BioCentury
ARTICLE | Politics & Policy

Agency reps recommend patient-reported outcomes for regulatory decision making

May 10, 2018 9:19 PM UTC

In a policy review published in The Lancet Oncology, authors from international regulatory agencies recommend incorporating patient-reported outcomes (PRO) into regulatory decision making.

The paper's authors include Paul Kluetz from FDA's Oncology Center of Excellence; Daniel O’Connor from U.K.'s Medicines and Healthcare Products Regulatory Agency; and Katherine Soltys from Health Canada's Therapeutic Products Directorate, Health Products and Food Branch...