Consultation - Building the future of clinical trials at the Canadian Institutes of Health Research

Introduction

The purpose of this initial consultation is to get the views of a wide array of stakeholders and partners with interests in the Canadian clinical trials ecosystem, in order to support further analysis and the development of a proposal for a long-term clinical trials strategy for CIHR.

We invite you to read the overview below, consider the consultation questions, and provide us with your responses and thoughts on any or all of these topics by December 1, 2022.

Responses should be sent to: clinicaltrials-essaiscliniques@cihr-irsc.gc.ca

Please indicate which group(s) of stakeholders and partners you represent/identify with, e.g.,

Following analysis of the comments received, CIHR will publish a "what we heard" report and will communicate on our plans for subsequent engagement.

This public consultation is voluntary, and you may choose not to participate. Responses will only be used for the purposes described herein. Please note that the information published in the "what we heard" report will not be attributed to individual respondents. If you have any questions regarding the handling of your personal information, please contact CIHR's ATIP Office at ATIP-AIPRP@cihr-irsc.gc.ca.

Background and context

The Canadian Institutes of Health Research (CIHR) is Canada's federal health research funding organization and is an independent agency which is part of the portfolio under the Minister of Health. Under the authority of the Canadian Institutes of Health Research Act, CIHR's objective is to "...excel, according to internationally-accepted standards of scientific evidence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products, and a strengthened health system." With a budget of over $1B in grants and awards annually, and working in collaboration with provinces and territories, as well as with many stakeholders and partners, CIHR funds a wide variety of programs, including research projects and researcher development. CIHR also develops policies and programs to support high quality publicly-funded research, research excellence, knowledge mobilization, and equity, diversity and inclusion in the research system.

CIHR defines a clinical trial as "a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health outcomes". While most commonly known as tests of drugs, the interventions used in clinical trials can also include studies of surgical procedures, medical devices, and healthcare system or clinical process changes. Clinical trials can vary in number and type of participant and are conducted in several phases.

The importance of well-designed clinical trials and their role in the development of effective healthcare approaches has been highlighted by the COVID-19 pandemic. With the identification of the SARS-CoV2 virus, researchers around the globe activated clinical trials to test existing drugs as potential treatments. As new vaccines and treatments were developed, these were also tested in clinical trials to confirm their safety and efficacy. Well-designed and rigorously conducted clinical trials are critical studies that support evidence-based health care.

While the private sector (e.g., pharmaceutical industry) conducts clinical trials which are required for the development of their health products, publicly-funded clinical trials can take many forms including the development of health innovations and the optimization of medical treatments. In this context, CIHR has funded many different types and sizes of clinical trials, from small phase I studies where a new drug is first used in humans, to larger trials that aim to demonstrate which medicines or interventions are most effective. Public funding can be especially important to fill in information gaps which would not normally be met by industry-sponsored research, for example, studies which compare drugs from different manufacturers, studies of off-patent medicines or surgical interventions, or studies in groups underrepresented in science.

Federal Budget 2021 announced Canada's Biomanufacturing and Life Sciences Strategy (BLSS), a $2.2 billion program which is co-led by the Ministers of Health, and of Innovation, Science and Industry. As well as investments in Canadian biomanufacturing capacity, skills training, and laboratory and research infrastructure, the BLSS provided $250M over three years for CIHR to develop and implement the Clinical Trials Fund (CTF), aimed at reinforcing Canada's clinical trials ecosystem. As well as being a component of the BLSS, the CTF is also a key part of CIHR's strategic plan priority E, supporting the integration of evidence in health decisions, such as using clinical trial results to decide on the best treatment options for individual patients.

The CTF was launched in Spring 2022, with three major streams of funding to support the development of a pan-Canadian clinical trials consortium, the training of highly-qualified personnel in all phases of clinical trial design and conduct, and the funding of individual clinical trials projects. Funding through all three streams will begin in Fall 2022.

While the CTF funding opportunities will provide some much-needed investment until the end of March 2025, the Canadian clinical trials ecosystem requires a sustained and multi-faceted response. The purpose of the current document is to seek input on how to address issues facing the Canadian clinical trials ecosystem in order to facilitate the conduct of clinical trials in Canada. The results from this initial consultation will inform next steps and further targeted engagement with stakeholders, partners and implicated communities as required.

CIHR funding for clinical trials

CIHR's broad range of funding programs provide support for an array of clinical trial projects, methods development, training and basic science that feeds into human studies. As well as funding through the open project grants, clinical trials and related projects have been supported through initiatives such as the Strategy for Patient Oriented Research's Innovative Clinical Trials Initiative.

