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

[Joseph DiMasi]

Mike,

I have been down this road on clinical trial sizes before with Jamie.
First of all, the results from the study refer to a particular period in
the past, not 2004.  Second, and more important, the numbers that you
pull out of labels or reviewer summary documents posted on the web need
not come anywhere close to the number of subjects actually studied prior
to a U.S. approval.  The FDA labels and documents will often just note
what the reviewers considered to be trials that were pivotal to  the
indication that was approved (i.e., often a few relevant phase III
trials).  You cannot assume that what you pick out of these sources
represents the entirety of clinical testing.  Third, we noted in our
study data gathered independently by PAREXEL and reported for various
years in their compendium of pharmaceutical industry R&D statistics that
had a mean of 5,621 for a period  relevant to our study.

Joe DiMasi



Mike Palmedo wrote:

> http://www.cptech.org/blogs/drugdevelopment/2006/07/bayh-dole-rights-size=
-of-clinical.html
>
>
> Bayh Dole Rights, Size of Clinical Trials, 2004 Approvals
>
> July 10, 2006
> Mike Palmedo
>
> CPTech has looked at the patents for New Molecular Entities (NMEs) that
> came to the market in 2004.
>
> Excluding antibiotics, which do not have Bayh-Dole listings in their
> patents, the FDA approved 19 NMEs in 2004. Nine of these received
> priority status for approval, meaning they were found to have
> significant therapeutic gain over existing medicines. The remaining 10
> NMEs were given standard approvals.
>
> For the products for which data was available, I looked up the number of
> patients cited by the FDA in approving the medicines. (I had to exclude
> three of the priority NMEs approved in 2004 for which the label did not
> include the number of patients) The average (mean) number of patients in
> the clinical trials on which the FDA approvals were based was 1073 for
> priority drugs and 1840 for standard drugs. The median numbers of
> patients in these clinical trials were 1290 for the priority drugs and
> 2058 for the standard drugs. These figures are considerably lower than
> the average size of clinical trials used by DiMasi in his often-cited
> research on the cost of drug development =96 5,303 patients.
>
> The Orange Book lists 45 patents on the 19 NMEs. Three of these patents
> include clauses citing government funding and subsequent Bayh-Dole
> rights to use or license the patent. These three patents cover two of
> the nine drugs which received priority approval =96 two patents for Clola=
r
> (a leukemia drug sold by Genzyme) and one for Lyrica (a diabetes drug
> sold by Pfizer).
>
> A spreadsheet with the drugs, patents, and size of trials is online here:
> http://www.cptech.org/ip/health/rnd/2004nmes-07102006.xls
>
> [Posted by Mike Palmedo to Drug Development (with access) at 7/10/2006
> 03:59:00 PM]
>
>
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--
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Joseph A. DiMasi, Ph.D.
Director of Economic Analysis
Tufts Center for the Study of Drug Development
Tufts University
192 South Street, Suite 550
Boston, MA 02111
tel: 617-636-2116; fax: 617-636-2425
URL: http://csdd.tufts.edu
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