Regulatory Focus™ > News Articles > 2020 > 5 > Health Canada releases guidance to streamline COVID-19 clinical trials

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Posted 28 May 2020 | By Kari Oakes 

Health Canada releases guidance to streamline COVID-19 clinical trials

2953 Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.
The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.
The IO has dropped administrative requirements for non-significant changes during a clinical trial; only changes that are significant now need approval. Also, trials may now engage a broader range of investigators and obtain informed consent in a variety of ways.
Health Canada’s IO also reduces the administrative requirements for trials that involve new uses of drugs and medical devices that are already being marketed.
These adjustments, said HC, will be of particular benefit for such complex clinical trials as multi-site, multi-arm and remote trials, and those that involve repurposing drugs and devices.
Required clinical trial reviews by Health Canada and a Research Ethics Board (REB) have also been prioritized for COVID-19 related drugs and devices but must still take place.
The scope of the two guidance documents, one for drug clinical trials and one for medical devices,  includes trials related to COVID-19 for pharmaceutical and biologic drugs, including blood and blood components; medical devices and combination products are also included. The IO and guidances apply to clinical trials in phases I-III.
The IO does not obviate requirements not specifically adjusted in the order and accompanying guidances, noted Health Canada. Specifically, trial-related adverse event reporting should continue.
Also, Health Canada retains oversight flexibility, and may intervene in trials “when required to safeguard the best interests of clinical trial participants.”
This flexibility includes “being able to partially suspend or revoke a trial. This will allow the suspension of one arm, or treatment group, of a randomized trial, if needed. The rest of the trial would be allowed to proceed so that other participants can continue to receive a prospective therapy,” said Health Canada.
Health Canada clarified that once an applicant requests authorization under the IO mechanism, that pathway must be followed. Similarly, trials already underway cannot be transitioned to the new pathway.
The guidance documents for COVID-19-related clinical trials of drugs and medical devices are effective for one year from the date posted.


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