Reporting on the long-term safety of patients who receive cell and gene therapies remains vitally important to regulators, as demonstrated by recent U.S. Food and Drug Administration (FDA) guidance in this area. Similarly, the need to follow up with patients across a range of therapy areas including oncology, rare diseases and chronic conditions to understand long-term survival, safety, quality of life and other parameters is essential, but poses challenges for investigators, sites, patients and sponsors.
In this white paper, our experts discuss a number of practical strategies for minimizing the burden on all stakeholders involved in these studies. We also describe how the use of a proprietary platform approach to operationalize LTFU studies provides cost and operational efficiencies, increases patient retention and enables integrated data insights.
