Professional Documents
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Clinical Trial Process
Clinical Trial Process
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
Personnels Involved
Cell studies
first tests done on a new treatment
human cancer cells or animal cancer cells.
Animal studies
tested next on cancers in live animals
Phase 0
First few people in the study get a very low dose and
monitored closely
what the drug does to the body and what the body does
with the drug.
Safety is the main concern
rare side effects may not be seen due to low sample
size
Placebos (inactive treatments) are not used in phase I
trials.
Include a small number of people (20-40)
ADME studies
Phase 2
DRAP
Clinical trials registry
Clinical trials subject registry
Therapies currently awaiting
approval
Diseases as candidates for
gene therapy
Trends in the use of vectors