Innovative Clinical Trials Initiative

In early 2015, the Government of Canada announced additional investment in SPOR beginning in April 2016. As part of its commitment to supporting clinical research and strengthening the environment for clinical trials (CT) in Canada, CIHR will be investing these new funds in an initiative that will focus on the development and implementation of innovative methods in clinical research. The SPOR innovative Clinical Trials (iCT) Initiative will contribute to increasing Canadian competitiveness in iCT research and provide a stimulus for trialists to adopt new methodologies. It will also encourage collaboration with various stakeholders, including patients, decision makers and key stakeholders involved in other elements of SPOR, such as the Networks and the SUPPORT Units.

Innovative clinical trials use designs that are alternative to traditional Randomized Controlled Trials with application in areas ranging from product development to health system improvement. iCT methods can reduce the cost of conducting trials, reduce the amount of time needed to answer research questions, and increase the relevance of research findings to patients, health care providers and policy makers. Adopting these alternative designs can maximize the use of existing knowledge and data. Some examples of iCT include:

  • Pragmatic trials;
  • Observational trials;
  • Registry-based randomized trials;
  • Cluster randomized trials;
  • Adaptive trials;
  • Trials using Bayesian methods; or
  • Small sample, biologically based trials (e.g., personalized medicine trials).

Dr. El-Gabalawy explains

To learn more, Dr. Hani El-Gabalawy, Champion for the SPOR Clinical Trials element and Scientific Director of the CIHR Institute of Musculoskeletal Health and Arthritis, discusses the ICT initiative in the podcast below.

Transcript

David Coulombe: This is David Coulombe for CIHR’s Health Research in Action News. As part of its commitment to supporting clinical research and strengthening the environment for clinical trials in Canada, CIHR will be investing new funds in an initiative that will focus on the development and implementation of innovative methods and clinical research.

To learn more about this initiative, my guest today is Dr. Hani El-Gabalawy. Scientific director of the Institute of Musculoskeletal Health and Arthritis at CIHR. Thanks for joining us, Dr. El-Gabalawy.

So what is the importance of this new initiative?

Dr. Hani El-Gabalawy: This is a new initiative from the Strategy for Patient-Oriented Research that is focused on improving the clinical trials environment in Canada. And so the initiative was launched in order to meet that unmet need.

David Coulombe: What do researchers need to know about applying for the funding opportunities under this new initiative?

Dr. Hani El-Gabalawy: Researchers need to know that this is, number one, part of the Strategy for Patient-Oriented Research, so there is a number of regulations and parameters that are used in SPOR, those being the requirement for one-to-one matching and the engagement of patients, clinicians, policy makers, other important stakeholders that are involved in the delivery of care to patients.

David Coulombe: What type of research will be funded under the initiative? And maybe you could give us some examples.

Dr. Hani El-Gabalawy: There are a number of innovative designs, clinical trial designs that are projected to be undertaken through this that may be a substitute for the large, expensive, randomized clinical trials, which are the gold standard now for showing efficacy of a certain intervention or a certain treatment.

So the trial design that’s envisaged here is pragmatic clinical trials that are based on the availability of specialized patient cohorts, clinical trial design that is based in and adaptive in nature, which means that the trial evolves with new data that is generated from the trial. The design evolves helping target perhaps smaller groups and better treatment and better dosing.

I should add that this – the design is certainly not simply based on medications, that this could be effectiveness of certain health care delivery approaches, diagnostics. So the full scope of trial design is embraced in this.

Other examples would include trial designs that are based on registries, longitudinal type of cohort studies, small biomarker-based clinical trials based on the availability of the samples that could get help guide treatment in ways that we’re not familiar with at this time.

David Coulombe: So how will the initiative benefit researchers, health care providers and, most of all, patients?

Dr. Hani El-Gabalawy: Number one, it will be addressing the need for clinical trials that are real-world and based on clinical problems that are important to address in the day-to-day practice of clinicians and in the day-to-day lives of patients.

It will hopefully bring the clinical trials closer to the point of care where they can be more easily adapted into routine clinical care. We certainly envisage that these will be less expensive and less time-consuming than the randomized clinical trials, which are, as mentioned, they’re standard right now.

