Do Clinical Trials Work?

“Do Clinical Trials Work?” The New York Times on Jul. 13, 2013.

EVERY spring, some 30,000 oncologists, medical researchers and marketers gather in an American city to showcase the latest advances in cancer treatment. But at the annual meeting of the American Society of Clinical Oncology last month, much of the buzz surrounded a study that was anything but a breakthrough. Dr. Gilbert’s study found no difference in survival between those who were given Avastin and those who were given a placebo.

As far as clinical trials went, Dr. Gilbert’s study was the gold standard.  more than 600 brain cancer patients were randomly assigned to two evenly balanced groups: an intervention arm (those who got Avastin along with a standard treatment) and a control arm (those who got the latter and a placebo). What’s more, the study was “double-blind” — neither the patients nor the doctors knew who was in which group until after the results had been assessed. But even after some 400 completed clinical trials in various cancers, it’s not clear why Avastin works (or doesn’t work) in any single patient. That we could be this uncertain about any medicine with $6 billion in annual global sales — and after 16 years of human trials involving tens of thousands of patients — is remarkable in itself. And yet this is the norm, not the exception.

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