6:26 AM
May 17, 2019
 |  BioCentury  |  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

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. Ltd. presented details at the International Symposium on Myelodysplastic Syndromes (MDS) in Copenhagen on a PRO to assess fatigue in MDS, chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML).

Rather than start from a clean slate, as is usually the case, the pharma created the PRO by building onto the Quality of Life Questionnaire-Core 30 (QLQ-C30) from the European Organisation for Research and Treatment of Cancer (EORTC).

Takeda reported that in a fit-for-purpose analysis in patients with MDS, CMML and AML, the PRO showed better reliability and better coverage of the aspects of fatigue that were important to patients than the EORTC tool alone. The results support the use of this modified PRO as a tool that can be used to assess fatigue in patients with hematologic malignancies.

“We showed that you can be flexible and innovative with your patient reported outcome strategies without having to develop a...

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