Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

U.S. Food and Drug Administration. (2023). Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.

Type

Report

Intellectual base

Grey literature

Year

2023

Link

https://www.fda.gov/media/168351/download

Cited by

1 citation across 1 artifact.

Domain-specific

• Floor Effect
  • In clinical outcome assessment, regulators warn that a high proportion of least-severe responses can obscure improvement or treatment differences because affected respondents have no available lower score.

Verification

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Registry ID ref:3388d2dd6d61 · see in the full table