BioCentury
ARTICLE | Product Development

Takeda shaves years off PRO development, brings patient voice to fatigue measures in cancer

How Takeda built a PRO for fatigue in blood cancers without reinventing the wheel

May 17, 2019 1:26 PM UTC

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”)...