[The author responds:]
As I understand his argument, Dr. Paul Lee asserts that randomized trials (including Canadian ones) can't occur without bench research (especially Canadian). But doesn't his assertion overlook about 35 000 surgical, educational and health care trials, most of which required no prior bench research? And doesn't he defeat his own argument with the 3 recent drug trials he does cite (2 led from Canada and the other with major Canadian collaboration)? PRISM-PLUS was conducted in 12 countries, HOPE in 16 and GUSTO in 10, but only 15% of the references in these published studies were about bench research (which the investigators were comfortable to extrapolate from laboratories in just 8 countries), and 85% of their cited justification came from previous trials or clinical surveys.
Second, the need to elucidate the molecular basis for diseases affecting our First Nations families is met by shipping appropriate specimens to the best laboratories in the world. It doesn't require that the bench research be carried out in Canada; the performance of reverse transcriptase is the same in Ottawa, Omaha, Oslo and Oxford. In sharp contrast, the performance of the health care organizational elements that profoundly affect the compliance, comorbidity, co-intervention, costs of care and consequent outcomes of patients in randomized trials differs widely in these 4 sites, and these differences may require separate trials (and their associated economic analyses) in each country.
Responding to my editorial1 on behalf of the Medical Research Council of Canada, Dr. Mark Bisby reported the recent growth in Medical Research Council support of randomized trials from a level that was shamefully low to one that remains profoundly inadequate.2 Given that this increased level of support, on a per citizen basis, is still far less than 10% of the rate provided American trials by the US National Institutes of Health, I see no grounds for altering my recommendation that it is time to put the Canadian Institutes for Health Research on trial.
The immediate health consequences of rejecting grant applications for good Canadian bench research and good Canadian trials are fundamentally different. I hope CMAJ readers noted that neither Dr. Lee nor Dr. Bisby challenged my conclusion that the opportunity cost of failing to fund scientifically sound Canadian randomized clinical trials includes the disability and untimely death of Canadians.
References
- 1.
- 2.