From Nature Medicine. Published online 7 January 2011.
In the last decade, the world’s drug regulatory agencies have approved dozens of new anticancer therapies for everything from lung carcinoma to skin melanoma. Some of these new drugs add months to a patient’s life. But others may offer only an extra week or two, on average, often with considerable toxicity and at a cost of thousands of dollars.
Now experts are questioning whether these outcomes provide meaningful benefit to people’s quality of life and are urging regulatory agencies to toughen the criteria for drug approval. Such a measure would push pharmaceutical companies to modify the design of clinical trials—a move that some drug makers and doctors worry could shrink the drug market.
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