N2 - The Network Networks: HIV Network


Published on

Karen Arts is one of the founding members and chair of the board of directors of the Network of Networks, a not for profit organization, which aims to share best practices and establish national standards for clinical research conduct in Canada. For more info goto: http://n2canada.ca/

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

N2 - The Network Networks: HIV Network

  1. 1. The Network Networks: HIV Network April 18, 2012 Karen Arts, Chair of the Board of N2 Director Business Development OICRAdministrative Office: Lawson Health Research Institute, London Ontario
  2. 2. 2 Overview of Presentation N2’s Background Mission and Objectives Membership Committees & Deliverables Collaboration Next steps
  3. 3. 3 Current Environment: Rising Costs of Development & Pressure on R&D Budgets More complex research and regulatory environment Local issues  Rising cost and deficits  Patient Recruitment issues  Inefficient processes  Lengthy delays to start up trials  Lack of time to do the work….  Lack of formal uniform, nationwide standards and research best practices  Inadequate research support from government and institutions Silos; “we are special” phenomenon Global Competition  Research moving away from Ontario/Canada, currently at a rate of 12% per yearThese result in reduced access to new and innovative treatments for patients
  4. 4. 4
  5. 5. Health Canada Inspectorate Findings: N=360Adapted from Health Canada’s HPFB (Health Products and Food Branch) Inspectorate Report (December. 2004)
  6. 6. 6Health Canada Inspection Findings
  7. 7. The Most Common Deficiencies• Regardless of the location of the investigator site, or REB the same types of deficiencies are noted• Updated document available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli- conform/clini-pract-prat/report-rapport/2004-2011-eng.pdf• Action is required…..
  8. 8. Trends in the biopharmaceutical industry Business is becoming tougher  Research and regulation are more demanding  Wave of patent expiries by 2011  Payers looking for short-term savings - rationing access to drugs Modern drug discovery more complex  Public institutions, biopharmas, and pharmas – the “triple helix” Emerging economies successfully competing for R&D dollars  China, India, Eastern Europe, South America Clinical research – a major part of industry’s R&D investment  78% of R&D in Canada or 950M$(PMPRB)  Western governments trying to protect their share  Firms respond to cost/productivity of trials and market access
  9. 9. 9 WE ARE LOSING GROUND……Can we, and if so, how do we, as a Canadian clinical trial communitycompete in global environment?
  10. 10. Can we work in harmony?It makes sense to collaborate and to work towards common practices and harmonization where possible.Are we all “Special” ? Do we all need our own version of everythingHow to create efficiencies and streamline process? • Requires collaboration across Canada,  across stakeholders and  across therapeutic areasCan we establish a framework that allows us to work towards networking and collaboration?
  11. 11. YES, WE CAN! :• A national alliance of clinical research stakeholders with common interests• Multiple existing disease networks, institutions, universities, industry and other research stakeholders willing to join forces to enhance Canada’s research capability and capacity.• A virtual clinical research hub • self-governed, with “self-help” environment to share best practices, tools and resources)• Currently ~45 member organizations, each covering a multitude of staff. Current estimate is >3000 PIs and associated staff…… (In 2010, we had 28 organizations)
  12. 12. 12 N2 Mission & Objectives To establish an alliance of Canadian disease oriented research networks and organizations willing to join forces to facilitate and enhance Canada’s research capability and capacity To provide a self-governed, “self-help” environment for sharing of best practices, tools and resources to enable and enhance the provision of new and innovative treatments to Canadians in a timely and effective fashion
  13. 13. More Background:February through May 2006  Establish common basis and test pan- Canadian approach > SOP working group > GCP working groupJune 2006  Follow-up meeting: 16 representatives from 8 networks & 4 stakeholder organizationsNovember 2006  N2 proposal developedAugust 2007  N2 is Incorporated under the Canadian Corporations Act as a non-profit corporationFebruary 2008  First annual meeting of members (February 2008) & election first Board of Directors
