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Class: ClinicalTrialAndRegulatoryApprovalContextMixin

Description: A mixin providing the clinical trial and regulatory approval context of an association between an entity (typically a chemical, drug, or treatment) and the disease or phenotypic feature it is used, or is being studied, to treat. These slots are association-scoped: they describe the entity's status with respect to this particular indication. For the entity's overall regulatory status independent of any one indication, see the node properties 'highest FDA approval status' and 'drug regulatory status world wide'.
classDiagram class ClinicalTrialAndRegulatoryApprovalContextMixin ClinicalTrialAndRegulatoryApprovalContextMixin <|-- ChemicalOrDrugOrTreatmentToDiseaseOrPhenotypicFeatureAssociation ClinicalTrialAndRegulatoryApprovalContextMixin <|-- EntityToDiseaseAssociation ClinicalTrialAndRegulatoryApprovalContextMixin <|-- EntityToPhenotypicFeatureAssociation ClinicalTrialAndRegulatoryApprovalContextMixin : clinical_approval_status ClinicalTrialAndRegulatoryApprovalContextMixin --|> ClinicalApprovalStatusEnum : clinical_approval_status ClinicalTrialAndRegulatoryApprovalContextMixin : max_research_phase ClinicalTrialAndRegulatoryApprovalContextMixin --|> ResearchPhaseEnum : max_research_phase ClinicalTrialAndRegulatoryApprovalContextMixin : number_of_cases ClinicalTrialAndRegulatoryApprovalContextMixin : regulatory_approvals

Slots

Name Cardinality and Range Inheritance Examples
clinical_approval_status:
The clinical approval status of a chemical entity for treating a specific disease or condition, as captured in the context of the association between the chemical and the disease. 		0..1
ClinicalApprovalStatusEnum		 direct
max_research_phase:
The maximum research phase reached for a specific chemical-disease pair, indicating the highest clinical trial phase achieved for the chemical entity's investigation as a treatment for the associated disease or condition. 		0..1
ResearchPhaseEnum		 direct
regulatory_approvals:
Numbers or identifiers issued by regulatory agencies that identify specific drug applications or marketing authorizations. Values are application-number provenance and are not guaranteed to be verified identifiers from any particular agency; they may include FDA application numbers (for example, as seen with ranitidine having both ANADA200536 and ANDA200536) as well as identifiers from other regulatory agencies such as EMA marketing authorizations. Each drug can have multiple approval numbers. 		*
String		 direct
number_of_cases:
The number of cases in a study or clinical trial, primarily used in conversion of drug approval data. 		0..1
Integer		 direct

Mixin Usage

mixed into description
ChemicalOrDrugOrTreatmentToDiseaseOrPhenotypicFeatureAssociation This association defines a relationship between a chemical or treatment (or procedure) and a disease or phenotypic feature where the chemical or treatment is used to treat, or is being studied to treat, the disease or phenotypic feature.
EntityToDiseaseAssociation An association between any entity and a disease, capturing clinical context such as approval status, research phase, regulatory approvals, and number of cases.
EntityToPhenotypicFeatureAssociation An association between any entity and a phenotypic feature, capturing clinical context such as approval status, research phase, regulatory approvals, and number of cases.

LinkML Source

name: clinical trial and regulatory approval context mixin
description: 'A mixin providing the clinical trial and regulatory approval context
  of an association between an entity (typically a chemical, drug, or treatment) and
  the disease or phenotypic feature it is used, or is being studied, to treat. These
  slots are association-scoped: they describe the entity''s status with respect to
  this particular indication. For the entity''s overall regulatory status independent
  of any one indication, see the node properties ''highest FDA approval status'' and
  ''drug regulatory status world wide''.'
from_schema: https://w3id.org/biolink/vocab/
mixin: true
slots:
- clinical approval status
- max research phase
- regulatory approvals
- number of cases