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Applying the Argument-Based Approach to Validation With Clinical Outcome Assessments: Strategies for Constructing a

Kevin P Weinfurt1, R J Wirth2, Michael C Edwards3

  • 1Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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PubMed
Summary
This summary is machine-generated.

This study introduces two strategies to help researchers build valid arguments for interpreting clinical outcome assessment (COA) scores, aligning with FDA guidance for patient-focused drug development.

Keywords:
clinical outcome assessmentsfit-for-purposemeasurementpatient-focused drug developmentvalidity

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Area of Science:

  • Clinical trial methodology
  • Regulatory science
  • Psychometrics

Background:

  • The FDA's Patient-Focused Drug Development guidance promotes an argument-based approach to validating clinical outcome assessments (COAs).
  • This approach requires explicit rationales to support the interpretation of COA scores.
  • Researchers and sponsors need practical methods to construct these validation rationales.

Purpose of the Study:

  • To provide researchers and sponsors with practical strategies for developing argument-based validation rationales for COAs.
  • To offer initial, generic rationales for common COA types to facilitate their adaptation to specific contexts.

Main Methods:

  • Reviewing assessment processes to identify underlying assumptions.
  • Evaluating potential validity threats, including construct underrepresentation and irrelevance.
  • Developing generic rationales for patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), clinician-reported outcomes (ClinROs), and performance outcome (PerfO) measures.

Main Results:

  • Two complementary strategies for constructing validation arguments are presented.
  • Initial generic rationales are provided for four types of COAs.
  • These rationales are intended as starting points for context-specific adaptation.

Conclusions:

  • The proposed strategies and generic rationales can assist in building robust validation arguments for COAs.
  • Further discussion is needed to establish consensus on constructing and evaluating evidence-based rationales.
  • Validation is an iterative process that requires ongoing attention to pragmatic considerations.