While CIHR funding must be administered by eligible recipients or institutions, researchers may partner with other organizations, including health charities and the private sector. Roles and responsibilities of partners must be clear in order to manage real or potential conflicts of interest and to meet regulatory requirements.

  1. CIHR funding for clinical trials, consultation questions to consider:
    1. Are there gaps in CIHR's funding programs which create barriers to implementing clinical trials for researchers?
    2. Beyond conflict-of-interest considerations, what guidance is needed for stakeholders and partners to support successful partnerships under CIHR funding programs?

Innovative Clinical Trials

Through Canada's Strategy For Patient-Oriented Research (SPOR), CIHR has developed a funding stream for innovative clinical trial methods in the SPOR Innovative Clinical Trials Initiative (iCT). In addition to engaging patients and other stakeholders in the research process, SPOR-funded iCTs are expected to help reduce the high relative costs currently associated with designing and running clinical trials; provide evidence-informed improvements to the way Canadian provinces and territories make decisions about the health services they choose to offer their communities and, improve Canada's competitiveness in clinical trials, with a focus on comparative effectiveness studies and implementation science research.

  1. Innovative Clinical Trials, consultation questions to consider:
    1. How can CIHR further support the development of innovative clinical trials?
    2. Are there new areas of innovation in clinical trials that should be included in iCT initiatives?

Clinical trials within Canada's Biomanufacturing and Life Sciences Strategy

As discussed above, the Biomanufacturing and Life Sciences Strategy (BLSS) is a federal government investment with the primary objectives of growing a strong, competitive domestic life sciences sector with cutting edge biomanufacturing capabilities, and ensuring preparedness for pandemics or other health emergencies. It is anticipated that once all the various investments and funding programs under this strategy are mature, they will form a well-integrated system of support for the Canadian life sciences sector.

Under the BLSS, CIHR has launched three funding streams, aiming to support clinical trials platforms through the funding of a pan-Canadian clinical trials consortium, training platforms to support the development of the highly-qualified personnel needed to contribute to all stages of the clinical trials pipeline, and individual clinical trials projects within priority research areas. In this first stage of clinical trials projects funding, applications could be received from all trial phases and a range of designs. CIHR's funding is available until the end of March 2025.

  1. Clinical Trials within Canada's BLSS, consultation questions to consider:
    1. While a longer-term clinical trials strategy for Canada is anticipated to be broader than the current areas of focus under the Biomanufacturing and Life Sciences Strategy, should there be specific funding streams maintained to support ongoing linkages with other BLSS funding programs (such as the Canada Biomedical Research Fund and Biosciences Research Infrastructure Fund)? Are there areas where increased clinical trials support could help build Canada's biomanufacturing and life sciences sector?
    2. Are there specific trial phases that CIHR should focus on to grow Canada's biomanufacturing and life sciences sector?
    3. To date, the CTF has implemented three funding streams – a pan-Canadian clinical trials consortium, clinical trials training platforms and funding for individual clinical trials projects. Are there additional funding streams (for example, methods development, international collaboration, core outcome measures development, etc.) that would also be useful for continuing to build the domestic biomanufacturing and life sciences sector and Canadian clinical trials ecosystem?
    4. With respect to training programs, how can investigators be best supported to lead well-designed and impactful clinical trials?

The Canadian clinical trials ecosystem

Clinical trials in Canada fall under the roles and responsibilities of a number of different organizations in different jurisdictions. Regardless of whether a trial is funded by industry or other bodies, a trial that involves a new health product (including drugs (pharmaceuticals and biologics), natural health products, or medical devices), or one used outside the parameters of its market authorization, requires review by Health Canada under the Food and Drugs Act and its Regulations.

Separately, clinical trials must be reviewed and approved by research ethics boards. This can include multiple reviews and institutions, should the proposed study involve multiple sites. There are also a number of administrative processes at trial institutions and sites, for example, to establish contracts.

Funding for clinical trials can be provided by CIHR, by provincial/territorial health research organizations, by international organizations, by health charities and /or by private industry.

Other organizations also contribute to the clinical trials ecosystem, including research networks, and provincial clinical trials enabling organizations. The involvement of different agencies can vary across jurisdictions, and many jurisdictions have developed their own processes and structures which aim to support the streamlining of these various processes.

The complexity and lack of cohesion within the Canadian clinical trials ecosystem was highlighted in a report by the Standing Senate Committee on Social Affairs, Science and Technology that was released in November 2012. The committee recommended that attention be put towards bolstering the clinical trial infrastructure in Canada through enhanced leadership of the federal government, clinical trial registration and disclosure of results, standardized research ethics review, and the creation of research networks. While some progress on these issues has been made over time, and the upcoming funding of a pan-Canadian clinical trials consortium is expected to also advance work on many of these issues, there are still important considerations to address while implementing a national clinical trials strategy.

