PRO/COA development and validation

A patient-reported outcome (PRO) measure (sometimes known as a PROM) is the tool or instrument used to collect PRO data. These can include:

  • Symptom specific questionnaires
  • Disease specific questionnaires
  • General health questionnaires
  • Patient Global Impression of Change/Patient Global Impression of Severity
  • Electronic PROs (ePROs)
  • Single item numerical rating scales (NRS)
  • Daily diaries

Our expertise

At DRG Abacus, our dedicated Clinical Outcomes Assessment (COA) team have extensive experience in the design, validation, and implementation of PRO measures to support clinical trial endpoints. Our methodological approach reflects the Food and Drug Administration (FDA) PRO guidance to industry and learnings from European Medicines Agency (EMA) reflection papers.

The first step in our approach is to help you identify and review existing PROs in line with FDA and EMA regulatory guidance to understand:

  1. What PROs are currently available in this disease area to measure key concepts of interest (COI)?
  2. Is the evidence for content and psychometric validity adequate to support primary/secondary/exploratory endpoints?
  3. Are thresholds for clinically important differences/minimum clinically important differences (MCID) available to help interpret our clinical trial findings?
  4. What evidence gaps exist and what research is needed to support validity?

Our methods

Our COA experts can design qualitative, quantitative, and mixed methods research studies to generate evidence for validity or support the full development and validation of new PROs:

  • Concept elicitation interviews with patient, caregivers, and clinicians
  • PRO item generation
  • Cognitive debriefing interviews
  • Psychometric validation
  • Identifying clinically important change thresholds through qualitative and quantitative studies
  • PRO Evidence Dossiers to support regulatory submissions

We are part of Clarivate, a global leader in providing trusted insights and analytics to accelerate the pace of innovation.

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