Long-term follow-up studies of cell and gene therapies
Consider the basket design
Regulators typically expect that Sponsors collect up to 15 years of follow-up data on patients who’ve received cell and gene therapies either through a clinical trial or in clinical practice.
In designing such long-term follow-up (LTFU) studies, Sponsors can select from a number of models, however one in particular is emerging as a preferred design: the basket LTFU study.
Read the whitepaper for insights on:
- Concerns associated with CGTs
- Relevant regulations on follow-up
- LTFU study design options
- Success factors related to conducting basket LTFU studies