It is inappropriate for those decisions to be made purely on marketing reasons, but it is the way it goes.

The company researchers and executives approach marketing to determine who, what, where and when a drug will fit in the market and how will it generate the best ROI for the organization. Whatever market research is discovered goes into the marketing mix, and marketing then influences the direction of the clinical research.

It is quite crazy when you think that Medical doctors and researchers who have dedicated years to their education and perfecting their skills are actually being “undermined” and in some cases compromised by the decisions being made in the marketing department. Some marketing directors have MBA’s some do not. Medical, regulatory should drive the process. When I was working in Pharma, I insisted and usually got what I wanted, because it worked. We increased our credibility with our KOL’s who then found ways to give us more time, this worked to our competitive advantage.

Big Pharma does have some very good people working inside, very smart PhD and MD’s, they need to listen to these people much more than just thinking about the marketing, that is what is killing them and causing the problems and great distrust.

Hope the right people read this and think about thinking out side of the box for a change….

Journal of Vascular Surgery

THE PROBLEM
Research contracts between a company and a clinical
trial investigator often contain “non-disclosure” clauses,
drawn up to protect the company against the investigator
divulging proprietary information or information about the
company’s business operations. Yet the research contracts
that today’s investigators are asked to sign before partici-
pating in an industry-supported clinical research trial often
contain broadly worded clauses that can be used to restrict
their rights to access, analyze, and report trial data. Typi-
cally, they demand confidentiality by restricting the dissem-
ination of “confidential information,” but in doing so may,
for example, include in the definition of confidential infor-
mation “data developed or generated in whole or part by
the investigator during the research investigation.” Some
clauses prohibit “publication of the results of the research
unless agreed to by the Company in writing.” The latter
restriction may be either without time limits or allowed
under contract only after an inappropriately long period of
time after completion of the research or trial. Such clauses
can create and have created problems for investigators,
probably only a small portion of which has been reported by
summaries and statistical analyses performed by the com-
pany. There may be a lack of investigator input into the data
included in or excluded from the summary data set and thus
from publication, with no recourse under the terms of the
contract. Delays or failure to report adverse events or to
report negative trials may result, and the company’s role in
causing these may be justified or defended by the restrictive
terms of many contracts.
Tactics that have been reported as delaying or discour-
aging publication of negative or unfavorable clinical re-
search trials include withholding company approval of a
manuscript submission (based on terms stipulated in the
contract) and dragging out the company review of the
manuscript (which is required by contract), prolonging a
dispute over company-suggested revisions and/or having
another version submitted by other authors in the interim.6
Companies have also withheld raw data needed as back-
ground for a published report.2,10 Other tactics have been
reported, not necessarily based on contract restrictions.10
Such tactics may include requesting investigators/authors
to withhold publication of the trial data until after an
additional ….

THE PROBLEM
Research contracts between a company and a clinical
trial investigator often contain “non-disclosure” clauses,
drawn up to protect the company against the investigator
divulging proprietary information or information about the
company’s business operations. Yet the research contracts
that today’s investigators are asked to sign before partici-
pating in an industry-supported clinical research trial often
contain broadly worded clauses that can be used to restrict
their rights to access, analyze, and report trial data. Typi-
cally, they demand confidentiality by restricting the dissem-
ination of “confidential information,” but in doing so may,
for example, include in the definition of confidential infor-
mation “data developed or generated in whole or part by
the investigator during the research investigation.” Some
clauses prohibit “publication of the results of the research
unless agreed to by the Company in writing.” The latter
restriction may be either without time limits or allowed
under contract only after an inappropriately long period of
time after completion of the research or trial. Such clausessummaries and statistical analyses performed by the com-
pany. There may be a lack of investigator input into the data
included in or excluded from the summary data set and thus
from publication, with no recourse under the terms of the
contract. Delays or failure to report adverse events or to
report negative trials may result, and the company’s role in
causing these may be justified or defended by the restrictive
terms of many contracts.
Tactics that have been reported as delaying or discour-
aging publication of negative or unfavorable clinical re-
search trials include withholding company approval of a
manuscript submission (based on terms stipulated in the
contract) and dragging out the company review of the
manuscript (which is required by contract), prolonging a
dispute over company-suggested revisions and/or having
another version submitted by other authors in the interim.6
Companies have also withheld raw data needed as back-
ground for a published report.2,10 Other tactics have been
reported, not necessarily based on contract restrictions.10

In many cases now, the P.I.’s do not always get access to this data, they get access only to the trial data from their site, which provides an incomplete picture if it is a multiple trial site.

Excerpt from recent paper with source sited below….

THE PROBLEM
Research contracts between a company and a clinical
trial investigator often contain “non-disclosure” clauses,
drawn up to protect the company against the investigator
divulging proprietary information or information about the
company’s business operations. Yet the research contracts
that today’s investigators are asked to sign before partici-
pating in an industry-supported clinical research trial often
contain broadly worded clauses that can be used to restrict
their rights to access, analyze, and report trial data. Typi-
cally, they demand confidentiality by restricting the dissem-
ination of “confidential information,” but in doing so may,
for example, include in the definition of confidential infor-
mation “data developed or generated in whole or part by
the investigator during the research investigation.” Some
clauses prohibit “publication of the results of the research
unless agreed to by the Company in writing.” The latter
restriction may be either without time limits or allowed
under contract only after an inappropriately long period of
time after completion of the research or trial. Such clausessummaries and statistical analyses performed by the com-
pany. There may be a lack of investigator input into the data
included in or excluded from the summary data set and thus
from publication, with no recourse under the terms of the
contract. Delays or failure to report adverse events or to
report negative trials may result, and the company’s role in
causing these may be justified or defended by the restrictive
terms of many contracts.
Tactics that have been reported as delaying or discour-
aging publication of negative or unfavorable clinical re-
search trials include withholding company approval of a
manuscript submission (based on terms stipulated in the
contract) and dragging out the company review of the
manuscript (which is required by contract), prolonging a
dispute over company-suggested revisions and/or having
another version submitted by other authors in the interim.6
Companies have also withheld raw data needed as back-
ground for a published report……2,10 Other tactics have been
reported, not necessarily based on contract restrictions.10
From the Department of Surgery, Vascular Surgery Section, University of Colorado Health Sciences Center,a and the Department of Surgery,
Toronto General Hospital, University of Toronto.b
Reprint requests: K. Wayne Johnston, MD, Editorial Office, Toronto General Hospital, 5 Eaton, Room 312, 200 Elizabeth St, Toronto, Ontario,
M5G 2C4, Canada.
J Vasc Surg 2002;35:1036-40.
Copyright © 2002 by The Society for Vascular Surgery and The American
Association for Vascular Surgery.
0741-5214/2002/$35.00