CANCER DIGEST – Oct. 4, 2017 – That’s the question a group of British researchers at King’s College in London asked for a study published today in the British Medical Journal (BMJ).The study looked at the clinical data for cancer drugs approved by the European Medicines Agency, the European version of the US FDA, between 2009 and 2013. They found that of the 68 drugs approved during that period, 39 (57%) were approved on the basis of surrogate endpoints. This is essentially an endpoint that is substituted for an actual outcome. This is done to speed approvals of certain drugs.
For example, instead of waiting to see how many people given a drug actually survive 5 years, scientists know from past research that given the percentage of patients who achieve complete remission in the first year, a percentage of those will survive 5 years.
What the Kings College researchers found, however, was that of the 39 drugs approved in this manner, only 8 eventually showed a survival or quality of life improvement compared to existing drugs or placebo after five years of follow-up.
In a related editorial, Vinay Prasad, assistant professor at Oregon Health & Science University in Portland, OR, said, "The expense and toxicity of cancer drugs means we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life. These findings suggest we may be falling far short of this important benchmark.”
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