Patient-Reported Outcome Alerts Ethical and Logistical Considerations in Clinical Trials
Derek Kyte, Heather Draper, Melanie Calvert
The assessment of patient-reported outcomes (PROs) in clinical trials poses a number of potential problems. What happens when a patient reports a severe symptom and no one is monitoring that information; for example, when questionnaires are not reviewed until the end of a study? Do hospitals or researchers face liability if a patient reports suicidal thoughts on a questionnaire? http://jama.jamanetwork.com/article.aspx?articleid=1741830