Cecily Zamora
Good Clinical Practice (GCP) is a set of international ethical and scientific standards that govern the conduct of clinical trials. It ensures the safety of trial participants, the integrity of the data collected, and the compliance of the trial with all applicable laws and regulations. In Canada, clinical trials are regulated by Health Canada (HC) and institutional ethics committees (ECs), known as Research Ethics Boards (REBs). Before a clinical trial can commence in Canada, it must be reviewed and approved by both HC and an EC, with no mandatory waiting period following approval. This process ensures that the trial adheres to GCP standards and protects the rights and well-being of participants.
| Characteristics | Values |
|---|---|
| Clinical trial application (CTA) review and approval | Conducted by Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) |
| Clinical trial commencement | Requires authorization from both Health Canada (HC) and an institutional ethics committee (EC) with no waiting period after approval |
| Clinical trial protocol template | Developed by the National Institutes of Health (NIH) and the FDA for NIH-funded investigators in phase 2 and 3 clinical trials that require IND applications |
| Clinical trial site information (CTSI) form | Required for each participating trial site and includes the trial commencement date |
| Compliance trends | Insight provided by FDA, MHRA, and Health Canada workshops |
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What You'll Learn
Clinical trial application (CTA) review and approval
Clinical trials in Canada are reviewed and approved by Health Canada (HC), which assesses clinical trial protocols, reviews drug quality, and monitors adverse drug reactions, among other responsibilities.
Clinical Trial Applications (CTAs) must be sent directly to the appropriate Directorate, with the outer label clearly stating "Clinical Trial Application". CTAs should include the following information, if known at the time of submission: the name, address, and contact information of any Research Ethics Board (REB) in Canada that has previously refused to approve the clinical trial protocol, along with the reasons for refusal and the date. Information regarding refusals by regulatory authorities outside of Canada must also be disclosed. If applicable, letters authorizing Health Canada to access related files, such as Drug Master Files or Site Reference Files, should be included.
For all biologics, the BGTD requires lot release information to be provided by the CTA sponsor/manufacturer before its use in the trial. Sponsors must also ensure that the REB Attestation and Qualified Investigator Undertaking forms have been completed and kept on file before initiating a clinical trial or implementing amendments. The Qualified Investigator Undertaking and a Research Ethics Board Attestation must be completed for each clinical trial site.
Once a CTA is submitted and reviewed, Health Canada notifies the sponsor within 30 calendar days if the application is acceptable or deficient. If the application is deemed acceptable, a No Objection Letter (NOL) is issued by Health Canada. The review process includes screening to ensure all submission components have been provided, and an acknowledgment letter is issued to the sponsor to mark the start of the review period.
If a sponsor wishes to make changes to a CTA under review, they should withdraw the active CTA and submit a new one. Records of clinical trials must be maintained by the sponsor for 25 years and made available to Health Canada within 2 days if there are concerns regarding the use of a clinical trial drug or risks to the health of the trial subjects.
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Clinical trial protocol template
Clinical trials in Canada must follow Good Clinical Practice (GCP) guidelines and comply with the country's regulatory framework for drugs and medical devices. Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) oversees clinical trials involving natural health products on human subjects.
When designing a clinical trial protocol for a drug product, sponsors should use the Protocol Safety and Efficacy Assessment Template-Clinical Trial Application (PSEAT-CTA). This template is a comprehensive document that guides sponsors through the essential elements of a clinical trial protocol, ensuring compliance with regulatory requirements. Here is a section-by-section breakdown of the critical components of the PSEAT-CTA:
Provide a concise overview of the clinical problem, including previous treatments and developments. Cite relevant preclinical and clinical pharmacology studies, therapeutic exploratory studies, and scientific literature. Introduce the new drug being investigated and justify the proposed approach or therapy. Clearly state the precise goals of the trial, including any primary and secondary objectives, such as testing a new drug population or indication.
