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FDA may push cancer drugmakers to include QoL data

Three decades after oncology researchers called for further examination of how cancer treatments affect quality of life, only 14% of the 214 cancer drug indications approved by the FDA from 2006 through 2017 included QoL data, but by October 2019, QoL data from registration trials was available for 40% of the therapies. Drugmakers lack incentive to calculate and report QoL data because the FDA does not mandate it, said lead author Dr. Kelvin Chan, but the agency is developing guidance for patient-centered drug development.

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