BEHIND THE SCENES OF A

CLINICAL TRIAL
DISCOVERY PRECLINICAL RESEARCH
Researchers discover new drugs through …
+ DEVELOPMENT, FDA
Researchers conduct
experiments to gather
information …

BASIC RESEARCH n Isolate cell/tissue

outside living organism
Researchers conduct experiments
to gather information … n Test drug on living organism

n Potential benefits

n Investigative new drug

n Existing treatments n The best dosage application (fda reviews)
n Technology n R eports of problems
n New insights (can take years)
n Tests

n Side effects
n  he best way to give
T
the drug or therapy

CLINICAL
Clinical trials are conducted in four different phases with each phase
serving a specific purpose to researchers.

PHASE 1 PHASE 2 PHASE 3 PHASE 4

Assess the safety This phase helps Researchers gather
of a new drug. confirm the effectiveness additional safety information
of the drug, gauge side on an even larger group
effects and gather of people.
information so the drug n  ather data on long-term
G
or treatment can be
effectiveness and affect
used safely.
on quality of life.
n  valuated for cost and
E
n  est drug on small
T against other similar drugs.
group of people n  eceives FDA approval
R
(20 to 80) n  he drug or treatment
T and is widely marketed.
is given to a larger group
n  valuate how the body
E
(100 to 300) n  undreds or even thousands
H
handles the drug
(300–3,000) of people
may receive a new drug
or treatment and be
followed for several years.

n Determine effectiveness
n Safe dosage ranges n Continue to evaluate safety
n Record side effects