Trial Participants and Diagnostic Criteria
Describe the specific characteristics of the trial participants, including disease stage, indication, conditions, and treatment. Outline the diagnostic criteria and assessment procedures for participant enrollment. Enumerate the conditions determining participation in the trial and provide a brief description of the study drug(s) and formulation, including any deviations from formulations used in preclinical or other clinical trials.
Trial Procedures and Schedule
Describe the schedule for using the study drug(s), including escalations, maintenance, reductions, and discontinuation. Outline the process of clinical validation for participation, including the methodology and schedule of events during the trial. Provide a detailed schedule of all events, visits, and procedures that will occur during the trial.
Drug Management and Safety
Enumerate and describe all allowed and disallowed drugs and medications, in addition to the study drugs. Outline the instructions for safe handling of the study drugs. Describe the available supportive measures, antidotes, medications, dosages, and procedures to manage any untoward effects or lack of efficacy resulting from the trial procedures. Include any potential risks associated with the drugs or procedures, such as dose dumping or immunogenicity.
Withdrawal and Discontinuation
Enumerate all conditions, criteria, and management procedures for patient withdrawal or premature discontinuation from the trial, including voluntary withdrawal by the subject. Outline the procedures for managing withdrawal and ensuring the well-being of participants.
It is important to note that this is a general overview, and specific requirements may vary depending on the nature of the clinical trial and the regulations in place at the time of the trial. Sponsors should refer to the most up-to-date guidelines provided by Health Canada and seek guidance from relevant authorities when designing their clinical trial protocols.
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Compliance trends
- Parallel Review Processes: Health Canada and REBs may conduct parallel reviews and approvals of clinical trial applications (CTAs). This allows for greater efficiency in the review process, as sponsors don't have to wait for sequential approvals. However, it emphasizes the importance of ensuring compliance with both HC and REB requirements simultaneously.
- Data Privacy and Protection: Healthcare data privacy is a critical aspect of GCP compliance in Canada. Federal laws, such as the Personal Health Information Protection Act (PHIPA) in Ontario, establish principles for handling personal health information (PHI). These laws outline practices for data security, retention, and access. Compliance with data protection legislation is essential, especially when conducting global clinical trials involving international data transfers.
- Ethical Considerations: Ethical conduct in clinical trials is a key focus for Canadian regulators. REBs play a crucial role in ensuring the ethical integrity of clinical trials. Investigators must also adhere to ethical guidelines, such as obtaining explicit consent from trial participants for accessing their medical records and personal data, particularly when conducting trials outside the EU/EEA.
- Record-Keeping and Data Accuracy: GCP compliance emphasizes careful record-keeping to ensure data accuracy and completeness. Regulations and guidelines mandate processes like investigator review, monitoring, auditing, and inspection to verify data accuracy. This includes maintaining records related to the general healthcare of study subjects before, during, and after the trial, as well as trial-specific data.
- Innovation and Flexibility: The COVID-19 pandemic has accelerated the need for flexibility and innovation in clinical trial design and conduct. Canadian regulators recognize the importance of leveraging innovative tools and approaches to enhance trial design, conduct, and inspections. This trend towards innovation aims to improve efficiency and adaptability in the face of evolving global health challenges.
- International Harmonization: Canada participates in international initiatives for harmonizing technical requirements for pharmaceuticals, such as the International Council for Harmonisation (ICH). Adopting ICH guidance documents, such as the E6(R2) Good Clinical Practice addendum, helps align Canadian regulations with international standards. This harmonization facilitates global collaboration in clinical research and ensures consistent GCP compliance across jurisdictions.
By staying abreast of these compliance trends, organizations conducting clinical trials in Canada can ensure they meet the regulatory expectations set by Health Canada and REBs, contributing to the ethical and scientific integrity of their research endeavors.
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Key topics
In Canada, Good Clinical Practice (GCP) is overseen by Health Canada (HC) and institutional ethics committees (EC) or Research Ethics Boards (REB). Clinical trials must be reviewed and approved by both HC and an EC before they can commence, and careful record-keeping is required to ensure accurate and complete data collection and reporting.
