Trials
Treatment
– Test new approaches to treat a disease
Prevention
– What approaches can prevent disease
Early-detection/screening
– What are new ways to find hidden disease
Diagnostic
– How can new tests or procedures ID disease
Phases of Drug Development
Phase 1 Phase 2 Phase 3 Phase 4
No. of 15-30 <100 100 to Several
Participants thousands hundreds to
several
thousands