Reporting process of randomized controlled trials
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* Walter P. Maksymowych

Andreas Laupacis and colleagues1 raise important concerns regarding the almost complete lack of an appropriate process for evaluating newly approved therapeutics once they are in widespread clinical practice in Canada. Their suggestion for Centres of Excellence in Pharmacosurveillance is promising and deserves further scrutiny, particularly because the regionalization of health care services positions Canada as a potential international leader in this area.

An example of how such a centre would work is already available. In Alberta the introduction of the biological therapies infliximab and etanercept for the treatment of rheumatoid arthritis has been accompanied by a mandatory program of pharmacosurveillance developed by rheumatologists at the University of Alberta and the University of Calgary. The Rheumatoid Arthritis Pharmacovigilance Program and Outcomes Research in Therapeutics (RAPPORT) Team has developed a systematic approach to collecting data on effectiveness, adverse events and cost-effectiveness for all Alberta patients receiving these agents for the treatment of rheumatoid arthritis.2 What is additionally unique about this program is the application of defined and validated criteria in the ongoing surveillance of effectiveness; this ensures that patients who no longer meet the response criteria are withdrawn from these costly therapies, which in turn ensures accountability for dollars spent. This operational model of pharmacosurveillance has become enmeshed with routine clinical practice and illustrates what can be accomplished through a committed partnership involving academia, government payers and industry.

**Walter P. Maksymowych** Chair, Scientific Committee RAPPORT Professor of Medicine University of Alberta Edmonton, Alta.

## References

1.  1. Laupacis A, Paterson JM, Mamdani M, Rostom A, Anderson GM. Gaps in the evaluation and monitoring of new pharmaceuticals: proposal for a different approach [editorial]. CMAJ 2003;169 (11): 1167-70.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMToiMTY5LzExLzExNjciO3M6NDoiYXRvbSI7czoyMzoiL2NtYWovMTcwLzkvMTM3NS4yLmF0b20iO31zOjg6ImZyYWdtZW50IjtzOjA6IiI7fQ==) 

2.  2. Barr S, Maksymowych W, Steber W, Mallon C, Martin L. “Real-world” effectiveness of infliximab and leflunomide: the Alberta experience [abstract]. Annual meeting of Canadian Rheumatology Association; Lake Louise, Alta.; 2004 Feb 25-28. *J Rheumatol*. In press.