Trends in EMA and FDA Labeling Based on Patient-Reported Outcomes (PROs)
A recent review of labels from European Medicines Agency (EMA)- and US Food & Drug Administration (FDA)-approved drugs for cancer found that the two agencies use differing evidentiary standards when evaluating evidence from patient-reported outcomes (PROs) in cancer clinical trials. Study sponsors pursuing PRO drug labeling who understand these differences can use that knowledge to guide their PRO measurement strategy.
This webinar, hosted by study authors and based on PRO labeling of cancer treatment drugs, focuses on key differences between the two regulatory agencies. Popular myths will be debunked, oncology studies inefficiencies will be exposed, and emerging trends will be highlighted to help sponsors pursuing labeling claims from both agencies
• What are the main characteristics of the labels granted by the FDA and the EMA for PRO-related endpoints, including feedback on specific outcome measures?
• What are the main challenges sponsors face when including PRO-related endpoints in cancer clinical research? And how can these challenges be overcome?
• What are the emerging oncology labeling trends in the regulatory environment?