Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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2 BRITISH COLUMBIA EXECUTIVE SUMMARY With its Province-wide single-payer government healthcare program, uniform treatment policies, ethnically diverse rapidly growing population of approximately 4.4 million people, and world class investigators, B.C. is a hot bed for clinical trials. The Province houses at least 59 clinical trials units (CTUs), centres, and study sites, as well as six clinical trials support units. All CTUs, centres, and study sites have Quality Control (QC) and Quality Assurance (QA) measures in place and work closely with the Province’s Research Ethics Boards (REBs). Over the past five years (2005/6 to 2009/10) B.C. physicians have conducted over 2,100 clinical trials, excluding investigator-initiated studies. These trials were sponsored with over $100M by industry, governments, patient groups, and other not-for-profit organizations. Sixty-two percent of the funds were obtained from 260 companies, including all of the world’s top pharmaceutical and biotech companies. This money financed 78% of the projects. Clinical trials in B.C. cover all major disease areas. The most important, based on number of studies over the past five years, are those conducted in cancer (23%). In terms of funding, clinical trials in infectious diseases/ infection receive the most money (24%). Cardiovascular/ cardiology and CNS disorders are also areas of clinical strength, accounting for 18% and 15% of individual trials and 9% and 17% of funds, respectively. Furthermore, of the Province’s 59 CTUs, centres, and study sites, 11 focus on cancer/ hematology, 10 on CNS disorders, five on infectious diseases, and four on cardiology. In all disease areas, the main focus of clinical trials is drug therapies. Over the past five years 62% of all funds for single trials, and 80% of the studies, have been dedicated to pharmaceuticals. At least 560 investigators in B.C. have received funding to conduct clinical trials over the past five years, including 16 who hold endowed Chairs. The distribution of investigator expertise broadly reflects the number of clinical trials, with 127 working in cancer, 99 in cardiovascular diseases /cardiology, 85 in CNS disorders, and 48 in infectious diseases. With the largest full-service child health centre in Western Canada (B.C. Children’s Hospital) pediatrics is also an important area for clinical trials with at least 86 investigators. Clinical trials have included major components in health economics, health outcomes other than response to experimental therapy, and epidemiology. Approximately 48 investigators have been involved in epidemiological aspects of clinical trials, 45 in health outcomes, and 15 in other aspects of health economics. In addition, the Province has nine health economics and health outcomes research facilities, and 13 centres that focus on epidemiology and surveillance. B.C.’s physicians have expertise in all Phases of clinical trials, from first human use studies to Phase IV. The Province’s strengths in the former are under-pinned by a number of cutting-edge technical and informatics platforms, such as genomics, pharmacogenomics, proteomics, and microarrays, as well as expertise in the translation and development of biomarkers. B.C.’s physicians are also pivotal players in many national and international clinical research and trials networks, with a number of those networks based in the Province. Investigators are the founders or co-founders of the Canadian Pharmacogenomics Network for Drug Safety, the CIHR Canadian HIV
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 3 Trials Network, PrioNet Canada, the SARS Accelerated Vaccine Initiative (SAVI), the Canadian Urologic Oncology Group, and various NCIC Clinical Trials Groups. These and other networks give B.C.’s investigators unsurpassed links to external experts and resources. Moreover, there are 13 Provincial healthcare-related networks that harness internal expertise and expand the sum of the parts. Four of these are disease-based. B.C. also contains a great deal of other public infrastructure to support clinical trials. This includes comprehensive tissue databases and patient registries that are aligned with many Provincial research opportunities. Furthermore, B.C. has 24 disease-based and 14 population based (i.e., focused on children, youth, women, the elderly, aboriginals) healthcare research centres that conduct research to aid disease/ health management. As well as the public facilities described above, the Province is home to at least 25 independent organizations that offer clinical trials services, including 16 focused on clinical trials operations and five that offer analytical services. At least 21 of these organizations are home-grown companies. In addition to these clinical trials companies, B.C. has at least six major organizations offering preclinical services, including analytical services, medical device development, and preclinical drug development. The Province’s investigators and companies are keen to collaborate with companies, clinical trials networks, and other interested parties in the conduct of new clinical trials, particularly those that are research intensive (high content).
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