Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic.

 

New trials

To reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical devices and drugs relating to COVID-19. Sponsors of clinical trial applications for COVID-19 must indicate if they are filing the application under this new pathway:

  • in the cover letter and
  • on the revised 3011 form

 

Ongoing trials

Sponsors of a current trial must document the measures they took to stop or lower the risk of becoming infected with COVID-19. Any changes to the protocol or status of the study should consider:

  • the burden on resources due to the COVID-19 pandemic
  • whether participants are at high risk of contracting the virus and
  • whether these changes still allow adherence to public health recommendations

Plans to add extra study sites and recruit more people may need to be halted.

Sponsors who cancel a trial or temporarily stop or halt recruitment should:

 

Monitoring

Assess whether other safety assessment methods are possible when participants are unable to come to the investigational sites as specified in the study protocol.

If alternative monitoring is done, careful documentation will be required to capture:

  • the reason why it was done
  • the method used to collect the information
  • the types of data that were collected
  • who provided the information
  • how the source of the information was verified

You will not need to submit a protocol amendment.

 

Protocol deviations

For clinical trial sites:

  • ensure there is a system in place to identify, document, assess and report all protocol deviations to the sponsor and research ethics board in accordance with their own requirements
    • document these deviations to make it easier to analyze the study findings in the future

For sponsors:

  • define and identify the protocol deviations to be reported (you will not have to report these to us individually unless the deviations may place participants at risk)
  • consider alternate methods to prevent protocol deviations and document the reasons for these deviations
  • submit a clinical trial application amendment when changes to the protocol meet the definition of a clinical trial amendment (don’t file repeated deviations)
  • consider submitting at regular intervals a cumulative list of deviations occurring in a particular study, rather than individual notifications

For detailed guidance on complying with the regulations, please see Health Canada guidance for Part C, Division 5 of the FDR “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100).

For more information, please visit the Health Canada website.

Meditrial can help, Contact us now

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials: