Authorities in Canada are changing the rules for clinical trials. They’re taking a more proactive stance than colleagues in Britain, which saw 6 patients severely injured in a clinical trial earlier in 2006. (In the most serious case, one British patient lost his fingers and toes.) The Canadians have implemented sweeping new procedures for clinical trials certain to complicate the scientific and business aspects of local and global trials.

The background, according to Canadian newspapers…

A patient infected with TB was inadvertently included in a Montreal study under the auspices of Anapharm, a publicly-traded Canadian contract research organization with approximately 750 employees. Canadian press reports say the patient infected 20 other people, both staff and other trial participants. Under Canadian law, there is no record of any sanctions against Anapharm.

In procedures reminiscent of what blood donors must endure in the U.S., the Canadians running clinical trials will now be required to screen all patients for obvious signs of infectious disease. Prospective patients will be asked if they are HIV-positive or intravenous drug users, among a long list of other questions about dialysis, cancer, night sweats, chest pain, weight loss and appetite changes.

“They did, as a result of this, create guidelines for first-phase clinical trials,” confirmed Alistair Sinclair, spokesman for Health Canada. “And they are binding. Companies are required to abide by them.”

The rule changes will only make patient recruitment more difficult in Canada. Although the patient recruitment environment in Canada is significantly easier than in the U.S. (thanks to national health insurance and higher trust in physicians) the addition of new inclusion and exclusion criteria will complicate both recruiting procedures and trial designs.

In a new study in the Lancet, British authorities have again sighed deeply and expressed their regrets. The latest revelation is that TeGenero, the German company sponsoring the ill-fated London trial, “neglected” to include animal data with their British regulatory documents to start the trial. There were several limited assessments of the trial’s safety, the Lancet suggests, but not a single review that examined the whole trial.