Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences
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4<br />
BRITISH COLUMBIA<br />
INTRODUCTION<br />
With its Province-wide single-payer government healthcare program <strong>and</strong> resulting uniform treatment<br />
policies, B.C. is a hot bed for clinical trials. Its well-regarded teaching hospitals house many clinical<br />
opinion leaders in various therapeutic areas, particularly in cancer; conditions of the central nervous<br />
system (CNS); cardiology; cardiovascular, pulmonary <strong>and</strong> genitourinary diseases; infectious diseases;<br />
pediatrics; <strong>and</strong> transplantation.<br />
This <strong>Asset</strong> <strong>Map</strong> has been produced to facilitate new <strong>and</strong> ongoing medical product development<br />
programs managed by local, national, <strong>and</strong> international organizations. It is a snapshot of B.C.’s<br />
infrastructure <strong>and</strong> capabilities for clinical <strong>and</strong>, to a much lesser extent, preclinical studies. It includes an<br />
analysis of industry-sponsored clinical trials, as well as those funded by peer-reviewed research grants,<br />
that took place between April 2005 <strong>and</strong> March 2010.<br />
The term “clinical trials” is used here to cover the testing <strong>and</strong> evaluation of interventions <strong>and</strong> diagnostic<br />
or prognostic tests in clinical or community settings. Studies can involve the evaluation of therapeutics<br />
or vaccines, medical devices <strong>and</strong> instruments (including diagnostics <strong>and</strong> biomarkers), rehabilitation<br />
programs, <strong>and</strong>/or surgical, dietary, or psychological/ behavioural interventions in accordance with<br />
Good <strong>Clinical</strong> Practice (GCP) regulations/ guidelines. They can range from “first human use” studies<br />
(e.g., proof of concept, identification of mechanisms of pathophysiology or disease) 1 to post-marketing<br />
surveillance. Social/ behavioural studies, such as childhood development, family dynamics, youth<br />
behaviour, healthcare access, health <strong>and</strong> social services or policy, health education, health culture, <strong>and</strong><br />
health <strong>and</strong> safety are not defined as clinical trials <strong>and</strong> are not included in this report.<br />
In today’s health care environment, the socioeconomic value of novel methods within the context of<br />
the overall health care system is often included as part of clinical trials in the form of health economics<br />
(including health technology assessment <strong>and</strong>/or health outcomes research). Epidemiology studies,<br />
when combined with clinical research (new treatment options) <strong>and</strong>/ or interventions (lifestyle<br />
modification) are also included in this <strong>Asset</strong> <strong>Map</strong> as clinical trials. Furthermore, clinical studies often<br />
depend on other supporting infrastructure, such as technology <strong>and</strong> informatics expertise, health<br />
surveillance facilities, <strong>and</strong> more basic clinical research. Information on all these supporting disciplines is<br />
summarized in this report. B.C.’s wealth of research in disease etiology <strong>and</strong> the discovery <strong>and</strong> preclinical<br />
development of therapeutic interventions or diagnostics is generally excluded from this report.<br />
Information on some of this can be found in previous <strong>Asset</strong> <strong>Map</strong>s 2 .<br />
As well as clinical trials facilities, the Province is also home to a number of organizations offering<br />
preclinical services. These facilities can involve the chemical or engineering development,<br />
characterization, purification, stability, <strong>and</strong> manufacturing of new medical products; the safety <strong>and</strong><br />
efficacy testing of pharmaceuticals in nonhuman systems, such as animals <strong>and</strong> cell cultures; <strong>and</strong> the<br />
sensitivity, specificity, <strong>and</strong> reproducibility testing of devices using relevant tissues or fluids. Such tests<br />
are conducted in accordance with Good Laboratory Practice (GLP), <strong>and</strong> for manufacturing, Good<br />
Manufacturing Practice (GMP) regulations.<br />
1<br />
Also known as Experimental Medicine.<br />
2<br />
www.investbc.ca/assetmaps.htm.