New regulatory requirements have sparked more interest in stand-alone long-term follow up studies for monitoring patient outcomes and safety.
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.
Join us as we explore:
- Various models of LTFU studies and their applications
- Operational considerations to streamline the transition from clinical research to commercialisation in the current regulatory environment
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Brandon is a Biochemist and Cancer Immunologist with roughly 30 years of research experience, specializing in hematology-oncology, rare disease and infectious disease. She has held roles in broad immune-oncology and cell and gene therapy research within academia and industry. Brandon is a collaborator with NCI’s origination of cancer CGTs and co-founded a global immune-oncology research training and support organisation.
Christina joined ICON in 2004 and has held the position of Director, Project Management, Real World Evidence Late Phase Research, since 2013. Christina is responsible for providing Project Director oversight and governance to teams that manage, organise, and implement global late phase projects; overseeing managers that lead multidisciplinary cross-functional project teams from study start-up through to final product deliverable; and facilitating communications with clients. She has more than 24 years of experience in clinical research (phases II-IV) in both interventional and non-interventional studies on a global scale.
Audience
This program will be beneficial for pharmaceutical, medical device, and biotechnology professionals working in the following areas:
- Clinical research
- Clinical development
- Patient outcomes
- Real world evidence
- Cell and gene therapies