In April 2006, ASCO submitted comments to the Food and Drug Administration (FDA) regarding its draft guidance entitled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." ASCO made comments generally supportive of the draft guidance and highlighted issues related to (1) protocol design, (2) missing data, (3) performance of daily activities, (4) PRO instruments in unblinded studies, (5) minimum important difference, (6) conceptual framework, and (7) toxicity data.
