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

1. 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

2. 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

3. 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

4. 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 organizations • November 2006 • N2 Proposal developed

6. 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

7. Current Membership • 8 Therapeutic Area Networks • Canadian Institutes of Health Research-Clinical Research Initiative (CIHR-CRI) • 16 Institutional Organizations, Centre for Applied Health Research & Evaluation, FRSQ • Ottawa Health Research Institute Research Ethics Web-based Education Group (“OHRI WebEd”) • And growing……..Several additional interested groups

8. 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

9. 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

10. 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)

11. 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)

13. 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

14. 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)

15. 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

17. www.n2canada.ca / www.r2canada.ca

18. Ms. Karen Arts- Chair, Board of Directors Networks of Networks OfficeMaRS Centre, South Tower 101 College Street, Suite 500 Toronto ON Canada M5G 1L7 Web Site: http://www.n2canada.ca/ Telephone: 416-673-6637 E-mail: karen.arts@oicr.on.ca Ms. Linda Bennett- Treasurer and Secretary Executive Director Canadian Rheumatology Research Consortium Consortium canadien de recherche en rhumatologie 522 University Avenue, Suite #1002 Toronto, Ontario M5G 1W7 Tel: 416-586-5912 Fax: 416-586-8395 E-mail: lbennett@mtsinai.on.ca Web site: www.rheumtrials.ca Contact Information