MaRS Centre, South Tower, 101 College Street, Suite 500, Toronto ON Canada M5G 1L7

The Network of Clinical Research Networks:A Canada - wide Initiative

Karen Arts

Director Business Development

Ontario Institute for Cancer Research

Founding Member and Chair Board of Directors N2

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Clinical Research In Canada - An environnemental scan

• Canadian Clinical Research Networks and Organizations face common challenges in their quest to be competitive in a global clinical research environment Increased regulatory demands and standards Less available funding Pressure from industry to reduce costs and improve quality Competition from developing countries

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Challenges Faced in Clinical Research

• Lack of resources• Lack of formal uniform, nationwide standards and

research best practices• Recruitment issues• Ethics, Contract and Budget challenges• Lengthy delays to start up trials• More complex research and regulatory environment• Research moving away from Canada

These result in reduced access to new and innovative treatments for patients

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History of the Initiative November 2005

Initial meeting: 23 representatives from 13 networks > Networks: challenges & successes> How to collaborate to address needs> SOP’s & GCP training (protecting human subject & assuring quality of

data)

February through May 2006 SOP working group GCP working group

June 2006 Follow-up meeting: 16 representatives from 8 networks & 4

stakeholder organizationsNovember 2006

N2 Proposal developed

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Proposal – (November 2006)Objectives

Establish an National alliance, self-governed, with “self-help” environment to share best practices, tools and resources> Initial task to create a set of investigative site SOPs and an online Good

Clinical Practice (GCP) course > Annual meeting of the networks

> discuss research-related issues > identify network needs & plan additional collaborative opportunities

Speak as a national clinical research voice and establish communication links with Health Canada, CIHR, etc. > Support the development and implementation of better national and

provincial strategies for innovation, including clinical research> Create a Canadian vision and plan

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Current Membership1. 8 Therapeutic Area Networks2. Canadian Institutes of Health Research-Clinical Research Initiative

(CIHR-CRI)3. 16 Institutional Organizations, Centre for Applied Health Research

& Evaluation, FRSQ4. Ottawa Health Research Institute Research Ethics Web-based

Education Group (“OHRI WebEd”)And growing……..Several additional interested groups

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What is N2’s Potential and Opportunity• Sharing, Sharing, Sharing• Common trends and needs allow for sharing of best

practices, tools, education and guidelines• Common expertise, experience and interests allow for

development of one common voice• Across therapeutic areas, across organizations, across

Canada• Ultimate vision:

One hub One voice Canada as a preferred research partner

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Canadian Regulatory Environment ICH E6

> 13 Principles of ICH - GCP> With regards to SOPs:Systems with procedures that assure the quality of every aspect of the trial

should be implemented.

Tri-Council Policy> Canadian Institute for Health Research (CIHR), Natural Sciences and Engineering

Research Council of Canada (NSERC), Social Sciences and Humanities Research Council of Canada (SSHRC)

> Established in 1998 and amended several times since then> A common Policy for the ethical conduct for research involving human subjects> Impacts SOP’s

Health Canada regulations, Division 5 of the Food and Drug Regulations:> Every sponsor shall ensure that a clinical trial is conducted in accordance with good

clinical practices > (c) systems and procedures that assure the quality of every aspect of the clinical

trial are implemented;

FDA CFR

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One example of resource sharing: SOPs To create a set of investigative site SOPs

> to be a national standardized set of operating procedures, >applicable to any therapeutic area. > in any given institution or research environment.

Facilitate distribution, adoption and maintenance of one standard.

SOPS need to reflect and be compliant with the regulations and guidance documents that govern clinical research

Do NOT need to be site/institution specific. Must have a mechanism in place to ensure ongoing

compliance (by way of regular expert review)

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Result• One set of national SOPs and associated tools• Complaint with Health Canada and US Food and Drug (FDA)

regulations, the ICH-GCP Guidelines and the Canadian Tri-Council Policy Statement on Research Involving Human Subjects.

• Available to all members of N2, across institutions, networks and therapeutic areas

• Assistance from Canadian Institute for Health Research (CIHR) (translation)

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Quality Maintenance• Monitor Regulatory Audit outcomes

• SOPs are externally reviewed by an independent expert annually or sooner, if dictated by changes in regulations or guidance documents.

• Comments, feedback and requests for additional SOPs or tools to be directed to the N2 SOP Working Group via the member organization’s representative.

• Training and SOP education program under development

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N2 Successes to Date• Creation of N2• National Set of Standard Operating Procedures (21 SOPs, lots of tools)• National GCP Web Based Training Program (in progress)• Web Site Development and Launch (Bilingual)

Quality Assurance Tools (SOP’s, GCP, Ethics) Information on Networks Link to Registry Information Contract information

• National Web Based Ethics in Clinical Research Training Program• Collaboration with other stakeholders• Contract Initiative Contract workshop

> Feb 22 at N2 meeting in collaboration with CAHO> Feb 2009 in collaboration with Society of Clinical Research Associates (SoCRA)

• Publications/Presentations Journal article in Applied Clinical Research, Abstracts submitted and accepted to various international conferences for

presentation in 2008• United front with respect to HC-GCP Site Fee (rapid dissemination of

information)

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Additional Projects and Partnerships underway• SOP Education Program • Annual review of SOPs• Development of National GCP Training program in

collaboration with CITI• Partnership with CIHR for additional projects• Recruitment and Retention Project,

Centre for Information and Study on Research Participation (CISCRP, http://www.ciscrp.org )

• National Budget Data base information (initiated in one of the member organizations, will be made available through N2

• Monthly Webinars relevant to clinical research areas• Exploring collaboration with industry

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www.n2canada.ca / www.r2canada.ca

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Contact InformationMs. Karen Arts- Chair, Board of Directors

Networks of Networks OfficeMaRS Centre, South Tower101 College Street, Suite 500Toronto ON Canada M5G 1L7Web Site: http://www.n2canada.ca/

Telephone: 416-673-6637E-mail: karen.arts@oicr.on.ca

Ms. Linda Bennett- Treasurer and SecretaryExecutive DirectorCanadian Rheumatology Research ConsortiumConsortium canadien de recherche en rhumatologie522 University Avenue, Suite #1002 Toronto, Ontario M5G 1W7 Tel: 416-586-5912Fax: 416-586-8395E-mail: lbennett@mtsinai.on.ca Web site: www.rheumtrials.ca