ASCO defines meaningful

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The American Society for Clinical Oncology is putting a definition to the FDA's term “clinically meaningful outcome.” BioCentury reports that the professional organization published its recommendations in the Journal of Clinical Oncology and developed guidelines for what constitutes "meaningful" in trials for pancreatic, breast, lung and colon cancers.

The group used overall survival as the primary endpoint and recommended a benchmark, such as establishing a period of 4 to 6 months, as the minimum median OS improvement for untreated, metastatic, triple-negative breast cancer.

The group also said the experimental treatments should not include a higher toxicity than current treatments.

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