In the August issue of New England Journal of Medicine (NEJM), Dr. Ethan Basch, an oncologist at Memorial Sloan-Kettering Cancer Center wrote an article titled Toward Patient-Centered Drug Development in Oncology. Dr. Basch pointed out there is a lack of patient perspective in oncology drug development—when asked about symptom information of a treatment by patients, oncologists are often not able to provide it because such information is not included in the FDA-approved label. Dr. Basch noted that information about patient experience, if ever gathered in a pivotal clinical trial, is mainly through questionnaires focused on health-related quality of life rather than being included in the protocol-specified hypotheses and analytic or statistical plans. However, things might soon change– the FDA recently issued guidance on the use of patient-reported outcomes (PROs) in drug development, which may encourage the pharmaceutical industry to include the measurement of PROs in future drug development.
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