Preferred Label : Study Protocol Version Phase Code;
NCIt related terms : StudyProtocolVersion.phaseCode;
NCIt definition : A coded value specifying the designation of approval phase for a study.;
Alternative definition : BRIDG 3.0.3: A coded value specifying the designation of approval phase for a study.
EXAMPLE(S): I, I/II, II, III, N/A. NOTE(S): Studies are generally categorized into
four (sometimes five) phases described separately herein. An investigational medicine
or product may be evaluated in two or more phases simultaneously in different studies,
and some studies may overlap two different phases. Phase 1: The initial introduction
of an investigational new drug into humans. Phase 1 studies are typically closely
monitored and may be conducted in patients or normal volunteer subjects. Phase 2:
Controlled clinical studies conducted to evaluate the effectiveness of the drug for
a particular indication or indications in patients with the disease or condition under
study and to determine the common short-term side effects and risks associated with
the drug. Phase 3: Studies are expanded controlled and uncontrolled trials. They are
performed after preliminary evidence suggesting effectiveness of the drug has been
obtained, and are intended to gather the additional information about effectiveness
and safety that is needed to evaluate the overall benefit-risk relationship of the
drug and to provide an adequate basis for physician labeling. Phase 3b: Phase 3b studies
are a sub category of phase 3 trials near the time of approval to elicit additional
findings. Phase 4: Concurrent with marketing approval, Food and Drug Administration
(FDA) may seek agreement from the sponsor to conduct certain post-marketing (phase
4) studies to delineate additional information about the drug's risks, benefits, and
optimal use. Phase 5: Post-marketing surveillance is sometimes referred to as Phase
5.; BRIDG 5.3: A coded value specifying a stage in the progression of a therapy from initial
experimental use in humans in clinical trials to post-market evaluation. EXAMPLE(S):
I, I/II, II, III, N/A OTHER NAME(S): NOTE(S): Studies are generally categorized into
four (sometimes five) phases described separately herein. An investigational medicine
or product may be evaluated in two or more phases simultaneously in different studies,
and some studies may overlap two different phases. Phase 1: The initial introduction
of an investigational new drug into humans. Phase 1 studies are typically closely
monitored and may be conducted in patients or normal volunteer subjects. Phase 2:
Controlled clinical studies conducted to evaluate the effectiveness of the drug for
a particular indication or indications in patients with the disease or condition under
study and to determine the common short-term side effects and risks associated with
the drug. Phase 3: Studies are expanded controlled and uncontrolled. They are performed
after preliminary evidence suggesting effectiveness of the drug has been obtained,
and are intended to gather the additional information about effectiveness and safety
that is needed to evaluate the overall benefit-risk relationship of the drug and to
provide an adequate basis for physician labeling. Phase 3b: Phase 3b studies are a
sub category of phase 3 near the time of approval to elicit additional findings. Phase
4: Concurrent with marketing approval, Food and Drug Administration (FDA) may seek
agreement from the sponsor to conduct certain post-marketing (phase 4) studies to
delineate additional information about the drug's risks, benefits, and optimal use.
Phase 5: Post-marketing surveillance is sometimes referred to as Phase 5.;
Origin ID : C94118;
UMLS CUI : C2986316;
Semantic type(s)
- concept_is_in_subset
