Draft guidance on the registration of clinical trials and public disclosure of results: Overview

On this page

• Purpose
• Scope and application
• Policy objectives
• Policy statements
• Background
• Note on guidance documents in general

Purpose

Health Canada is the federal regulator responsible for the regulation of clinical trials involving a wide range of products, including:

• drugs that are:
  • biologic
  • pharmaceutical
  • radiopharmaceutical
• medical devices
• natural health products (NHPs)

Clinical trials are an important step in health product development. They are essential for the development of new treatment options and support early and safe access to health innovations.

Increasing transparency around clinical trials facilitates public access to clinical trial information. It can also result in improved recruitment by informing interested persons about trials that are taking place. This includes those who identify with population groups that are often underrepresented in clinical trials, such as:

• women
• Indigenous Peoples
• ethnic and racialized groups

Increased transparency can also increase public trust and confidence in the safety and efficacy of health products, and inform where further research is needed.

Scope and application

Currently, Health Canada authorizes the sale and importation of drugs, medical devices and NHPs for the purpose of conducting clinical trials or investigational testing involving human participants.

In addition, Health Canada introduced regulations authorizing the:

• sale and importation of COVID-19 drugs and medical devices for the purposes of a clinical trial
• conduct of clinical trials for COVID-19 drugs and medical devices in response to the COVID-19 pandemic

A Letter of Authorization is issued for medical devices, and a Notice of Authorization is issued for NHPs if all regulatory requirements have been met in the trial application. No authorization is issued for clinical trials investigating drugs, as the regulations give Health Canada the authority to object to a trial that does not meet regulatory requirements, rather than authorizing one that does. Drug trial applications meeting regulatory requirements are issued a No Objection Letter (NOL).

For the purpose of this guidance, the term "authorized" will be used to describe trials that have received:

• a No Objection Letter
• a Letter or Notice of Authorization or
• a clinical trial authorization for a COVID-19 related drug or medical device

The term "sponsors" will refer to:

• authorization holders for investigational testing under the Medical Devices Regulations (MDR)
• sponsors of a clinical trial under the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR)

This guidance document applies to all sponsors with authorization to sell or import a health product for the purpose of a clinical trial. It also applies to sponsors with authorization to conduct a COVID-19 drug or medical device clinical trial involving human participants in Canada, as specified below:

• Health Canada-authorized clinical trials investigating drugs (including pharmaceuticals, biologics and radiopharmaceuticals), medical devices, and NHPs, with the exception of trials involving a single individual
• Including:
• Classes 2 to 4 medical device studies
• Phases 1 through 3 of NHP development
• Phases 1 through 3 of drug development and comparative bioavailability studies
• For marketed products where the authorized trial involves use of a product outside the parameters of the Notice of Compliance (NOC) for drugs, Medical Device Licence for medical devices or Product Licence for NHPs
• For example, part of a commitment made for an NOC issued under the Notice of Compliance with conditions (NOC/c) policy or mandated by terms and conditions

Policy objectives

To provide guidance to sponsors of Health Canada-authorized clinical trials to support the registration and public disclosure of results (reporting of results) using international registries.

Additionally, this document describes the clinical trial information that Health Canada is publishing on the Health Canada Clinical Trials Portal.

Policy statements

This policy aims to improve public access to information about clinical trials in Canada by addressing elements relating to:

• registration
• reporting of results
• access

Canadian sponsors should register their Health Canada-authorized clinical trials before recruitment of the first participant. This should be done in accordance with requirements of a clinical trial registry that complies with World Health Organization (WHO) standards.

Sponsors should submit the summary results of their Health Canada-authorized clinical trials to a clinical trial registry that complies with WHO standards. This will be the same registry where the sponsor first registered the trial. The information included in the summary results is considered summary information and does not include individual patient data.

Sponsors should submit the results of their clinical trial within 12 months following primary study completion. Primary study completion means the final study visit for collection of data on the primary outcome for the last trial participant.

Background

Health Canada is advancing the modernization of its clinical trial regulations to better serve stakeholders, while continuing to protect the safety of clinical trial participants.

Health Canada conducted consultations on the proposed clinical trials modernization initiative. The feedback we received supports mandatory registration and reporting of results, with the strongest support for requirements that are aligned internationally.

Health Canada is positioned to move towards regulating clinical trial transparency with:

• this stakeholder support
• established international standards
• the clinical trial authorities which came into force under the Food and Drugs Act (FDA) on May 23, 2020

As a preparatory step, this policy gives stakeholders the opportunity to develop or augment existing practices associated with registration and reporting of results before regulations are proposed in Canada.

Food and Drugs Act c. 29, s. 166, paragraph 3.3

Note on guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Heath Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us assess the safety, efficacy, or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.