The Network of Clinical Research Networks A Canada

The Network of Clinical Research Networks: A Canada - wide Initiative Karen Arts Director Business Development Ontario Institute for Cancer Research Ma. RS Centre, South Tower, 101 College Street, Suite 500, Toronto ON Canada M 5 G 1 L 7 Founding Member and Chair Board of Directors N 2

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

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 3

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 § N 2 Proposal developed

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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

Current Membership 1. 8 Therapeutic Area Networks 2. Canadian Institutes of Health Research-Clinical Research Initiative (CIHR-CRI) 3. 16 Institutional Organizations, Centre for Applied Health Research & Evaluation, FRSQ 4. Ottawa Health Research Institute Research Ethics Web-based Education Group (“OHRI Web. Ed”) 5. And growing……. . Several additional interested groups 7

8 What is N 2’s Potential and Opportunity • 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 E 6 > 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

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) 10

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 N 2, across institutions, networks and therapeutic areas • Assistance from Canadian Institute for Health Research (CIHR) (translation)

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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 N 2 SOP Working Group via the member organization’s representative. • Training and SOP education program under development

N 2 Successes to Date • • Creation of N 2 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 N 2 meeting in collaboration with CAHO > Feb 2009 in collaboration with Society of Clinical Research Associates (So. CRA) • 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) 14

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 N 2 • Monthly Webinars relevant to clinical research areas • Exploring collaboration with industry 15

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www. n 2 canada. ca / www. r 2 canada. ca 17

18 Contact Information Ms. Karen Arts- Chair, Board of Directors Networks of Networks Office Ma. RS Centre, South Tower 101 College Street, Suite 500 Toronto ON Canada M 5 G 1 L 7 Web Site: http: //www. n 2 canada. ca/ Telephone: 416 -673 -6637 E-mail: karen. arts@oicr. on. ca Ms. Linda Bennett- Treasurer and Secretary Executive Director Canadian Rheumatology Research Consortium canadien de recherche en rhumatologie 522 University Avenue, Suite #1002 Toronto, Ontario M 5 G 1 W 7 Tel: 416 -586 -5912 Fax: 416 -586 -8395 E-mail: lbennett@mtsinai. on. ca Web site: www. rheumtrials. ca