Takeda has sidestepped the FDA qualification process for patient-reported outcomes by building on validated tools to develop a PRO for fatigue in hematologic malignancies. The approach enabled the pharma to cut its PRO development time in half, and should help it get a head start on future PROs.
PRO measures are the most direct way to assess how patients experience the benefit or harm of a therapy. However, it can take nearly a decade to develop, validate and approve a PRO through FDA's qualification pathway for use as a primary or secondary endpoint in a clinical trial, or for inclusion on a drug's label (see “PRO Progress”).
While FDA started last year to encourage companies to take a modular approach and modify existing tools, providing a much shorter path to PROs, Takeda seized on the idea well before that, starting its process in 2016.
On May 8, Takeda Pharmaceuticals Co.