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Session 7 Track E: What Happens to Patients as They use a Test Therapy: eCOA and Substantial Evidence of Clinical Benefit
Session Chair(s)
Stephen Raymond, PhD
Chief Scientist . eCOA
ERT, United States
Clinical Outcome Assessments include various reports on the status of patients in clinical trials, including diaries and questionnaires completed by patients about themselves as well as assessments made by observers, clinicians and/or caretakers. Capturing these assessments electronically rather than on paper forms makes information available in real time and also increases the quality of data. After 20 years of experience using more than 800 eCOA “instruments” in thousands of trials the scientific importance of a patient perspective is established. This session will review aspects of eCOA methods that relate to writing and ethics, particularly the challenges of writing both the content of the survey instruments and the programming of systems for capture, review, monitoring, analysis, and delivery of results. eCOA systems increasingly support oversight of patient conditions, triggering alerts on symptom worsening and trends that warrant attention by site investigators and/or data monitoring boards. What are the ethical implications? Clarity of writing is essential in order for assessments to make sense to those who complete them (content validity). Reviewers who allow claims need to know that the substantial evidence standard has been met. An intriguing case history will illustrate how meeting these challenges enable quantification of improvement in ways that justify market approval and inclusion in formularies.
Learning Objective : - Describe how clarity of writing applies to eCOA instruments, protocols, and project management
- Explain how measurement of feelings, symptoms, and behaviors may fail
- Identify how medical writers and ethicists can ensure that the content captured within eCOA is valid
Speaker(s)
Writing eCOA: Optimizing Trustworthiness and Sensitivity of Subjective Data
Stephen Raymond, PhD
ERT, United States
Chief Scientist . eCOA
Speaker
Jean Paty, PhD, MS
IQVIA, United States
Vice President, Patient-Centered Science
The eCOA Story of a New Drug From First Use in Humans to Post Approval Claims
Speaker Invited
United States
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