Saturday, August 15, 2009

Pharma Sponsored Clinical Trials Agreements, Reconsidered. . . .

This is Part Two, to this companion piece, of yesterday. It deals with more weedy details -- in the hope of avoiding "the next iceberg" -- the next highly-orchestrated early-release of partial top-line studies data, a la the July 2008 SEAS-style press event. So to get right to it, then:

In many clinical trials agreement forms signed prior to 2006 (such as the one likely signed by Duke, Dr. Califf and Merck-Schering-Plough), the corporate sponsor may hold great sway over what happens with data from a given study. In fact, in many of these older agreements, the corporate sponsor (referred to as "Pharma Co.", below) may own the data, outright.

It is then possible, that under the IMPROVE-IT clincial trial acreement, Dr. Califf (and by extension, Duke University) possessed no right to "say no" to Merck/Schering-Plough's interim use of the data -- even if all Merck and Schering-Plough wanted the early access to study data for was to butress a claim that the cancer signal data in SEAS was spurious. In other words, even if Schering-Plough solely sought the data for PR or Investor Relations purposes.

To be clear, safety should always be paramount, but assuming Dr. Califf was adequately monitoring his IMPROVE-IT patient-data-sets for cancer signals (and we have no reason to suspect he wasn't) -- then he was, in some fashion, made an unwitting shill, at the July 21, 2008 SEAS (highly orchestrated) press event, primarily because his clinical trial agreement did not afford him enough independence from (Pharma Co.) sponsor-influence. Here is a typical version of the relevant older, pro-sponsor contract clause:


Pharma Co. shall exclusively own all rights, title and interests (collectively "Rights") in and to any inventions, data (including Study results and any clinical specimens or samples obtained from Subjects), discoveries, know-how, patents, copyrights, moral rights, trade and service marks, and trade secrets and other intellectual property, including but not limited to inventions, discoveries and technology relating to the Investigational New Drug or otherwise generated by the Study (collectively, the "Discoveries"). The Study Center and the Researchers hereby irrevocably transfer and assign any and all their Rights in any such Discoveries to Pharma Co.. The Discoveries will be the sole property of Pharma Co. and Pharma Co. will have the right to determine the treatment of any Discoveries, including the right to keep them as trade secrets, to file and execute patent applications on it, to use and disclose it without prior patent application, to file copyright and trademark applications on it or its own name, or to follow any other procedure Pharma Co. deems appropriate. . . .

Note also that the above clause would allow the Pharma Co. permanently to prevent publication of a null result, for example. All the Pharma Co. need say was that all data comprised "trade secrets", and was thus immune from publication (and any other disclosure) by the university or the Principal Investigator(s).

Some other time, I will outline a more modern, and independent version of these sorts of clinical trial agreement clauses, but upon reflection, this clause (in part) could have contributed significantly to Dr. Califf's feeling "forced" (by Merck and Schering-Plough) to disclose (at least three years' prematurely) the top-line IMPROVE-IT trial data, perhaps even directly to agents of M/SP, rather than an ad hoc committee of his PI peers, in strict-confidence. Such a strictly confidential "PIs only" disclosure could have been conditioned upon a covenant preventing M/SP from using it for [remature PR purposes.

I may post more on this, if readers' interest, or developments, warrant.

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