Sask. Cancer Agency started chemotherapy drug trial without required Health Canada approval
Agency says it 'proactively' paused trial 5 months after it started
The Saskatchewan Cancer Agency says it has "paused" a clinical trial of chemotherapy drugs to apply for Health Canada approval that it was supposed to have before the trial started.
The Saskatoon Cancer Centre, which is part of the agency, started a clinical trial of the drugs Folfox and Folfiri in September 2018.
The cancer centre had not made a clinical trial application — a Health Canada requirement to proceed with the trial — at the time the trial began.
The agency said in a written response to questions that it has put the trial on hold.
"The Saskatchewan Cancer Agency ... proactively paused the trial in February 2019 to investigate and subsequently reached out to Health Canada in April 2019 to ensure we were complying with regulations," the agency said in a written statement.
In May 2019, Health Canada replied to say the centre did in fact need approval for the trial.
The cancer agency said the type of chemotherapy used in the study already has approval to be used for treatment but not for research purposes.
The clinical trial has all of the necessary approvals by the University of Saskatchewan's ethics committee and no complaints have been filed, according to a university spokesperson. The university has sponsored the trial.
The four patients of the trial and the U of S's ethics unit have been made aware the trial has not yet received approval from Health Canada, the spokesperson added.
Treatment to continue for patients already enrolled
"Patient care has not and will not [be] affected, as Health Canada has indicated that patients currently enrolled in the trial who are benefiting from the therapy can continue treatment," said the agency, whose director of clinical trials was not available to be interviewed Monday.
"Rather, enrolments in the trial and the collection of data for research purposes has been halted."
Health Canada confirmed on Monday it was contacted by a researcher from the Saskatoon Cancer Centre asking if the clinical trial application was needed.
"The Saskatoon Cancer Centre researcher was advised that when a researcher wishes to investigate the use of a drug in a clinical trial, and this use is outside the approved conditions of sale for that drug, it falls under federal jurisdiction, under the Food and Drug Regulations, which require a CTA [clinical trial application] to be submitted to Health Canada," the federal health department said in a written response to questions.
"This situation is different from off-label use of drugs (i.e. use of a drug outside the approved conditions of use), which is patient-specific and is regulated by provincial colleges of physicians."
CTA 'being submitted'
The cancer agency initially told CBC News on Friday it had submitted the clinical trial application, but said Monday it is "being submitted."
Health Canada said Monday it had not received a CTA for the trial, adding that it has asked the agency to provide a "summary of actions taken" along with the CTA.
The agency said it has not been asked by Health Canada to shut down the trial, known as the Logic trial, adding that it does have approval from the Research Ethics Board.
The agency has not yet addressed why the application was not filed.
According to a recruitment listing on canadiancancertrials.ca, trial participants with gastric or esophageal cancer — and no prior advanced treatment — were eligible for the trial.
The same listing said the trial was looking for 36 patients to participate.
Health Canada said it would take "enforcement action" if it identifies any non-compliance with federal regulations.