Interim Order for COVID-19 Clinical Trials

Summary#

This Order in Council approves Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, the temporary set of rules Health Canada used to speed up certain COVID-19 clinical trials. The interim order was made by the Minister of Health on May 3, 2021 and the approval was recorded on May 14, 2021; the notice appeared in the Canada Gazette on May 22, 2021.

What it does#

• Keeps in place an optional, pandemic-specific pathway for authorizing clinical trials of COVID-19-related drugs (including biologics) and Class II to IV medical devices.
• Expands who can act as a trial supervisor by widening the definition of “qualified investigator” to include additional licensed health professionals (for example, nurse practitioners). This makes it easier to run trials where physicians are scarce.
• Lets investigators (for example, researchers, clinicians, or health-care facilities) — not just manufacturers or importers — apply to run medical device trials.
• Allows two flexible consent methods when participants cannot sign in person:
  • remote written consent when the participant is not in the same location as the investigator, and
  • non-written consent when the participant cannot provide a written signature.
• Reduces some administrative and reporting burdens for trials using already-marketed drugs within standard care, and asks for amendments only for significant, higher-risk changes.
• Keeps oversight powers for the Minister of Health and Health Canada, including:
  • adding terms and conditions to authorizations,
  • requesting extra information, and
  • suspending or cancelling all or part of a trial (including suspending a single treatment arm while letting other parts continue).
• Maintains existing authorizations issued under the earlier interim order and treats outstanding applications made under Interim Order No. 1 as applications under IO No. 2.
• Sets a time limit: IO No. 2 will cease on repeal, when any replacing regulations come into force, or after one year from when it was made.

Who's affected#

• Clinical trial sponsors and applicants, including drug and device companies, academic researchers, hospitals, and independent investigators.
• Health-care professionals who may now act as supervisors (for example, nurse practitioners) in some trials.
• Research ethics boards and institutions that review and run trials.
• People asked to join COVID-19 clinical trials, especially patients in hospitals, people in isolation, and participants in remote or Northern communities.
• Manufacturers and importers of medical devices (their usual role as applicants is now one option among others).
• If unclear: the notice does not list every affected group, but focuses on those involved in designing, approving, overseeing, or participating in clinical trials.

Why it matters#

• It makes it easier and faster to set up and run COVID-19 clinical trials, including multi-site and remote trials. That can speed evaluation of treatments and devices during the pandemic.
• Allowing more kinds of qualified investigators and remote consent helps trials reach patients in communities with few physicians and where in-person paperwork is difficult because of infection control or isolation.
• Reduced paperwork and a more flexible amendment process can lower administrative barriers for researchers and institutions.
• The Minister and Health Canada keep powers to act if safety problems appear, so the changes aim to balance speed with participant protection.
• The interim order is temporary and limited in time, so these changes are a short-term response while the pandemic continues and until permanent rules are made.