Enum: StudyPhaseEnum

Clinical trial phases per FDA and NIH definitions

Permissible Values

Value	Meaning	Description
EARLY_PHASE_1	NCIT:C54721	Exploratory trials before traditional Phase 1
PHASE_1	NCIT:C15600	Initial safety and dosage studies
PHASE_1_2	NCIT:C15694	Combined Phase 1 and Phase 2 trial
PHASE_2	NCIT:C15601	Efficacy and side effects studies
PHASE_2_3	NCIT:C49686	Combined Phase 2 and Phase 3 trial
PHASE_3	NCIT:C15602	Efficacy comparison with standard treatment
PHASE_4	NCIT:C15603	Post-marketing surveillance
NOT_APPLICABLE	NCIT:C48660	Not a phased clinical trial

Slots

Name	Description
study_phase	Clinical trial phases per FDA and NIH definitions

Identifier and Mapping Information

Schema Source

from schema: https://w3id.org/linkml/valuesets

LinkML Source

name: StudyPhaseEnum
description: Clinical trial phases per FDA and NIH definitions
from_schema: https://w3id.org/linkml/valuesets
rank: 1000
permissible_values:
  EARLY_PHASE_1:
    text: EARLY_PHASE_1
    description: Exploratory trials before traditional Phase 1
    meaning: NCIT:C54721
    annotations:
      aliases:
        tag: aliases
        value: Phase 0
    title: Phase 0 Trial
  PHASE_1:
    text: PHASE_1
    description: Initial safety and dosage studies
    meaning: NCIT:C15600
    annotations:
      participants:
        tag: participants
        value: 20-100
    title: Phase I Trial
  PHASE_1_2:
    text: PHASE_1_2
    description: Combined Phase 1 and Phase 2 trial
    meaning: NCIT:C15694
    title: Phase II/III Trial
  PHASE_2:
    text: PHASE_2
    description: Efficacy and side effects studies
    meaning: NCIT:C15601
    annotations:
      participants:
        tag: participants
        value: 100-300
    title: Phase II Trial
  PHASE_2_3:
    text: PHASE_2_3
    description: Combined Phase 2 and Phase 3 trial
    meaning: NCIT:C49686
    title: Phase IIa Trial
  PHASE_3:
    text: PHASE_3
    description: Efficacy comparison with standard treatment
    meaning: NCIT:C15602
    annotations:
      participants:
        tag: participants
        value: 300-3000
    title: Phase III Trial
  PHASE_4:
    text: PHASE_4
    description: Post-marketing surveillance
    meaning: NCIT:C15603
    annotations:
      note:
        tag: note
        value: After FDA approval
    title: Phase IV Trial
  NOT_APPLICABLE:
    text: NOT_APPLICABLE
    description: Not a phased clinical trial
    meaning: NCIT:C48660
    annotations:
      note:
        tag: note
        value: For observational studies, device trials, etc.