Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
Updated: September 29, 2020
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The COVID-19 pandemic is having an impact on how clinical trials are being conducted. For example, people participating in trials must practise physical distancing and other public health recommendations. Also, clinical trial staff are being transferred to other duties, which is causing some delays.
Clinical trials must follow the requirements of the protocol, which is authorized by Health Canada and approved by the Research Ethics Board. This requirement is set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR).
During the pandemic, there may be some protocol deviations. However, it is important to continue to protect patient safety and ensure that data are not compromised.
Clinical trial applications that investigate how to prevent, mitigate or treat COVID-19 are given priority.
To reduce regulatory burden, we have 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
Sponsors may continue to file COVID or other clinical trial applications and amendments according to Health Canada guidance.
During a review of a clinical trial application, we may ask for more information. If a sponsor is unable to respond within the requested timeline, they should consider:
- withdrawing their application and
- re-applying when they have the information
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:
- note the reasons for doing so in the study records
- inform Health Canada using a clinical trial application notification (CTA-N)
- retrain trial staff if the trial is halted for a few months
Guidelines for the management of clinical trial participants are as follows:
- carry out eligibility assessments as usual
- ensure that persons enrolled in a trial meet the pre-set eligibility criteria
- document medical oversight for the determination of participants eligibility to take part in the study
- inform study participants of any changes to both the study and monitoring plan that could affect their well-being
- consider having the participant drop out of the study if the safety of a participant may be at risk by missing a pre-defined study visit even though appropriate mitigation measures are in place
- identify all participants affected by a COVID-19-related study disruption with a unique participant identifier, document the site and describe how the individual’s participation was changed
- discuss risks and risk mitigation strategies for the use of any immunosuppressive agents with medical immunology specialists
- discuss with local research ethics boards if it is in the best interest of the safety, welfare and rights of the participant to continue the study
- consider putting in place different safety monitoring measures if participants no longer have access to the study site
For COVID-19 testing and screening:
- If an institution requires that people who attend clinical visits be screened, there is no need to amend the study protocol. The only exception is if the data are being included in a new research objective.
For informed consent:
- discuss with the research ethics board different methods of informed consent for the study or changes to the study protocol if in-person visits are not possible
- such as electronic consent or recorded telephone consent
- ensure participants always have an opportunity to ask questions before they give their consent
- consider accepting a text or email of a picture of a signed and dated written statement for participants who enroll remotely
- this statement should indicate they are voluntarily accepting participation in the trial
- if consent is given verbally, read the consent to the prospective participant and provide an opportunity for the person to ask questions
- consider providing the document ahead of time to the person
- make sure a witness is present and signs an attestation
- the witness can be a family member (can be on a conference call)
- a scanned copy of the attestation can be forwarded to the investigator by email or a picture of the signed attestation can be sent by email or text
- the conversation may be recorded if it is not possible to have a witness (this recording becomes part of the trial records)
- check to see if your research ethics board has requirements for an attestation (we do not require a specific form)
Participants with COVID-19
Sponsors must decide quickly whether the participation of someone affected by COVID-19 should be:
- placed on hold (the investigational product is not administered until the participant has recovered) or
Notify Health Canada of any participant who contracts COVID-19 during the study. Carefully consider whether you should put in place additional mitigation measures or suspend the trial.
The physical site where visits are held may have to be changed. This may cause confidentiality issues around the participant’s medical records (electronic health record).
Trial participants will need to consent to any identifiers leaving the original site and be assured that their confidentiality will be protected.
For alternative sites for laboratories, diagnostic imaging, and so on:
- verify if these other facilities are able to perform the activities as per the approved protocol
- add copies of the normal value ranges and accreditation certificate of these facilities to your trial records
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.
Make sure to:
- prioritize monitoring of critical activities that ensure participant safety and data integrity
- consider central monitoring
- document any changes and their impact
Sample collection and storage
Always treat human biospecimens as potentially infectious. Follow your biosafety protocols.
Distribution of product
The shipment of clinical trial investigational products from Canadian sites directly to patients is not prohibited under the Food and Drug Regulations (FDR). Product formulations that are acceptable for direct shipment are:
- tablets and injectables that a participant could take on their own
- medications that do not have to be administered in a hospital or clinic
- medications that do not have any special conditions for handling
When transporting, handling and storing investigational products, make sure to reduce the risk of exposure to temperatures outside labelled storage conditions. Please see our guidelines for temperature control of drug products during storage and transportation (GUI-0069).
Make sure that:
- the investigational drug has been received by the participant (verification is required)
- record-keeping complies with the regulatory requirements of section C.05.012 of the FDR (as per C.05.012(3)(e), maintain complete and accurate records for a drug used in a clinical trial, including records for shipping, receiving, disposing, returning and destroying the drug)
- the process in the participant’s study record is accurately documented.
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
- 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 our guidance for Part C, Division 5 of the FDR “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100).
For questions about this notification or the regulation of clinical trials, contact Health Canada.
For pharmaceutical drugs:
Therapeutic Products Directorate
Office of Clinical Trials
5th Floor, Holland Cross, Tower B
A/L 3105A, 1600 Scott St
Ottawa ON K1A 0K9
For biologics and radiopharmaceuticals:
Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
0601C-100 Eglantine Dwy
Ottawa ON K1A 0K9
For clinical trial compliance:
Regulatory Operations and Enforcement Branch
Clinical Trial Compliance Program
1903C-200 Eglantine Dwy
Ottawa ON K1A 0K9
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