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