Workshop on long-term follow-up of participants in human gene transfer research.

first five years should include an annual physical exam, whereas data for years six through fifteen could be collected by a clinical questionnaire. Dr. Simek explained that the current workshop was designed to help participants gain an accurate understanding of the current FDA recommendations on LTFU and, through group discussions, to enable the FDA to receive feedback on ways to improve the current LTFU framework to improve human gene transfer clinical trial safety while promoting opportunities for product development.