Health Canada Issues Guidance on Off-Label Uses of Drugs in Trials

Health Canada released new guidance that the agency hopes will make it easier to study the off-label benefits of drugs in clinical trials.

Canadian regulations currently require any treatments purchased for clinical trials for their off-label properties to be designated “investigational drugs.” But Canadian officials worry that’s adding unnecessary hurdles that slow life-saving or life-changing research.

Under the new guidelines, Canadian officials will ask a series of questions about a given treatment before deciding whether it has to be designated an investigational drug, including:

• Does the drug have “an established safety profile when used off-label in the study population;”
• Is it being used as part of a comparator arm in a clinical trial, as supportive or rescue therapy, or whether it’s part of a standard therapy “that another investigation drug is being used to supplement in the investigational arm of the trial;”
• Is there any uncertainty about the risks and benefits of the off-label use;
• Is the drug already authorized in Canada and will trial doses will be bought in Canada;
• Does the off-label use increase the risks for patients beyond the normal risks of taking the medicine; and
• Is it “otherwise clear that the drug to be used off-label is not being tested in the clinical trial.”

Sponsors will have to provide the proposed off-label drug’s Notice of Compliance or Drug Identification Number and explain what the original indication was for. They also will have to explain the proposed off-label use in the trial, how the proposed use is “consistent with current or recognized medical practice,” why the off-label use shouldn’t be considered as a separate clinical trial, and the risks of off-label use, the agency says.

Read the guidance here: https://bit.ly/2XIl2Wy.