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I know that people have bantered about that clinical trials have about a 50%
failure rate. Does anyone have an actual reference on this number? Thanks.
PETER L. BONATE, PhD.
Clinical Pharmacokinetics
Quintiles
POB 9708 (L4-M2828)
Kansas City, MO 64134
phone: 816-767-6084
fax: 816-767-3602
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Pete,
What do you mean by a "50% failure rate"? Are you referring to evaluability or
clinical outcome? If the latter, then this is a nonsense number. If the
former, I'm sure it
To continue...
it depends on the drug and the indication being sought. For antibiotics, for
respiratory tract infections, it might be reasonable as only about 50-60% are
microbiologically evaluable. For uncomplicated UTI, the non-evaluability rate
would be much lower.
George Drusano
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Peter (et al),
The first person I heard that from was Carl Peck. I believe it came from
a fairly informal survey of medical reviewers at FDA, and is pretty old.
Carl may have more recent and or rigorous data since then, I think it is
fairly old.
Mark
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Peter, Mark
I recently asked Carl about this survey and, assuming we are
talking about the same thing, it was published in: Food and
Drug Law Journal 1997;52:163-167. This paper describes a
CDDS study of new drug applications to the FDA.
Regards
Steve
=====================
Stephen Duffull
School of Pharmacy
University of Manchester
Manchester, M13 9PL, UK
Ph +44 161 275 2355
Fax +44 161 275 2396
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