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Global regulators enable sponsors to accelerate rare disease therapies with fast track considerations, but don’t provide guidance on how to modify study designs to accommodate progressive disease states, rater changes and other special considerations. This webcast will review current literature, highlight global regulations and ISPOR recommendations, and educate attendees on the parameters for using PRO/eCOA in rare disease studies.Presenters also will share how to manage eCOA study design, placebo effect and rater training.
Susan M. Dallabrida, PhD
Vice President of Clinical Science & Consulting Services
Katy Benjamin, MSW, MS, PhD
ICON Commercialisation & Outcomes