  1. Canadian Clinical Trials Ecosystem, consultation questions to consider:
    1. What barriers do researchers encounter when navigating the different steps (e.g., funding, contracts, ethics approvals) and organizations in the Canadian clinical trials ecosystem?
    2. What enabling activities or policies should CIHR establish for funded clinical trials research that would support streamlining and efficiencies in the Canadian clinical trials ecosystem?
    3. Are there practices used by other organizations that CIHR should learn from and/or form partnerships within the development of a national clinical trials strategy?
    4. What policies should CIHR consider with respect to ongoing monitoring of the status and performance of trials in order to maximize the value and impact of clinical trial research?

International models of clinical trials funding

Many countries have research funding agencies similar to CIHR which support clinical trials and research capacity development. These include the UK's National Institute for Health and Care Research (NIHR), the US National Institutes of Health, and Australia's National Health and Medical Research Council which administers the Medical Research Futures Fund.

In general, the size, structure and function of these agencies varies based on how they are situated within government and healthcare structures, but all have mechanisms to set research priorities, to allow partnerships, to support international research collaboration, and to support a range of clinical trial phases and activities.

  1. International models of clinical trials funding, consultation questions to consider:
    1. Are there specific international or multinational partnerships and practices that CIHR should leverage and learn from in the development of a national clinical trials strategy?
    2. Which mechanisms for setting clinical research priorities should CIHR learn from when planning for future funding strategies?

CIHR policies to support equity, diversity and inclusion (EDI), transparency, and research excellence

Through CIHR's funding policies, as well as Tri-Agency policies which are shared between CIHR, the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC), CIHR aims to develop program approaches which support excellence in health sciences research and support for the development of the research community.

Key policies include the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, the Tri-Agency Framework: Responsible Conduct of Research, and specifically for clinical trials, the Policy Guide – Requirements for Registration and Disclosure of Results from Clinical Trials.

Other funding requirements are aimed at increasing diversity in the health research workforce and the broad applicability of conducted research, such as through CIHR's commitments under the Action Plan: Building a healthier future for First Nations, Inuit and Métis people, and the United Nations Declaration on the Rights of Indigenous Peoples. The Tri-agency Statement on Equity, Diversity and Inclusion outlines CIHR's commitment to supporting EDI across the research enterprise.

CIHR also applies an equalization policy to some initiatives; this process ensures that the proportion of early career researchers, female Nominated Principal Investigators, and French language applications is at least equal to the proportion of applicants in those categories. This equalization approach is being applied to the Clinical Trials Fund Projects funding stream.

  1. EDI, transparency and research excellence, consultation questions to consider:
    1. Are there additional specific policies or design elements in funding opportunities that CIHR can use to further support equity, diversity and inclusion in clinical trials, including addressing barriers to clinical trial participation?
    2. How can CIHR support more effective participation of stakeholders, including people with lived/living experience, in the development of clinical trials research?
    3. How can CIHR support clinical trial results to be mobilized into evidence that can be incorporated into healthcare practice and policy?

Development of a long-term clinical trials strategy

As a result of Canada's scientific expertise, high quality healthcare system, and research funding and infrastructure, Canada is a global destination for important clinical trials. This system has been recently bolstered with the launch of CIHR's Clinical Trials Fund, which will continue to support the development of coordination infrastructure, personnel, and projects which will contribute to scientific evidence to address health problems. However, more should be done to expand this important area of research.

  1. Long-term clinical trials strategy, consultation questions to consider:
    1. Looking to the future, what key elements – in addition to funding - should a sustainable Canadian clinical trials strategy include?
    2. If CIHR could implement only one or two activities that would greatly improve the Canadian clinical trials ecosystem, which would have the greatest impact?
    3. Are there any other comments you would like to provide, or specific issues which CIHR should assess as we move ahead with our discussions on clinical trials?

Thank you for your input

Please provide your comments to clinicaltrials-essaiscliniques@cihr-irsc.gc.ca by December 1, 2022.

CIHR thanks all our stakeholders and partners for their input to this important discussion on the future of the clinical trials ecosystem in Canada. Input received will be reflected in a "what we heard" report which will be published in early 2023. Further targeted consultations on specific themes will follow.

You can keep up to date on CIHR's clinical trials projects and future opportunities to engage with us here: Clinical Trials at CIHR

Date modified: