Outsourcing

The Canadian Clinical Trials Coordinating Centre – A Unique Partnership for Promoting Canada as a Destination for Clinical Trials: Part II

Outsourcing

06:00, May 19 2017

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In Part II, Shurjeel Choudhri & Elena Aminkova, discuss initiatives taking place in Canada that boost its competitiveness on the global stage

As mentioned in Part 1 of this report, established in 2014, the Canadian Clinical Trials Coordinating Centre (CCTCC) is a unique collaboration between government – Canadian Institutes of Health Research (CIHR), industry – Innovative Medicines Canada, and health care institutions – HealthCareCAN. CCTCC's mandate is to strengthen and improve clinical trials in Canada, and promote the country as an attractive destination for clinical trials (CT).

In the past three years, the CCTCC has focused on:

  • Catalyzing and facilitating pan-Canadian collaborations for CT
  • Initiatives that will lead to faster CT start-up times
  • Promoting Canada as the ideal destination for CTs
  • Checking Canada’s CT pulse rate

The recommendation to bring Canadian CT stakeholders around the same table was made by participants in the 2011 Clinical Trial Summit and in the report of the Senate Standing Committee on Social Affairs, Science and Technology. Since November 2015, the CCTCC has brought together provincial and other pan-Canadian CT organizations to discuss trends, challenges and opportunities within the Canadian Clinical Trials environment. The purpose of these meetings is also to foster collaboration for projects that are useful for more than one province, thus avoiding duplication of effort.

Figure 1: Provincial and Pan-Canadian CT originations brought together by the CCTCC for regular meetings

The pan-Canadian expansion of the British Columbia Clinical Infrastructure Network's (BCCRIN) Clinical Trials Participation survey is a direct outcome of this initiative. The survey is unique for Canada in its nature, as it constitutes the first effort to gather invaluable insight and information from both patients who agreed to join a trial and those who declined.

CT start-up times are an area where Canada needs to be more competitive. Therefore, initiatives that will help speed up CT start-up times are a key focus for the CCTCC with four of its major projects addressing this topic. These projects include:

1) The Canadian Trials Asset Map

The Canadian Clinical Trials Asset Map (CCTAM), launched in June of 2015, is the first searchable, pan-Canadian, pan-therapeutic database showcasing the country’s clinical trial capabilities by listing investigators, clinical trial sites, hospitals, universities, clinical research organizations (CRO), SMOs, research networks, patient registries, and REBs. The CCTAM, a free database available to clinical trial sponsors in Canada and internationally, offers tremendous benefits to industry as it allows placing trials effectively and efficiently, reducing clinical trial start-up times. It also offers marketing benefits to CROs and investigators by allowing them to showcase their unique talent and expertise in conducting cutting-edge clinical trials.

Figure 2: CCTAM’s integrated mapping function allows for geolocation of listed assets

The custom-built software platform of the CCTAM is designed to keep the data up-to-date. The database functionality is continually being enhanced to serve the evolving needs of the Canadian clinical research community. CCTAM’s success has been enhanced by a number of partnerships with organizations across the country. It is a great example of success made possible by collaboration of CT stakeholders across Canada. The most recent, additions to the CCTAM are details of active Canadian patient registries.

Figure 3: CCTAM has established partnerships and collaborations with organizations across Canada

2) The Model Clinical Trial Agreement

The model Clinical Trial Agreement (mCTA) project is aimed at reducing the time needed for establishing the study contract and budget. The goal of the mCTA is to provide a standard CT contract template for Canada-wide use. The CCTCC has partnered with the CLEAR Initiative, a TransCelerate-supported project, with the goals of providing Canadian feedback to the five most contentious CT contract clauses and incorporating these clauses into the mCTA. The mCTA will be launched in the second half of 2017.

3) The Fair Value Market project

Much like the mCTA, the objective of the Fair Value Market project is to reduce the time needed for negotiating study budgets. This project will aim to establish a more efficient process and best practices while still recognizing the need to adjust the budgets by the type of health care organization involved and the geographical location of the study site.

4) Clinical Trials: The Canadian Advantage

While Canada faces challenges in the global competition for clinical trials, it offers many advantages including world-leading researchers and research institutions, high quality clinical trial data combined with the ability to perform complex clinical trials, fast regulatory approvals for clinical trial applications (CTAs), low costs compared to other G7 countries, favorable tax treatment for research and development investments, and one of the most ethnically diverse populations in the world. The CCTCC has developed an investment case titled “Clinical Trials: The Canadian Advantage,” an in-depth, concise narrative that communicates Canada's clinical trial strengths in terms of speed, quality, and incentives, as well as its unique characteristics, such as ethnically varied population with access to universal health care. This resource is already being used by many key stakeholders – pharmaceutical companies, provincial governments, Canada’s trade commissioners and federal government agencies, such as Global Affairs Canada and Innovation Science Economic Development Canada.

A Nation-wide Effort to Boost Clinical Research in Canada

Recognizing the importance of tracking Canada’s CT performance, the CCTCC has started gathering clinical trials metrics; an initiative that will provide a pulse check of Canada's CT performance overtime including a measure of the high quiality CT data being generated in Canada.

Another CCTCC initiative is based on the recommendations of the joint CCTCC and Health Canada Research Ethics Board (REB) Working Group. In 2017, CCTCC and Health Canada will work on approaches to establish a national REB leadership forum in Canada with the goals of identifying and facilitating initiatives for enhancing human research protections in Canada.

The CCTCC is not the only Canadian organization working on improving and strengthening the Canadian clinical research environment. Table 1 presents an overview of provincial organizations and their initiatives for enhancing the clinical trial environment.

Province and OrganizationGoals

Alberta - Alberta Clinical Research Consortium (ACRC), part of Alberta Innovates

Build capacity, increase efficiency and streamline the set up and conduct of clinical health research in Alberta
British Columbia - BC Clinical Research Infrastructure Network (BCCRIN), part of BC Academic Health Science Network Society (BC AHSN)Transform the clinical research and clinical trial landscape in British Columbia to enhance the province’s ability to compete in a highly competitive global marketplace for clinical research
Manitoba - RITHiM InitiativeIdentify improvement opportunities in the coordination and efficiency of research administrative and regulatory processes in Manitoba as a means to promote the province as an attractive place to invest in and undertake clinical and data intensive research
New Brunswick - Clinical Trials NB, managed by New Brunswick’s two Regional Health Authorities - Vitalite Health Network and Horizon Health NetworkProvides a rapid, flexible environment to industries to recruit patients and conduct multi-center clinical trials
Ontario - Clinical Trials Ontario (CTO)Strengthen, promote and capitalize on Ontario’s competitive advantages to conduct high-quality clinical trials
Quebec -  Early Stage Clinical Trials (ESCT) initiative developed by Montreal InVivo in process of being transferred to CQDM

Being an effective and efficient world-class reference of expertise in running early stage clinical trials and clinical proofs-of-concept.

Serve as a reference point for companies refer when they plan a clinical prefeasibility study

 

One of the most notable CT efficiencies introduced in Canada at the provincial level has been the centralization and harmonization of REBs.

Table 2 summarizes the Canadian REB centralization and harmonization efforts that have taken place over the last few years.

Province and Name of Organization/Initiatives

GoalsStatus

British Columbia – BC Ethics Harmonization Initiative (BCEHI)

Foster efficient high quality reviews, protect human research participants, and attract research to the province

It is a collaboration among the provincial health authorities and BC’s four major universities
To provide a bridge to sustainability, the Michael Smith Foundation for Health Research (MSFHR) has funded a one-year BCEHI Project Coordination function and is supporting the development of a shared technology platform
Alberta – Alberta Innovates; Alberta Health Research Ethics Harmonization (HREH)

Provide more streamlined ethics review process for health researchers, and ensure the ongoing protection of the public

Encourage multi-site research

Attract CT investment to the province & Canada

Include common application & consent form templates with guidelines and processes for multi-site approvals
The Health Research Ethics Board of Alberta (HREBA), brings together three former REBs each as a committee operating as one REB
Saskatchewan – Saskatchewan Academic Health Sciences Network (SAHSN)

Foster efficient high quality reviews, protect human research participants, and attract research to the province

The University of Saskatchewan, Universityof Regina, and the Regina Qu'Appelle Health Region (RQHR) are a part of this imitative. It reviews some clinical trial and some industry trials
Ontario – Clinical Trials Ontario (CTO); Streamlined Research Ethics Review System

Provide an infrastructure to help REBs be more efficient with multi-center CTs and attract more clinical trials to the province

One ethics review for all sites is being conducted by the REB of Record

Currently the system has 15 Qualified REBs and 77 participating sites. The system works via electronic/online submission process
Quebec – The Quebec Ministry of Health and Social Services (MSSS); MSSS Multi-Centre Research Ethics Review Mechanism

Put structure in place to relieve administrative burden while ensuring participants’ safety

One ethics review for all sites is being conducted by the REB of Record

Provides REB reviews for all institutions part of the public health care system and social services network. Universities and private clinics are excluded
Nova Scotia – Nova Scotia Health Authority; Nova Scotia Health Authority REBFoster centralized ethics review in the entire provinceHas the authority and resources to review research protocols that will be conducted within the Nova Scotia Health Authority.  The system has moved to electronic submission process
New Brunswick – New Brunswick Health Council, Research Ethics Board Horizon Health Network, and Research Ethics Board VitaliteThe health authorities in the province were amalgamated to two to increase efficiencyProvides REB reviews for all hospitals in the region by both paper and electronic means. Thirty percent of the reviews studies are industry
Newfoundland & Labrador – Health Research Ethics Board (HREB) of Newfoundland & LabradorTo capture all health research conducted in the provinceAll health research conducted in the province must go through it and has provided paperless review system since 2016

 

In addition to CCTCC, there are two other pan-Canadian initiatives that feature prominently in the Canadian clinical trials field. Canada’s Strategy for Patient-Oriented Research (SPOR), led by the Canadian Institutes of Health Research, is about ensuring that patients receive the right intervention at the right time via a coalition of federal, provincial and territorial partners. The SPOR Innovative Clinical Trials Initiative is directed towards improving the country’s competitiveness in conducting clinical trials by investing funds into development and implementation of innovative methods in clinical research.

The Network of Networks (N2) is a not-for-profit alliance of Canadian research networks and organizations working to enhance the clinical research capability and capacity in Canada. Their three strategic initiatives include:

  • Equipping clinical research professionals with the necessary tools and programs to conduct high quality research with integrity, efficiency and continuous quality improvement
  • Acting as a national voice, advocating for issues affecting or influencing clinical research in Canada
  • Leveraging the national alliance, bridging and coordinating regional and provincial initiatives

In its first four years, the CCTCC has made important progress in promoting Canada as a destination for clinical trials. The clinical trial landscape continues to change and develop. In order to respond adequately to the environmental conditions, a strategic consultation and related activities are being undertaken to determine the role a pan-Canadian clinical trial coordinating organization could play in the future.

 

Shurjeel H Choudhri

Senior Vice President and Head, Medical and Scientific Affairs

Bayer Inc.

 

Elena Aminkova

Interim Director of Project Facilitation

Canadian Clinical Trials Coordinating Centre

 

References

1) The Senate Standing Committee on Social Affairs, Science and Technology, chaired by Senator Kelvin Ogilvie, published its report, Canada’s Clinical Trial Infrastructure: A prescription for Improved Access to New Medicines – https://sencanada.ca/content/sen/committee/411/soci/dpk/01nov12/home-e.htm

2) An Overview of Research Ethics Harmonization in Canada, 2012, Strategy for Patient-Oriented Research Streamlining of Health Research Ethics Review External Advisory Committee

3) Report on the Canadian experience of Research Ethics Boards (REBs) harmonization and centralization

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