[Ip-health] Bayh Dole Rights, Size of Clinical Trials, 2004 Approvals

[James Love]

On Jul 13, 2006, at 8:53 PM, Joel Lexchin wrote:

> For those of us watching this debate with great interest could someone
> explain what PAREXEL is and where it gets its data, i.e., how
> reliable are
> the figures that it reports.
>

When I last looked at it (it is now priced at $425 for the annual
publication), it was a useful place to see the results of all sorts
of data collected on R&D from all sorts of people, including a number
of studies that were quite different from the TUFTS studies (such as
the Pharmaceutical Education and Research Institute [PERI] study of
117 development projects at 20 pharma firms, which estimated average
outlays of $74 million on successful projects (Project Management in
Pharmaceutical Industry: A survey of Perceived Success Factors 1995-1996
. PERI), numbers more closely aligned by the TB Alliance estimates.
(These are not adjusted for risk)   When I looked at the estimates of
the size of trials on FDA approval drugs, the averages were similar
to Joe's, but the samples also looked pretty incomplete.    For
example 1998 (17 of 30 approvals, with 7 of 13 excluded were orphan
drugs), 1999 (19 of 35), 2000 (16 to 27), 2001 (12 of 24).   I
haven't looked at the more recent data.  Here too it is interesting
to look at the ranges reported by Parexel --  in 2000, from 1,345 to
35,696.  In 1999, from 202 to 14,300.   So small changes in the same
make a big difference.  In 2000, the inclusion of a single drug
(Mobic) raised the 16 sample mean by 1,936.   (For 3 of the 4 years,
the median was significantly below the mean).  We will try to get the
relevant info from Parexel to compare their estimates, drug by drug,
with those from the FDA approval letters.    Jamie

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