Clinical Outcomes Assessment

Clinical Outcomes Assessment

ICON’s Clinical Outcome Assessment (COA) services are geared to meet the demands of global and national markets for high quality patient-centered data. Our COA group brings together a large team of scientists and consultants with expertise in the selection, development, validation and analysis of Patient Reported Outcome (PRO) and other COA instruments. The group has a deep understanding of the marketplace and regulatory landscapes, and helps decision-makers to understand the value of patient endpoints and to estimate the impact of new health technologies.

The COA group has a comprehensive service portfolio, with services including:

  • Strategic advice on COA endpoints and trial design
  • Instrument selection, development, and validation
    • Patient-Reported Outcomes (PROs)
    • Clinician-Reported Outcomes (ClinROs)
    • Observer-Reported Outcomes (ObsROs)
    • Performance-based Outcomes (PerfOs)
  • Content validation - Qualitative research to establish content validity of new and existing measures
  • Psychometric validation
    • Classical test theory approaches
    • Modern test theory (IRT, Rasch)
  • Conceptual and Endpoint model development
  • Regulatory (e.g. FDA/EMA) support
    • Exploration and substantiation of labeling claims
    • Evidence dossiers and briefing books
    • Regulatory submission support
    • Meeting attendance
  • Systematic and focused literature reviews 
  • Observational research, including survey design
  • Medication adherence (compliance) studies
  • Patient preference studies, including conjoint studies/Discrete Choice Experiments (DCE)
  • Utility measurement, mapping and crosswalk studies 
  • COA clinical trial data analysis
  • eCOA validation and equivalence testing
  • Tailored client training - Training programs in outcomes measurement, methods and strategy

We offer an integrated and highly scalable approach:

  • Offices in multiple locations in the EU and North America
  • Network of international opinion leaders, regulatory experts, methodological and clinical experts
  • Collaborative relationships with key researchers at University of Oxford, University of Sheffield, University of Washington, and University of York
  • Active in leadership roles within: ISPOR including task force chairs, EuroQol, ISOQOL, and DIA

The COA group is closely integrated with all ICON divisions, working in close collaboration with other ICON services including:

  • Market Access and Reimbursement
  • Translation and Linguistic Services
  • eCOA
  • Health Economics
  • Epidemiology
  • Biostatistics

We thus have the capacity to support customer needs throughout the entire product development lifecycle, allowing for a single vendor option for reimbursement and regulatory matters relating to COAs:

  • Early stage exploration of product, health impact and value
  • Regulatory submission support
  • Exploration and substantiation of labelling claims
  • Market access and reimbursement strategies
  • Engagement in extensive external ‘knowledge sharing’ activities, including participation at ISPOR, ISOQOL, DIA, PCORI, EuroQol group and providing guidance to NICE.