Interim Order to facilitate COVID-19 Clinical Trials related to Drugs and Medical Device
Author: Preetha Prabhu
On May 23, 2020, the Minister of Health signed an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. This IO has been approved as a step taken to accelerate access to health products for COVID-19 by introducing regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently. However, this IO does not apply to radiopharmaceutical drugs, natural health products and Class I medical devices.
As part of the search for therapies to treat, diagnose, mitigate or prevent the COVID-19 infection, till date, Health Canada has approved 37 clinical trials for potential COVID-19 therapies and vaccines. Through the IO, the Minister of Health has authorized the following change for a more flexible process for clinical trials related to COVID-19, while upholding the safety of participants or the reliability of trial data:
- Reduce administrative requirements for assessing the use of existing marketed products as possible COVID-19-related therapies.
- Allow alternate means of obtaining patient consent in light of COVID-19 realities.
- Allow a wider range of health professionals, such as nurse practitioners, to be involved in running clinical trials. Under current regulations, only physicians and dentists can conduct clinical trials for drugs.
- Allow a wider range of investigators, such as physicians, to be involved in running clinical trials for medical devices. Under current regulations, only manufacturers can conduct clinical trials for medical devices.
- Reduce the burden associated with labelling and record-keeping requirements for clinical trials involving drugs that are already marketed for other indications and are being studied to treat COVID-19.
- Enable multiple-stream clinical trials to continue even when one stream has been stopped.
- Enable more clinical trials by allowing trials where direct interaction with the participant is not feasible, for example when participants who live in remote locations are unable to travel.
As with all drugs and medical devices, Health Canada will assess and monitor the safety of the drugs and medical devices being investigated under this IO, and will take immediate action to protect the health and safety of Canadians, if necessary.
In addition, Health Canada and the Canadian Institutes of Health Research (CIHR), in collaboration with the Canadian Association of Research Ethics Boards (CAREB), has issued a Joint Statement on Clinical Trial Oversight in Canada. The statement announces a new initiative to have monthly engagement sessions where policy makers, regulators, funders and oversight bodies will collaborate and share information on clinical trials.
- Health Canada announces another step to accelerate access to health products for COVID-19 https://www.canada.ca/en/health-canada/news/2020/05/health-canada-announces-another-step-to-accelerate-access-to-health-products-for-covid-19.html
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/notice-interim-order.html