While stand-alone LTFU studies are not new, the models have evolved with the advent of potentially transformative therapies and treatments, including, but not limited to advanced therapy medical products, cellular products and gene therapies.
June 29, 2021
Clinical trials often include an extended post-study follow-up period, ranging anywhere from months to years to assess the long-term impact of the treatment. Long-term follow up (LTFU) studies are undertaken to address the needs of the scientific community, regulators or both. The LTFU phase of a study has traditionally been part of a single clinical trial, but we are now seeing a decoupling of this phase into a stand-alone study.
While stand-alone LTFU studies are not new, the models have evolved with the advent of potentially transformative therapies and treatments, including, but not limited to advanced therapy medical products, cellular products and gene therapies. Sponsors are showing more interest in this specific type of study given new regulatory requirements, which in some cases call for 15 years of monitoring of patient outcomes and safety.
Register for this webinar to explore:
- Various models of LTFU studies and their applications
- Operational considerations to streamline the transition from clinical research to commercialization in the current regulatory environment
Join experts from ICON, Brandon Fletcher, Cell and Gene Therapy Principal; and M. Christina Haas, Director, Project Management, Real World Evidence Late Phase Research, for the live webinar on Monday, July 19, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Designing and Conducting Effective Long-term Follow-Up Studies.
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