Enum: SurrogateEndpointValidationLevelEnum

BEST-aligned regulatory validation level inferred or curated for a surrogate endpoint

URI: dismech:enum/SurrogateEndpointValidationLevelEnum

Permissible Values

Value	Meaning	Description	Additional Info
VALIDATED_SURROGATE_ENDPOINT	None	Supported by clinical data providing strong evidence that the endpoint predic...	Title: Validated surrogate endpoint
REASONABLY_LIKELY_SURROGATE_ENDPOINT	None	Supported by strong mechanistic and/or epidemiologic rationale, but without s...	Title: Reasonably likely surrogate endpoint
CONTEXT_DEPENDENT_SURROGATE_ENDPOINT	None	Validation and approval pathway depend on context of use, disease setting, ef...	Title: Context-dependent surrogate endpoint

Slots

Name	Description
endpoint_validation_level	BEST-aligned validation level inferred or curated for the surrogate endpoint

Identifier and Mapping Information

Schema Source

• from schema: https://w3id.org/monarch-initiative/dismech

LinkML Source

name: SurrogateEndpointValidationLevelEnum
description: BEST-aligned regulatory validation level inferred or curated for a surrogate
  endpoint
from_schema: https://w3id.org/monarch-initiative/dismech
rank: 1000
permissible_values:
  VALIDATED_SURROGATE_ENDPOINT:
    text: VALIDATED_SURROGATE_ENDPOINT
    description: Supported by clinical data providing strong evidence that the endpoint
      predicts clinical benefit
    title: Validated surrogate endpoint
  REASONABLY_LIKELY_SURROGATE_ENDPOINT:
    text: REASONABLY_LIKELY_SURROGATE_ENDPOINT
    description: Supported by strong mechanistic and/or epidemiologic rationale, but
      without sufficient clinical validation for full surrogate validation
    title: Reasonably likely surrogate endpoint
  CONTEXT_DEPENDENT_SURROGATE_ENDPOINT:
    text: CONTEXT_DEPENDENT_SURROGATE_ENDPOINT
    description: Validation and approval pathway depend on context of use, disease
      setting, effect size, duration, residual uncertainty, and available therapy
    title: Context-dependent surrogate endpoint