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www.fdanews.com/articles/142742-woodcock-submit-pro-measures-early-use-to-check-quality-of-life

Woodcock: Submit PRO Measures Early, Use to Check Quality of Life

December 27, 2011
Drug trial sponsors developing patient-reported outcome (PRO) measures should seek FDA qualification for those tools prior to clinical trials and should use them to gauge quality of life, CDER Director Janet Woodcock advises.
Clinical Trials Advisor