The committee therefore recommends that the federal government assume a leadership role in facilitating, coordinating and encouraging a comprehensive clinical trials infrastructure by:
- Establishing a National Framework for Coordinating Clinical Trials to; provide leadership, promote the importance of clinical trials and the benefits of being a participant, help to establish Canada as a preferred site for clinical trials, and provide a point of contact between industry and networks;
- Convening the Federal/Provincial/Territorial Conference of Health Ministers to discuss initiatives in their respective jurisdictions with a view to sharing best practices and reducing duplication of efforts; and
- Encouraging the inclusion of all relevant stakeholders in discussions, consultations and events held in respect of establishing that infrastructure.
The committee therefore recommends that the Minister of Health:
- move to immediately require clinical trial registration to the greatest degree permitted under its existing legislative and regulatory authorities;
- determine and propose the necessary amendments to the Food and Drugs Act and/or the clinical trial regulations contained in Part C, Division 5 of the Food and Drug Regulations, to require that manufacturers register a comprehensive set of data for clinical trial phases II and III on a WHO recognized website prior to recruiting any participants. Registration must include, but not be limited to, all results, adverse reactions, withdrawal of participants (non-identifying), and prematurely ended trials;
- require that all foreign clinical trials that are used to support applications for market authorizations in Canada have met equivalent registration standards; and,
- implement measures to strictly enforce this recommendation in order to ensure transparency of the clinical trial process and of the processes at Health Canada.
The committee therefore recommends that the Minister of Health direct Health Canada to immediately undertake to develop an accreditation program for Research Ethics Boards. To this end, Health Canada will, as soon as possible:
- Launch discussions, in consultation with the provinces and territories, for a national standard for Research Ethics Boards which:
- Includes all aspects of trial review including but not limited to; contracts or clinical trial agreements with parameters on compensation and fees, informed consent, placebo versus comparative effectiveness and, review of adverse reaction reports;
- can be applied to the review of all clinical trials of unapproved drugs in Canada;
- can serve as the basis for accreditation of research ethics boards, both institutionally-based and privately run; and
- Oversee the implementation of an accreditation program for research ethics review which:
- Assesses and awards accreditation to research ethics boards that review, approve and oversee clinical trials of unapproved drugs; and,
- Provides guidance on the training of those involved in research ethics boards.
The committee further recommends that the Minister of Health amend the clinical trial regulations contained in Part C, Division 5 of the Food and Drug Regulations, to stipulate that any reference to a research ethics board means an accredited research ethics board.
The committee therefore recommends that the National Framework for Coordinating Clinical Trials:
- Encourage the creation of research networks as part of its goal of promoting the importance of clinical trials; and
- Provide guidance to research networks on centralizing research ethics review and on creating databases of patients willing to be considered for clinical trials.
The committee further recommends that the Minister of Health:
- Amend the clinical trial regulations contained in Part C, Division 5 of the Food and Drug Regulations, to stipulate that clinical trials must be designed to reflect the same population that can reasonably be expected to consume the drug once approved for sale in Canada; and
- Implement modifications to its drug approval process to stipulate that market approval will only be granted if clinical trial evidence of the product’s safety and efficacy includes data on all population groups that can reasonably be expected to consume that drug once approved for sale in Canada.
The committee therefore recommends that the Minister of Health direct Health Canada to include the following elements in its Orphan Drug Framework for Canada :
- creation of ‘orphan drug status’ for drugs in development for specified rare conditions;
- assistance in the design of clinical trials for investigational orphan drugs;
- elimination or reduction of user fees charged by Health Canada to review orphan drug submissions; and,
- extension of market exclusivity for orphan drugs.
The committee further recommends that the National Framework for Coordinating Clinical Trials:
- Promote Canada as a preferred site for clinical trials of orphan drugs; and
- Include a requirement for consultations with stakeholders including the Canadian Organization for Rare Disorders to explore ways to improve and maximize patient recruitment to trials.
The committee therefore recommends that the federal government create an expert advisory committee to undertake a thorough study of the intellectual property and tax incentive issues raised by stakeholders during this study with a view to exploring options and recommending changes that will help to improve Canada’s global competitiveness in drug development.
The committee therefore recommends that the Minister of Health direct Health Canada to immediately address the recommendations made in Chapter 4 of the November 2011 Report of the Auditor General of Canada namely to:
- Strengthen the risk-based approach for monitoring and assessing clinical trial adverse reaction reports;
- Establish timelines for officially notifying clinical trial sites of non-compliant ratings; and
- Enhance public access to information on authorized clinical trials, including the results of inspections.
The committee further recommends that the Minister of Health direct Health Canada to address additional issues highlighted in the report and take immediate steps to:
- Realize the target of inspecting two percent of clinical trial sites; and
- Eliminate manual data entry of adverse drug reaction reports through full implementation of electronic reporting
The committee therefore recommends that the Minister of Health pursue the necessary changes to the Food and Drugs Act in order that the statute provide the authorities required for increased transparency, increased penalties, and other provisions critical to modernizing drug regulation in Canada.
The committee recommends that Health Canada establish the means to monitor and regularly measure the impact that implementing these recommendations has had on clinical trial activity in Canada and that it report publicly on this progress.