So I think there’s a number of advantages for the – in terms of these innovative clinical trials that will hopefully accelerate the rate at which studies can be brought to clinical practice.

David Coulombe: Last question for you. So what are the next steps in the implementation of this initiative?

Dr. Hani El-Gabalawy: So this initiative is a multi-stage initiative. And it involves three core components, multi-year grants, Catalyst grants, and chairs. And I should add that the Catalyst grants, which are one-year grants to get the ball rolling, so to speak, do not have the one-to-one requirement for matching funding as with the other components and all the other components of SPOR.

David Coulombe: Thank you, Dr. El-Gabalawy.

Objectives

The objectives of the SPOR iCT Initiative are to:

  1. Build capacity in iCT by:
    1. Attracting Canadian clinical investigators with a focus on shifting their research programs to include innovative methodologies and adopt the principles of SPOR; and,
    2. Enhancing Canada’s capacity and expertise in innovative and cost-effective trial methodologies.
  2. Increase the intensity of iCT research nationally.

Funding opportunities

A suite of funding opportunities will be launched through the iCT Initiative with the aim to build capacity through catalyst grants, mentorship chairs, and expand the spectrum of innovative clinical trials research through ongoing multi-year grants during the initiative cycle. This investment will provide the opportunity to lever Canada’s main health resources including data collected via its accessible health care and well-developed administrative databases and further position Canadian researchers to maintain competitiveness in CT research globally.

Funding allocated through the SPOR iCT Initiative will adhere to the principles that underlie all SPOR components. These principles include a focus on projects designed to improve patient outcomes, meaningful engagement of patients, clinicians, decision makers and researchers; and a requirement for 1:1 matching of CIHR funds with non-federal government sources.

The SPOR iCT Initiative will include the following types of opportunities (additional information regarding timelines and funding can be found in each funding opportunity):

  • Catalyst Grants. These opportunities will provide seed funding for novel research perspectives. These are short-term grants to support research capacity building in iCTs in early research stages which could be useful for researchers to demonstrate sufficient potential and apply to operating grants. Applicants developing new and transformative methods relevant to iCTs, with the potential to generate high impact results, are highly encouraged to consider applying to this opportunity. Matching funds will not be required for this opportunity.
  • Mentorship Chairs. This opportunity aims to develop capacity in iCT through provision of salary and operating funds. Its intent is to attract investigators with experience/interest in iCT and patient-oriented research and will have a strong focus on mentorship.
  • Multi-Year Grants. These opportunities will allow researchers to build/develop/improve leadership and research planning. Multi-year funding is an effective way to achieve long-term goals and eliminate a lengthy start-and-stop process that can be imposed by shorter-term grants, allowing more stability and greater staff retention. As a result, researchers can continue to develop, master, and advance new methods and protocols.

SPOR iCT Initiative: Linkage Tool

Researchers and stakeholders interested in forging collaborations in relation to the SPOR Innovative Clinical Trials (iCT) Initiative may wish to complete the linkage tool survey. Note that completing this survey is not a requirement of the application process for any of the SPOR iCT funding opportunities.

By completing and submitting this survey, you are consenting to having the responses posted, uneditedFootnote 1, in a sortable table on the SPOR iCT Initiative Linkage tool survey results web page. Survey responses will be posted in the language of submission. Note that you may have your information removed at any time by sending a request to SPOR-SRAP@cihr-irsc.gc.ca. Removal should be effective as of the next update.

For the current suite of SPOR iCT funding opportunities, responses will be pulled from the survey on Friday noon (EST) and updated on the following Wednesday, until November 15, 2016. To facilitate collaborations for future launches of SPOR iCT funding opportunities, the survey tool will remain active; however, updates to the online table will only be made once new funding opportunities are launched. If you have requested that your name and information be removed and then chose to be reinstated on the list, it is your responsibility to respond to the survey again.

Should you have any questions regarding this survey or the tool, please email SPOR-SRAP@cihr-irsc.gc.ca.

Frequently Asked Questions

This series of frequently asked questions (FAQs) is meant to provide detailed information pertaining to the iCT initiative and the associated funding opportunities.

If you have any questions that are not addressed in the FAQs, please contact the CIHR Contact Center at support@cihr-irsc.gc.ca.

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