E-drug: Maintaining the integrity of the clinical evidence base (2)
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With regard to the recently reported editorial in the WHO Bulletin,
Maintaining the integrity of the clinical evidence base by Jonathon
Quick, I would like to make the following comments:
1. Financial conflicts of interest is a topic of interest to all of us, but
fraught with bias, regardless of observations made. Here is an
example that speaks to such concerns. No mention here regarding
agreements that might encourage publication by authors who, in
fact, do favour one or another therapy. A troublesome conclusion,
maybe. Also, independently funded pharmacoeconomic studies
more often than not will occur for no other reason than
manufacturers choose not to pursue similar comparative studies,
regardless of reasons underlying such decisions. Again, a
troublesome area, filled with conjecture, for purposes of discussion.
2. It is important to remember the necessity of going to the source of
the concern, problem, issue, and dealing with that finding. In the
editorial, we have complaints in the form of observations about
clinical data, and its manipulation. Quite clearly, none of these
complaints/observations should continue to be perpetuated, without
acknowledging the solution. Let me illustrate it this way.
Clinical research is conducted and managed through the collection
of patient data, either through the use of a "paper-driven" system,
with forms that investigators fill out following a specific study
protocol, or through the use of "automated clinical data collection"
system, with patient data entered onto a computer application.
If you remember, there was a time, in the late 1960's, when the U.S.
was sending its first "shuttle" to the moon. In order to do that, data
had to be entered, algorithms carried out, and decisions made in
fractions of a second. The premise was, that with reliable and
accurate data, decision-making becomes quite straightforward.
That enabling technology never disappeared, and is present, today.
In fact, this is non-proprietary programming/software, that enables
control of information at the Input/Output level, keystroke level, if-
you-will, that ensures the reliability and integrity of clinical research
data, in "real-time" mode. Further, the ability to capture and
playback, keystroke-by-keystroke, visually, makes it an attractive
candidate for establishing Electronic Oversight of all clinical
research by regulatory authorities as the clinical protocols are
carried out without geographic restrictions. Under such a system,
all other issues surrounding the accuracy and reliability of clinical
research data is either eliminated, or significantly reduced, as
issues.
With such a solution in front of us, this begs the question, why do
we continue to permit the present "institution" to continue killing
people needlessly, in the name of profits?
3. The editorial claims that most clinical research is still conducted
to highly exacting standards of objectivity. I would like to see some
expansion and support for that proclamation!
4. With regards the WHO tightening its rules for staff and expert
advisers on conflicts of interest, as stated above, I believe we, and
the WHO, would be better served to address the singular issue of
ensuring reliable and accurate clinical research data collection, first,
then look to see what issues surrounding are in need of our
collective assistance.
5. Many of the issues identified in the editorial can be easily
accomplished, and quite surprisingly, offers a win-win situation for
everyone:
Manufacturers reduce R&D costs by some 70%
Manufacturers enter a "controlled market place" years earlier
than otherwise
Patent exclusivity lengthens some 10 years or more
Prices drop significantly
Manufacturers realize larger profit margins
Thomas A. Poe, M.D.
Director
The World Centre for Clinical Research
http://www.worldccr.org/
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