Medical Affairs and Scientific Communications 2016 Annual Forum

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.