  14. 14. Governance & Funding CIHR support > 2007-2008 – annual meeting and training day > Development & hosting of Web portal > Translation of SOPs & GCP materials into French > 2009 – grant to support development of CITI Canada In-kind contributions from current members > Quality materials > Working groups > Meeting planning support Membership fees New Board structure Feb 2011 > 12 members > Representational > 1 seat for Rx&D
  15. 15. 15 Current Board of DirectorsMs. Karen Arts, ChairMs. Ruth Bullas, Vice-ChairMs. Linda Bennett, Treasurer (outgoing)Mr. Patrick Clifford, Treasurer (incoming)Ms. Eric Cherban, SecretaryMr. Jim PankovichMs. Kathy Brodeur-RobbDr. Rachel SymeMs. Heather Harris-HarperMr. Jeffrey TowardDr Ray SaginurMs Farida DabouzRx&DIndispensable…..Ms Shelley KingLawson Health Research InstituteLondon Ontario
  16. 16. Aligning Efforts from the Single Stakeholder Level to the National CollaborativeLevelIndependent Stakeholders  Well-established clinical trial expertise and process Collaborations  Sites, Institutions, Sponsors (Networks; Institutions; CAHO; Rx&D, etc) Independent Trial SiteSolution #1 Come together to  Collaboration between stakeholders to address individual clinical trials issues & survive in competitive Hx: compete with other Canadian sites for trials work on common challenges environmentSolution #2 – Network of Networks  National, multi-disciplinary, multi- stakeholder group to focus on the challenges that cross indications/institutions/stakeholder groups and require a national solution Network of Networks  Can create strategic synergies and Common Challenges that collaborations leading to solutions require national solutions REB, Contracts, SOPs,  Move them back out into groups Education, Budget etc
  17. 17. Areas that cross borders and boundariesFor Example:Standard Operating Procedures (SOPs)EducationQuality InitiativesClinical Trial AgreementsCosts and budget developmentMentoringREBsAnd many more…….
  18. 18. N2 Committees• SOP Committee• Education Committee • CITI-Canada Program• Membership/Advocacy Committee• Mentoring Committee• Quality Committee• Pediatric Special Interest Committee• Recruitment Strategy/Trials Awareness Committee
  19. 19. SOPsWe know this already:• SOPs are a regulatory requirement for the conduct of clinical research at Research Institutions and Networks across Canada• Lack of or non-compliance with SOPs result in: - GCP compliance audit difficulties - Regulatory Inspection non-compliance findings• Can be used across Canada, across therapeutic areas• Having them is not optional• Great source of education
  20. 20. One of N2’s projects• 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)
  21. 21. N2 SOPsCurrently have 30 SOPs available to N2 members  ( include “regular”, IIS and eDM, Biospecimen SOPs to follow)Compliant 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 SubjectsAvailable to all members of N2, across institutions, networks and therapeutic areasFormal process for maintenance Education Program FAQs and QuizContinue to work on developing SOP’s and training tools to support conduct of clinical trial research
  22. 22. Education Committee: Collaborative Institutional Training Initiative (CITI)-Canada N2-CITI Partnership :  U of Miami > Online clinical research training – extensive program > CITI-Canada launched Aug 2010, N2-developed Canadian content > To date >1800 users > At recent CT Summit, N2 tools/programs recommended > Pfizer, Novartis, and BMS has accepted the N2-CITI Canada program; with a current CITI certificate no company GCP training required > AZ, Abbott, Astellas, Celgene, EMD Serono, reviewing > Reciprocity is the key… » Savings in time and $$
  23. 23. CITI-Canada Program, where are we at? Phase 1 • MOU N2-CITI (2009) • N2-CIHR commitment : • Allowed us to hire .5FTE in Miami • Bi-Lingual Help-desk function in place • N2 Part of the CITI-Developers group • N2 Education Committee • GCP Content Adaptation • Consultants • Timelines • Process • Initial Roll-out plan completed (to date >2200 learners have accessed and >1200 learners completed the GCP course) • Additional materials under development and being uploaded
