Using ctDNA as an endpoint in your cancer clinical trial? FDA wants to hear from you

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Circulating tumor DNA has the potential to not only change the way medical oncologists assess and treat cancer patients, but also how cancer drugs are reviewed, oncology experts at FDA and pharmaceutical companies said in response to research findings published July 11 by a collaboration led by Friends of Cancer Research.

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Matthew Bin Han Ong
Matthew Bin Han Ong
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Friends of Cancer Research characterized postmarketing requirements and commitments over the last decade. The perspective article, titled “An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials,” provides insights into FDA’s expectations for representation of race and ethnicity in oncology clinical trials.
Matthew Bin Han Ong
Matthew Bin Han Ong

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