how much do phase 3 clinical trials for ischemic stroke cost?

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Request for Question Clarification by crabcakes-ga on 03 May 2006 17:44 PDT

This would depend on the number of cohorts, the drugs/therapies being
tested, lab/imaging studies needed, etc. One simply can't give a
blanket cost.

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Clarification of Question by biotechie-ga on 04 May 2006 06:53 PDT

Well, I'm looking for a rough range. Genentech's got tPA.  AstraZeneca
has Cerovive.  If possible I'd like someone to give me a range using
let's say five phase III ischemic stroke trials.  I'd prefer the range
to be an estimate for neuroprotectors rather than thrombolytics, but
if using thrombolytic stroke trials helps create a range, then that's
fine.  Cerovive's the most important benchmark, though, and I'd love
to see the costs for a few others of similar type.

Thanks.

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Clarification of Question by biotechie-ga on 06 May 2006 23:05 PDT

ok -- let's try another clarification.  Find me the costs from three
sets of Phase III stroke trials i the past five years:  Cerovive,
genentech's tPA, and any one other phase 3 ischemic stroke trial.

$20-25M.

Stroke trials are considered very complex because of the acute nature
of the disease.  Recruitment is slow, generally < 0.5
patients/site/month even at the well-known stroke centers.  Unlike
chronic diseases, here you must "wait" for patients to have their
stroke, cross your fingers that they recognize it's a stroke quickly,
find their way to the site you contracted to include in your study,
have the ER doc confirm it is a stroke and which type, and recognize
that there is a trial ongoing to include the patient.  Generally, this
all has to happen in less than 12 hours (even shorter for some
therapies).  While the follow-up period is limited (~3-6 months for
following functional improvement and for stroke recurrence) they can
be diagnostic-heavy (involving both conventional and novel types of
imaging).  Several major stroke trials in the past 7 years enrolled
1,000+ patients and included sites in over 30 countries -- all just to
find that their drug failed to demonstrate efficacy.  Sadly, even tPA
(considered effective) has limited applications due to the challenges
of identifying pateints quickly (as described above).