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.