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…