New
Zealands population of four million is comprised
predominantly of citizens from European, Asian and
Polynesian descent with most living within close
proximity of one of eight metropolitan areas where the
majority of clinical research is conducted.
Over
the years, NZ research sites have consistently
matched or outperformed (patients / site) many
of their International peers without
sacrificing quality. Well developed
professional networks are in place to allow a
given sponsor exposure to an increased patient
base.
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The population spread means that in
several regions that are successful in
conducting clinical research there is one
primary hospital. As an example, Waikato and
Canterbury provinces each have catchments of
>400,000 patients who ostensibly receive
hospital/specialist services through one
institution. This allows screening programs
and community outreach to be targeted more
accurately.
The
regulatory environment is generally supportive
of clinical trials with key staff from the
governments regulatory agency (MEDSAFE)
readily available for consultation
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should the need arise. Submission to
MEDSAFE can run in parallel with submission to the
local Ethics Committee, with MEDSAFE approval usually
received prior to ethics approval. All ethics
committees in NZ use the same application form [link
to National Ethics Application form]. Ethics
approval would typically be received within 60 days from the date of submission.
New
Zealand physicians have a close geographical and
professional relationship with their peers from
Australia. If you have study sites in Australia, then
involvement of New Zealand sites will significantly
increase the pool of potential subjects available to
your project without unduly affecting the
administration/management of the project.
"Australian
and New Zealand Governments intend to establish a
single bi-national agency to regulate therapeutic
products, including medical devices and prescription,
over the counter and complementary medicines. The
single agency will replace the Australian Therapeutic
Goods Administration (TGA) and the New Zealand
Medicines and Medical Devices Safety Authority (MEDSAFE),
will be accountable to both the Australian and New
Zealand Governments. The agency is expected to
commence operation in 2005."
If
you intend to conduct clinical research in Australia
then the inclusion of New Zealand sites will be a cost
effective, quality addition to your research program
which will ultimately increase the likelihood of
recruitment/trial success � RAL can assist you with
the logistics involved in
initiating/monitoring/completing your project in NZ.
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