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Measurement in Clinical Trials: An Examination of the FDA Position on the Review of Clinical Outcome Assessments (COAs)


  • Emuella  Flood

    Emuella Flood

    • Director, Patient-Reported Outcomes
    • AstraZeneca, United States

    Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca, Emuella was Senior Principal of Patient-Centered Outcomes (PCO) for ICON Clinical Research, where she led the US East Coast PCO research team, providing strategy and guidance to capture the patient experience.

  • Cicely  Kerr, PhD, MSc

    Cicely Kerr, PhD, MSc

    • Lead Outcomes Researcher, Patient Reported Outcomes
    • ICON plc, United Kingdom

    Cicely Kerr has extensive health research experience from patient reported outcome (PRO) consultancy and academic contexts. Areas of expertise include qualitative methods, concept elicitation, cognitive debriefing, PRO/other clinical outcome assessment (COA) validation, PRO/COA instrument review and gap analyses. She is a member of the DIA Study Endpoint Community ISOQOL Industry Advisory Committee and has run training workshops in PRO instrument development at leading international conferences.

  • April N. Naegeli, DrPH, MPH

    April N. Naegeli, DrPH, MPH

    • Senior Research Scientist, Global Patient Outcomes and Real World Evidence
    • Eli Lilly and Company, United States

    April is an epidemiologist who works at Eli Lilly and Company with a focus on questionnaire development. She co-leads the Rheumatoid Arthritis Working Group within the C-Path PRO Consortium, a collaborative working group between the pharmaceutical industry and FDA to evaluate and improve PROs for use in clinical interventional studies. In her position at Eli Lilly she is a senior research scientist in the Health Outcomes group working to evaluate the responsiveness of PROs in clinical trials.