COVID-19 clinical trials IO and clinical trials records retention: Consultation report
Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention.
On this page
- COVID-19 clinical trials interim order and consultation
- Topics addressed during the consultation
- Other comments and questions
- Conclusion of consultation
COVID-19 clinical trials interim order and consultation
On May 23, 2020, the Minister of Health approved the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. This Interim Order (IO) responds to the need for urgent COVID-19 diagnosis, treatment, mitigation or prevention options. An IO is one of the fastest ways the federal government can make health products available during larger-scale public health emergencies. An IO is temporary in nature.
We intend to:
- maintain the flexibilities and regulatory oversight provided by the IO until the fall of 2021
- propose regulatory amendments to allow the flexibilities under the IO to continue after the fall of 2021
On Monday, December 14, 2020, we hosted 2 virtual consultation sessions. A total of 98 external stakeholders attended. The purpose of the consultation sessions was to:
- discuss the transition of the IO into regulations
- propose a reduction in records retention requirements
We accepted written comments until January 25, 2021. Stakeholders provided feedback and comments on the:
- COVID-19 context and continued response
- Interim Order and its key flexibilities, as well as stakeholder experience to date
- proposal to extend the IO and transition into regulations
- proposed requirements for retaining clinical trial records
- cost-benefit analysis survey
We evaluated stakeholder questions and comments received during the virtual consultations. The results are summarized in this report.
Topics addressed during the consultation
We addressed 3 main areas during the consultation.
Overall, stakeholders sought:
- greater support for smaller companies to help with study participant recruitment
- clarity around the need to file a separate Investigational Testing Authorization for an unlicensed medical device that is being used in combination with an investigational drug for which a Clinical Trial Authorization is also being filed
Records retention for clinical trials
During the consultation, we proposed changes to how long clinical trial records need to be retained. We proposed that sponsors retain clinical trial records for a period of 15 years for:
- COVID-19 medical devices and drugs trials authorized under the current and proposed interim order. This would extend the records retention period beyond the duration authorized under the current interim order, which is limited to 12 months.
- COVID-19 medical devices and drugs trials regulated under the proposed transition regulations, which temporarily extends flexibilities for COVID-19 trials authorized under the IO until a permanent regulatory framework for Clinical Trials Modernization comes into force.
- Non COVID-19 drugs and natural health product clinical trials authorized under the Food and Drug Regulations (C.05.012) and the Natural Health Products Regulations (section 76).
We also presented possible exceptions to the proposed requirements. In response to the proposal, stakeholders requested greater clarity in the requirements for retaining records of trials that are closed and the definition of the end of the trial.
Informed consent for clinical trials
Extending the IO provisions enables alternate means of obtaining the informed consent of trial participants. We are looking at different ways to obtain informed consent in the future through the Clinical Trial Modernization initiative. One stakeholder raised the issue of differences in legislation between provinces in terms of providing informed consent.
Other comments and questions
The IO introduced key flexibilities while upholding strong patient safety and data reliability requirements. One stakeholder requested clarity about the notification requirements of the Food and Drug Regulations for applications authorized under the IO and the submission of updated Investigator Brochures.
Conclusion of consultation
Stakeholders asked questions about 3 distinct areas including:
- medical devices
- records retention
- informed consent
We will continue to communicate with stakeholders to keep them informed about extending the IO and transitioning it into regulations. The feedback from these consultations will also help us understand the potential challenges when moving forward with the Clinical Trials Modernization framework.
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