  24. 24. CITI-Canada Program, where are we at? Phase 2 • to adjust the content for the final draft of the Tri-council Policy Statement on Research Ethics, to be accomplished with input and collaboration from stakeholders • Adaptation/Incorporation and development additional modules • Basic Biomedical • RCR • Dangerous Goods (TDG/IATA) • SPIRIT • Maintenance (ongoing) • Formal process • Canadian Developers group • Link to US • Comments review and content modification • N2 represented on global executive committee • To start exploring reciprocity with industry • Several companies have accepted CITI program as meeting GCP requirement
  25. 25. N2 - CITI-Canada: what’s next?Phase 3 • New CITI-UoM agreement, effect on Canada • Formal contract • Legal fees • Risk assessment of reliance on US • Grow program • At recent summit of decision makers, N2 recommended as catalyst for harmonization. This includes the CITI-Canada program • Ongoing discussion with Health Canada • Sustainability • To add additional programs: • RCR, Basic Biomed, TDG/IATA, Privacy, Protocol Development, Biomedical safety • Other? E.g. RECIST
  26. 26. Recruitment Strategy/Trials Awareness CommitteeDemonstrates how work at the stakeholder level (CRRC) can be pushed up and driven out through N2
  27. 27. Consequences of Diminished Trials ActivityIf clinical trials cease to come to Canada, future patient care willbe negatively impacted by reducing: • Patient access to novel therapies • Clinician early exposure to novel therapies • Clinician uptake of new therapies once in the marketplace • Canadian data in regulatory dossiers (impact on coverage) • Knowledge translation/exchange related to clinical research in Canada • Non-trial research related to patient care which is often conducted within trial infrastructure (investigator-initiated studies, registries, academic research, etc.)
  28. 28. Strategies to Improve Patient Recruitment CRRC October 23, 2010 meeting - five main areas identified toincrease recruitment: • Improving the design of clinical trials (board initiative) • Getting the right trial to the right site • Reducing administrative demands • Raising patient awareness and understanding of clinical trials • Increasing physician comfort with approaching patients (deferred; above identified as higher priority) Multi-stakeholder working groups established to developstrategies • Goals and work plans established • Implementation underway • Link to other stakeholders; N2, CISCRP
  29. 29. Raising Patient Awareness and Understanding of Clinical Trials1. Ensure potential participants have access to the info they need to understand trials & participation  Create a repository of info for the public > Disease information > Drug development; safeguards; currently approved therapies (study lay summaries); drugs currently under development > Understanding clinical trial participation; how to find a trial  Note: overarching goal is to utilize currently available materials (& link to other organizations) rather than re-invent the wheel  In partnership with other stakeholders – build a communication strategy to get the information to the public2. Support sites in their efforts to raise trial awareness locally  Create a “plug & play” tool kit for sites (brochures; posters; dvds for waiting rooms/patients to take home; web-based resource lists; publications of completed trials; thank-you letter templates, standard research info board for waiting rooms, etc.)3. Build an alliance with other stakeholders (Pharma, N2, Institutions, Networks, patient groups) to champion a national clinical trials awareness and rebranding campaign (i.e. CISCRP)
  30. 30. Where Do We Start – Pulling The Common Strategy Together• Improve recruitment into trials – meet targets on time = return on investment • Reduce the start-up timelines (expand the opportunity to recruit) • REB streamlining, contract standardization, streamline GCP training (CITI), improve trial operations management/efficiency • Enhancing the Canadian trial capacity • New site development (SOPs, training, mentoring) • Established site support (SR&ED credits) • Getting the protocol to the right sites • Refining trial designs • Improve feasibility & site selection • Engage the public • Build & execute a national trials awareness campaign and recruitment strategy • Increase patient understanding of trials so that trial discussions can occur • Broaden patient awareness of & access to clinical trials Note – green text denotes current N2-related activities.