Healthcare data in Canada is protected by federal laws and provincial privacy laws, such as the Personal Health Information Protection Act (PHIPA) in Ontario, which outlines comprehensive information practices for handling personal health information (PHI).
To ensure compliance with GCP, sponsors of clinical trials are responsible for securing agreement from all involved parties to provide regulatory authorities with direct access to trial-related sites, source data, documents, and reports for inspection. Sponsors should also consider ethical implications and applicable laws and regulations, including data protection legislation.
The US, as a founding regulatory member of the International Council for Harmonisation (ICH), has adopted several ICH guidance documents, including those on good clinical practice (US-ICH-GCPs). These guidelines outline the requirements for the review of proposed clinical trials by institutional ECs within a reasonable time frame.
To further promote GCP, the FDA, MHRA, and Health Canada host workshops to provide attendees with insights into key topics, compliance trends, and lessons learned from the changing clinical trial landscape.
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Lessons learned from the changing clinical trial landscape
Canada has been a significant player in the clinical trials landscape, ranking fourth globally in terms of the number of clinical trial sites. However, the country faces challenges due to spiralling costs, conflicting requirements, and a lack of standardization. The COVID-19 pandemic has also accelerated changes and increased flexibility in clinical trial conduct.
Embracing Innovation and Flexibility:
The pandemic has highlighted the importance of adaptability in clinical trials. Canada has learned that leveraging innovative tools and approaches in trial design, conduct, and inspections can help navigate unforeseen circumstances. This includes implementing decentralized trials and flexible methods for obtaining informed consent from patients at remote sites or those unable to provide written consent.
Collaboration and Standardization:
There is a recognized need for improved cooperation among various parties involved in clinical trials in Canada. Standardization in contracts and among research ethics boards can streamline the process and reduce administrative burdens. Additionally, collaboration between industry, government, and academia is vital to maintaining Canada's competitiveness in the global market and ensuring consistent high standards.
Addressing Public Confidence and Patient Recruitment:
Canada has faced challenges in recruiting patients for clinical trials, except for trials involving cancer drugs. The public's lack of confidence in pharmaceutical companies impacts participation rates. Strategies to enhance patient engagement and involvement in the design phase, such as collaborative research, may help address this issue.
Emphasizing Safety and Peer Review:
While innovation is important, safety remains paramount. Canada's modernization initiatives emphasize a risk-based approach to oversight, ensuring proportional oversight based on the known safety information and relative risk of the products involved in a trial. Additionally, maintaining the integrity of information communicated to the public is crucial, and peer review by scientific journals plays a vital role in preventing the dissemination of incorrect information.
International Alignment and Learning from Regulators:
Most stakeholders favour aligning Canada's clinical trial regulations with international standards. However, respondents also emphasize the importance of learning from the challenges faced by other regulators. By understanding the experiences of other countries, Canada can avoid potential pitfalls and develop a robust regulatory framework.
In conclusion, Canada's clinical trial landscape is evolving, and the lessons learned from recent changes emphasize the need for flexibility, collaboration, and a patient-centric approach. By embracing innovation, addressing standardization issues, and prioritizing safety, Canada can enhance its competitiveness and contribute significantly to global clinical research advancements.
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Frequently asked questions
GCP stands for Good Clinical Practice, which is a set of international ethical, scientific, and practical standards that must be followed when conducting clinical trials.
Health Canada (HC) and institutional ethics committees (EC) or Research Ethics Boards (REB) are responsible for regulating and approving clinical trials in Canada.
Canada has federal and provincial privacy laws, including the Personal Health Information Protection Act (PHIPA) in Ontario, which outlines the collection, use, and disclosure of personal health information (PHI).
Yes, there are workshops and events, such as the FDA, MHRA, and Health Canada Good Clinical Practice Workshop, which provide insights into compliance trends, key topics, and lessons learned from experienced regulators.
