welcome.. funders features strategy 1: establish short and longer term implementation capacity for...
TRANSCRIPT
WELCOME.
FUNDERS
FUNDERS
FEATURES
Strategy 1: Establish short and longer term implementation capacity for this action plan and coordination of other clinical trial improvement activities.
Strategy 2: Improve business operations through better cost, quality, and speed of clinical trial start up times.
Strategy 3: Shape a positive future business environment and signal Canada’s interest globally with information and incentives.
Background Executive Committee
◦ CIHR – Jane Aubin◦ Rx&D – Shurjeel Choudhri ◦ HealthCareCAN – Duncan Stewart◦ Advisory Chair – Lawrence Korngut
Executive Committee Support Team◦ CIHR – Diane Forbes, Erica Dobson◦ Rx&D – Alison Sargent, Elena Aminkova◦ HealthCareCAN – Tina Saryeddine, Claire Samuelson
Staff ◦ Director, Implementation – Belinda Vandersluis◦ Coordinator, Communications and Strategy – Leyla Di Cori
Dr. Lawrence Korngut (Chair), University of CalgaryLaura Accetola, Amgen CanadaKaren Arts, OICR, 3CTN, N2Dr. John Cairns, University British Columbia, CAHSJohn Coderre, Patient Advocate, Canadian Arthritis NetworkSharon Freitag, Ethics, St. Michael’s HospitalDr. Karen Lee, MS Society CanadaSusan Marlin, Clinical Trials OntarioDr. Robert McMaster, Vancouver Coastal Health RI, BCCRINDr. Peter Monette, Strategic Policy Branch, Health CanadaDr. Jean Rouleau, CIHR ICRHDr. Pamela Valentine, Alberta Innovates Health Solutions
National Advisory Group
Progress 2014
Strategy 1Establish short and longer term implementation capacity
Strategy 2Improve business operations
Strategy 3Signal Canada’s interest globally
Establish headquarters
Metrics, measuring performance
Infrastructure, SPOR
REB efficiencies Patient registries
and recruitment SOPs and tools Improve and use
mCTA
IP and SR&ED tax credits
CCTAM / Asset Map
Plan 2015
Strategy 1Establish short and longer term implementation capacity
Strategy 2Improve business operations
Strategy 3Signal Canada’s interest globally
• National Advisory Group engagement
• Metrics working group to measure Canada’s performance
• REB accreditation working group
• Patient registries working group
• N2 synergies• Industry
engagement and advancing mCTA
• CCTAM rollout and continued development
REC’Ms
• Operationalized in 2014, announced by Federal Minister of Health; April 2014
• Executive Committee and support team in place, meets monthly
• National Advisory Group formed n=12, meets quarterly– Dr. Lawrence Korngut, Calgary joins Executive Committee;
completed• Web and news tools at www.cctcc.ca and www.cccec.ca ;
completed
REC #1 – National Headquarters
REC’Ms
• Update 2010 Industry Benchmarking survey (Rx&D); Q2-3 2015
• Cost and start up times benchmarking w/ IMS Brogan Q1-2 2015
• First year evaluation of CCTCC; ~mid 2015– Investment in Canada $, international ranking– Short term milestones set and goals met– Future year(s) strategy and plans
REC #2 – Measure Results
REC’Ms
• Strategy for Patient Oriented Research• Funders strategic plans
REC #3 – Integrate
REC #4 – Ethics Review Efficiencies• SHRER Working Group common documents; completed. • Canadian Standards Board REB standards; completed.• Health Canada + CIHR creating an option for Canadian REB’s
to seek accreditation. *Senate Committee recommendation– CCTCC Working group ‘what would accreditation look like’; Jan-
Sept 2015
REC’Ms
REC’Ms
• Patient registries database. – Working initially to define ‘patient registry’, then develop a
database of current patient registries; potentially national meeting; developing plans for 2015
• Patient information, educational sessions for health charities and patient advocates; Q1-4 2015
REC #5 – Patient Registries and Recruitment
REC #6 – Common Tools and Site CertificationCommon Tools:•Encouraging membership in N2: SOPs, GCP Training, Common Forms and Tools
Site Certification:•Quantify ‘Clinical Trial Sites’ in Canada; working with Health Canada CTSI & inspections databases; Q1-2 2015•Future working group: Is ‘site certification’ important/valuable? 2016
REC’Ms
REC #7 – mCTA Model CT Agreement• Pilot phase completed, provincial reviews completed. mCTA available.• Current: Industry endorsement, review with ~10 companies; Feb 2015 -
>.• Next steps: Communications strategy Q2-3 2015• CRO engagement in 2015-16 (after industry review)• Future steps: development of other agreements - data sharing,
confidentiality and non disclosure, etc. 2016
REC’Ms
REC #9 – Signaling our Interest Globally• CCTAM: Canadian Clinical Trial Asset Map www.cctam.ca
– Communications packages (eng/fr) available– ‘Go Live” & rollout date June 2015
• New “Business Case” for clinical trials in Canada with DFAT Investment Services, used to engage global investors. Completed.
REC’Ms
CCTAMwww.cctam.ca |[email protected]
• Additional Slides
Addt’l
Outside of the US, Canada is top in the number of active clinical trials
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Industry Overview
Source: clinicaltrials.gov (Accessed 6 Oct 2014)
Canada has the highest number of active clinical trials per capita among G7 nations
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Industry Overview
Source: clinicaltrials.gov (Accessed 6 Oct 2014)
The majority of clinical trials are performed in ON, QC, BC and AB, but all provinces have experience in clinical trials
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*Some trials are counted multiple times when examining trials by provinceSource: clinicaltrials.gov (Accessed 6 Oct 2014)
Canadian clinicians are experienced in all major therapeutic area, and across the country
Industry Overview
Inflammation 1%
Immunology2%
Central Nervous System (CNS)
8%
Total Active Trials in Canada: 2,971
Canada has the 2nd lowest cost among G7 nations in the design, management and coordination of global clinical trials
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Source: KPMG Competitive Alternatives – Highlights (2014)
Efficient Clinical Trial Environment
The KPMG Cost Index considers a clinical trial design center:•A 10,000 sq. foot facility•50 employees•Investment in tax-eligible research
The world’s top 10 pharmaceutical companies regularly conduct clinical trials in Canada
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Source: clinicaltrials.gov (Accessed 6 Oct 2014)
Companies Choosing Canada
Canada has an efficient regulatory process that fosters the prompt setup of clinical trials
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Efficient Regulatory Review Process
• Health Canada
• Target is 30 days to review clinical trial applications1
• In 2013, Health Canada achieved their target in 99% of all applications received1
• Provinces have engaged in their own initiatives to streamline clinical trial processes for REBs
• Clinical Trials Ontario is harmonizing a streamlined research ethics review system and will implement this program in 20142
• In BC, mutual recognition of Research Ethics Boards across the BC government, University of British Columbia and BC Cancer Agency3 is streamlining the process
• Quebec has implemented new law for harmonization of reviews, Feb ‘15
Efficient Clinical Trial Environment
Sources: 1 - Health Canada website (Accessed 16 Oct 2014); 2 - Biotechnology Focus, June/July 2014 ed; 3 - Clinicall Trials and Preclinical infrastructure Asset Map. Genome British Columbia (Accessed 16 Oct 2014)
CONTACT US. WE ARE ACCESSIBLE. www.cctcc.ca [email protected] or 613-234-5678 116 Albert Street, Ottawa Ontario
Belinda Vandersluis, Director Implementation [email protected] DiCori, Communications and Strategy Coordinator [email protected] info: [email protected]
CONTACT
THANK YOU.