1. Driven to service whose needs?
On clinical trials as marketing instruments
Trudy Dehue, professor of
Theory and History of Science
1
2. RCT
Randomised clinical trial
Randomly
composed
Experimental Test
group(s)
Control Test
group
2
3. Randomised clinical trial (RCT)
Phase I: small group of subjects; safety check.
Phase II: larger group of subjects; test for intended e
and side-effects
Phase III: repeat phase II with a larger group of
subjects.
Phase IV: post- (or peri-) marketing research;
control for effects and safety in various populations a
with long-term use.
3
4. Good, P. (2006)
A manager’s guide
to the design and
conduct of clinical
trials.
4
10. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
10
11. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
11
16. Richard Smith Fiona Godlee (2008)
(2005) ‘The evidence that
‘Medical journals industry funding
are an extension of biases the design
the marketing arm and reporting of
of pharmaceutical clinical research is
companies’ overwhelming’
17. “It is simply no longer possible to believe much
of the clinical research that is published, or to
rely on the judgment of trusted physicians or
authoritative medical guidelines” (Marcia Angell,
former editor of The New England Journal of
Medicine in The New York Review of Books,
2009).
18. BMJ, 8 December 2009
"The current system isn’t working. Worse than that, it gives
18
a false sense of security"
19. Food and Drug Administration
College ter Beoordeling van Geneesmiddelen
19
21. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
21
22. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
22
39. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
39
40. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
40
43. January 17 2008 Volume 358:252-260 Number 3
Selective Publication of Antidepressant Trials
and Its Influence on Apparent Efficacy
Erick H. Turner, M.D., Annette M. Matthews, M.D.,
Eftihia Linardatos, B.S., Robert A. Tell, L.C.S.W.,
and Robert Rosenthal, Ph.D.
43
44. Article handed out by Janssen-Cilag at
2010 international psychiatry conference.
Research sponsored by Janssen-Cilag.
44
45. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
45
46. When researchers are driven to service
companies’ needs
-trials become demonstrations
-research becomes marketing
-articles become advertisements
-authors become authorities
46
47. Bleidt & Montagne (1997),
p.251-252
‘The direction provided by
marketing is crucial to designing
trials (...)’
47
48. Bleidt & Montagne (1997),
p.254
on ‘pre-approval marketing
activities’:
‘This goal is accomplished
through presentation of clinical
information at scientific
meetings, using posters and
other exhibits, and the
publication of articles in
scientific journals’.
48
49. Social Studies of Science, 2004, 34, 187-218
On clinical trial researchers
acting as mediators between
producers and consumers
49
54. BMJ, 4 april 2009, vol 388, p. 804-807
54
www.esf.org/fileadmin/links/EMRC/FL_IDCT.pdf
55. Recommendation
CROs should be driven to service the
needs of civilians rather than
pharmaceutical companies.
Hence, financially independent agencies
should act as an interface between clinical
trialists and pharmaceutical companies.
55
56. Driven to service whose needs?
On clinical trials as the population’s instruments
Trudy Dehue, professor of
Theory and History of Science
56
