As far as "scary mistakes" go, I think there is plenty of evidence that
scary mistakes were made before the advent of RCTs and that scary mistakes
are made in the absence of RCTs, even today.
Couldn't agree more. Witness the FDA approval of flecainide prior to the
CAST trial. Let's hope the FDA has got better at requiring RCT evidence
befrore approving drugs for use. But even worse perhaps are the "scary
mistakes" made in the presence of RCTs. Witness the whole DES debacle.
Andrew Jull
HRC Foxley Fellow
Clinical Trials Research Unit
University of Auckland
New Zealand
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