Memorial Sloan-Kettering Cancer Center

Patient safety reporting and drug label accuracy missing vital information

Published in Medical Letter on the CDC and FDA, March 28th, 2010

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

Ethan Basch, MD, outcomes researcher and medical oncologist at Memorial Sloan-Kettering Cancer Center, recommends that fundamental change is necessary in order to improve the process of evaluating the true toxicity of drugs. Dr. Basch has found that clinicians - the current responsible party for collecting and reporting symptoms in clinical trials - systematically miss...

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Source: Medical Letter on the CDC and FDA (2010-03-28)

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