Author: Preetha Prabhu
On Apr. 22, 2020, Health Canada published a notice to clinical trial sponsors regarding management of clinical trials during the COVID-19 pandemic.
Health Canada is aware of the impact of the pandemic on the conduct of clinical trials, including the need for participants to self-isolate and deployment of healthcare personnel involved in clinical trials to other duties during this public health emergency, resulting in delays in completing certain tasks.
As per paragraph C.05.010(b) of the Food and Drug Regulations (FDR), the sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s). Health Canada recognizes that there may be an increase in protocol deviations during the COVID-19 pandemic.
Health Canada is providing below guidance/updates on management of clinical trials:
Clinical Trial applications (CTA):
- Health Canada will prioritize the review of CTAs related to COVID-19.
- Sponsors may continue to file other CTA and CTA amendments according to Health Canada guidance.
- During the course of a CTA review, if sponsors are unable to respond to an Information Request (IR) within specified timelines, consider withdrawing the submission without prejudice and refiling when the information is available.
Participants affected with COVID19:
- Sponsors must decide quickly whether the study should be placed on hold or whether the participant’s involvement should be discontinued.
- All participants affected by a COVID19 related study disruption should be documented by unique participant identifier, site and a description of how the individual’s participation was altered.
Trial Participants:
- The ongoing safety of trial participants must be maintained.
- Sponsors should discuss with REBs alternative methods of informed consent for the study or amendments to the study protocol if in-person visits are not possible.
Clinical trial visits:
- Investigators may need to choose alternative methods for safety assessment should participants not be able to come to the sites as specified in the study protocol and careful documentation will be required to capture the reason why it was done.
- Trial participants will need to consent to any identifiers leaving the original site and be assured that their confidentially will be protected.
Shipment of investigational product (IP) to participant:
The FDR do not prohibit the shipment of clinical trial investigational products (IP) from Canadian sites directly to patients. This approach would be acceptable for all product formulations (e.g., tablets, injectables); however, the following considerations and/or requirements should be kept in mind:
- Only considered for specific trial designs and drugs that a subject could take on their own.
- Products must be transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions.
- Accurate documentation of the process in the participant’s study record.
Participant recruitments: Sponsors should consider suspending additional site activation and recruitment.
Site monitoring: Consider central monitoring of clinical trials and document delayed site visits.
Protocol deviations: Consider alternate methods to prevent protocol deviations and document the reasons for any deviations. Unless the deviations may place participants at risk, sponsors will not be required to report these deviations to Health Canada.
Placing study on hold: In case of halting recruitment or temporarily halting the trial, a documentation of reasons for halting is required. In addition, the study holds should be notified to Health Canada as clinical trial notifications (CTA-N).
Reference:
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors (dated Apr. 22, 2020) - https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html