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Stuart M. MacLeod
Judith A Soon
Sunaina Sharma
Matthew O. Wiens


Human resources, clinical evaluation, drug safety, drug efficacy/effectiveness, pharmacoepidemiology


Achievement of optimal therapeutics requires individuals with analytic skills appropriate to the balancing of enterprise, innovation and the need for rigorous scientific validation. A synergistic convergence of discovery research, clinical investigation, evaluative, regulatory and implementation sciences will be essential. None of the needed research capacities are likely to prove obtainable on demand. On the contrary, they require accurate projection of future needs and careful planning of post-secondary training programs.

A survey conducted for Health Canada in 2010 revealed significant shortfalls in research skills available outside government and industry. This commentary argues that such an environment represents an outstanding opportunity for the academic community to demonstrate that it is eager to meet the needs of the Canadian public. University leaders should be assertive about their commitment to the ideals of patient oriented research and all governments should be clear about deliverables anticipated in return for consistent post-secondary funding.

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1. Council of Canadian Academies, 2012. The state of science and technology in Canada. Ottawa, ON: Expert panel on the state of science and technology in Canada, Council of Canadian Academies. sments%20and%20publications%20and%20ne ws%20releases/SandT_II/StateofST2012_fullre portEN.pdf ( October 8 , 2014)
2. Council of Canadian Academies, 2013. Paradox Lost: Explaining Canada’s research strength and innovation weakness. Ottawa, ON: Advisory Group, Council of Canadian Academies sments%20and%20publications%20and%20ne ws%20releases/synthesis/paradoxlost_en.pdf ( October 8, 2014)
3. Coalition for action on innovation in Canada: An action plan for prosperity. (October 2010) p?fileid=filevRwhbmwSwo&filename=file_Co altion_for_Innovation_2010_report_2.pdf ( October 8 , 2014)
4. Innovation Canada: A call to action. Review of federal support to research and development – expert panel report. (2011) http://rd - ( October 8 , 2014)
5. Government of Canada Budget 2014. - accueil-eng.html ( October 8 , 2014)
6. Canadian Institutes for Health Research. Strategy for patient-oriented research. http://www.cihr - ( October 8 , 2014)
7. Canadian Institutes for Health Research. External Advisory Committee Report: Training and Career Development in Patient-Oriented Research. (2013) http://www.cihr - ( October 8 , 2014)
8. Avorn J. In defense of pharmacoepidemiology - embracing the yin and yang of drug research. N Engl J Med 2007;357:2219 - 21. doi: 10.1056/NEJMp0706892
9. Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions. The ISPOR Real-World Data Task Force Report. Value in Health 2007;10:326 - 35.
10. Scott SA. Clinical Pharmacogenomics: Opportunities and challenges at point of care. Clin Pharm Ther 2013;93:33 - 5.doi: 10.1038/clpt.2012.196.
11. Whirl - Carillo M, McDonagh RM, Hebert JM, et al. Pharmacogenomics knowledge for personalized medicine. Clin Pharm Ther 2012;92:414 - 7. doi:10.1038/c lpt.2012.96
12. Roden DM, Tyndale RF. Pharmacogenomics at the tipping point: Challenges and opportunities. Clin Pharm Ther 2011;89:323 - 27. doi:10.1038/clpt.2010.340
13. Lee DK, Wong B. An orphan drug framework (ODF) for Canada. J Popul Ther Clin Pharm 2014;21:e42 - 6.
14. Health Canada. Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), Amendments to the Food and Drugs Act (Bill C - 17) cation.aspx?Language=E&Mode=1&DocId=66 7641 ( October 8 , 2014)
15. Standing Senate Committee on Social Affairs, Science and Technology. Canada’s clinical trial infrastructure. A prescription of improved access to new medicines. (November 1, 2012) /411/soci/dpk/01nov12/home - e.htm ( October 8 , 2014)
16. Standing Senate Committee on Social Affairs, Science and Technology. Prescription pharmaceuticals in Canada: Post-approval monitoring of safety and effectiveness. (March 2013) /411/SOCI/DPK/01mar13/home - e.htm ( October 8 , 2014)
17. Standing Senate Committee on Social Affairs, Science and Technology. Prescription Pharmaceuticals in Canada. Off - label use. ( January 2014) /412/soci/rep/rep05jan14 - e.pdf ( October 8 , 2014)
18. Yeates N, Lee DK, Maher M. Health Canada’s progressive licensing framework. Can Med Assoc J 2007;176:1845 - 7. doi:10.1503/cmaj.070597
19. Soon JA, MacLeod SM, Sharma S, Wiens MO. Human resource and educational inventories to support the life cycle approach to the regulation of therapeutic product. Health Canada report March 2010. http://www.hc - - asc/pubs/hpfb - dgpsa/reshum - eng.php ( October 8 , 2014)
20. Vancouver Sun Op-ed: Therapeutic evaluation requires careful navigation (January 15, 2013) s/news02131303.aspx ( October 8 , 2014)
21. Three Missions...One Future - Optimizing the Performance of Canada's Academic Health Sciences Centres (May 30, 2010) ( October 8, 2014 )