E-DRUG: Publication on outsourcing clinical trials
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Dear all,
I would like to draw your attention to a recent publication by SOMO,
Salud y Farmacos and CSER titled 'Putting Contract Research
Organisations on the Radar. An exploratory study on the outsourcing of
clinical trials by pharmaceutical companies to contract research
organisations in non-traditional trial regions.' Introduction to the report:
It is a trend for pharmaceutical companies to contract third parties to
conduct their clinical trials in order to test their drugs. This trend
is referred to as 'outsourcing', and the companies that carry out the
work are called 'contract research organisations' (CROs). In addition,
clinical trials are increasingly conducted in non-traditional trial
regions, which are mainly low- and middleincome countries. This trend is
called 'offshoring'. It is widely agreed that the offshoring of clinical
trials to these regions should be scrutinised from an ethical
perspective because of the vulnerability of the trial population. What
happens when offshoring is combined with outsourcing? Do additional
ethical risks arise when clinical trials are contracted out? Virtually
all pharmaceutical companies publicly declare that they test their drugs
in accordance with the highest ethical guidelines, such as the
Declaration of Helsinki. But how do pharmaceutical companies safeguard
their commitments when they outsource clinical trial activities to CROs
in poor regions? These are the central questions that are addressed in
this report.
The report is based on research conducted in India , Argentina , Brazil
and Peru , and combined with interviews with pharmaceutical companies
and clinical trial experts. The research experiences demonstrate that
the pharmaceutical sector is generally not transparent, which hinders
the definitive answering of the research questions. Nevertheless, the
secondary and interview data collected in India , Argentina , Brazil and
Peru provides some valuable insights into the way the CRO sector is
developing in these countries. Furthermore, the report demonstrates that
pharmaceutical companies have elaborate systems in place to manage their
supply chain responsibility, although their functioning can not be
independently verified. In addition, experts, authorities and clinical
trial practitioners in the selected non-traditional trial regions still
expressed grave concerns about the implementation of clinical trials in
these countries.
The report can be downloaded here:
http://somo.nl/publications-en/Publication_3615
Stichting Onderzoek Multinationale Ondernemingen (SOMO)
Centre for Research on Multinational Corporations
Mariëtte van Huijstee
Researcher
Sarphatistraat 30
1018 GL Amsterdam
The Netherlands
T: +31 (0)20 6391291
F: +31 (0)20 6391321
Website: www.somo.nl <http://www.somo.nl/>
m.van.huijstee@somo.nl