Designing and Conducting Effective Long-term Follow-Up Studies

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 commercialisation in the current regulatory environment

Speakers

Brandon Fletcher, Cell and Gene Therapy Principal, ICON

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 organization.

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M. Christina Haas, Director, Project Management, Real World Evidence Late Phase Research, ICON

Chris joined ICON in 2004 and is field-based near Munich, Germany and has held the position of Director, Project Management, Real World Evidence Late Phase Research, since 2013. Chris is responsible for providing Project Director oversight and governance to teams that manage, organize, 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.

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