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Cancer Drug Endpoints: More Standardization Needed In ctDNA Assessments, US FDA Says

 
• By Sue Sutter

Circulating tumor DNA needs to be prospectively incorporated into trials to assess whether it correlates with long-term outcomes. More standardization in assays and when the biomarker is measured would strengthen analyses of data across studies, FDA officials said.

Boats at dock
More standardization of circulating tumor DNA assessments has the potential to raise all boats in cancer drug development. • Source: Shutterstock

With work ongoing in the oncology community to develop the evidence needed to support circulating tumor DNA as a regulatory efficacy endpoint, one US Food and Drug Administration official is making a plea for standardization.

Developing the evidence needed to support use of a novel endpoint is a “heavy lift” requiring many stakeholders and pooling data across numerous trials for meta-analyses purposes, the Oncology Center...

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