  31. 31. N2 StrategicallyGaining significant momentumIt IS possible to build it from the ground up and capture people’s attention.We need a national voice as clinical research stakeholders: N2This will allow us to be at the table and help drive the agendaNational scene: N2 » Clinical Trial Summit, Ottawa, September 2011 » Canadian General Standards Board » CIHR: SPORProvincial scene: » BC, Alberta, Quebec » CTO in OntarioAre the starts aligning?
  32. 32. N2 Challenge Phase I: Success!!  Bottom-Up  Connect with Top-Down  Nimble  Volunteerism  Little cost Phase II • Long term strategic planning • ++ Growth • Need formal mechanism to manage growth and additional output • Sustainability • Need additional resources and infrastructure to grow • Business review completed, Survey of the membership completed • Strategic Plan under development
  33. 33. 33 N2’s Opportunity and future vision Networking, teamwork & collaborating continues At crossroads Growing rapidly, Addition of different stakeholder groups Recognition of N2’s value growing > Clinical Trial Summit Ottawa, Sep 15, 2011 Collaboration moves us toward one common voice; across therapeutic areas, across organizations, across Canada Well on our way to the ultimate vision: > Dynamic & collaborative research community > Speak to clinical research issues with one voice > Canada becomes globally competitive and a preferred research partner
  34. 34. Clinical Trial Summit 2006 - 2010 Canada’s clinical trials activity declined ~ 30%. Canada to remain competitive by overcoming operational barriers and inefficiencies, and addressing the high costs of conducting clinical trials.  Investment and opportunity in and for Canada  Impact on patients Sept 15, 2011: Canada’s first-ever National Clinical Trials Summit  Organized by the Association of Canadian Academic Hospital Organizations (ACAHO), CIHR and Rx&D  > 150 of Canada’s leading experts from academic healthcare organizations, research, governments and the private sector.  Goal: Action plan to help restore the human, social and economic benefits of clinical trials.
  35. 35. Clinical Trial Summit Areas discussed:  Globalization of Clinical Research and Metrics survey results (industry)  CIHR – Strategy for Patient Oriented Research (government)  Starting the Conversation “A SWOT, So What and Now What” – Summary, Implications and Next Steps.(Site/Academia) 5 Break-Out Sessions:  Ethics Review  Recruitment-Retention  Administrative Issues  Cost Issues  Strategic Infrastructure Issues Summary and Action Plan: in Progress  N2 submitted Request to Reader form  9 Recommendations in 3 categories
  36. 36. N2-Collaboration and Opportunities for you• YOU are member of N2• N2 jointly with stakeholders to build a strategy to enhance Canada’s competitiveness in the global clinical trials environment • Quality • Speed • Access • Deliverables• Collaborate in areas of overlap • Become active in N2 • Committees • Conference calls • Annual meeting • Your Representative
  37. 37. 38 Next Steps Discuss wishes, survey results, and N2 strategy with membership Develop 5 year strategic plan by summer 2012 BoD to collaborate to develop Business plan BoD and Committees to deliver on goals for the upcoming year Explore additional strategies and opportunities to create a well- resourced and sustainable organization > Survey results > Summit outcome > Assess alternate streams of revenue > Assess membership structure and fees Continue collaboration and communication with CIHR, Rx&D, Health Canada and other stakeholders on national projects and initiatives where feasible
  38. 38. What is key to Success?Can we harmonize? Are we really “Special”?Let’s build bridges instead of barriersShare, and collaborate like crazy!!!!!
  39. 39. 40
  40. 40. 41 Contact InformationN2 Board of DirectorsMs. Karen Arts, Chairkaren.arts@oicr.on.caN2 Administrative OfficeMs Shelley KingLawson Health Research InstituteLondon OntarioShelley.King@LawsonResearch.com
  41. 41. 42Questions or Comments???????????