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

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.

Read the full 1498 word article

User Sign In

Article Purchase

This article may not be distributed to non-subscribers

PURCHASE THIS ARTICLE FOR LIMITED ONE-TIME DISTRIBUTION AND WEBSITE POSTING $995.00 USD

PURCHASE