Developing a Canadian  Clinical Research      Asset Map     Shurjeel H Choudhri MD, FRCPC    Senior Vice President & Head,...
Clinical Research:Canada is losing its edgeCost/Performance                             Operational environment(value for ...
Clinical	  Trials	  by	  Country:	  	                Percent	  Change	  from	  2005	  to	  2010	                         1...
Clinical	  Trial	  Sites	  by	  Country:	  	                         Percent	  Change	  from	  2005	  to	  2010	          ...
Clinical	  Trial	  Subjects	  by	  Country:	  	                          Percent	  Change	  from	  2005	  to	  2010	      ...
Average	  Recruitment	  Reliability	  (AvRR):	         From	  2005	  to	  2010	         1.6       1.4       1.2        1Av...
Per-­‐Patient	  Cost	  by	  Country:	  	                            2006	  to	  2010	                            25,000   ...
Per-­‐Patient	  Cost:	  	                            International	  Comparators	                           Canada        ...
Time	  to	  First	  Patient	  In	  (FPI)	  by	  Year	                       250                     200Time to FPI (DAYS) ...
….but	  we	  are	  still	  in	  the	  game	  •  Well-characterized and well managed patient population•  We must compete g...
Clinical	  Trials	  Summit	  2011	  •  The first ever clinical trial steering committee meeting onSeptember 15, 2011•  150...
Clinical	  Trials	  Action	  Plan	                                             http://www.acaho.org/?policy_2012
To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada        The Vision is for Canada ...
To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada        The Vision is for Canada ...
Why Create a New Asset Map?Limitations of existing asset maps include:—  Most are promotional brochures and represent onl...
What is the Canadian Clinical TrialsAsset Map?—  Inspired by the Clinical Trials Summit Action Plan—  Project to develop...
Canadian Clinical Trials Asset MapObjectives—  Improve capacity for both academic and  commercial sectors to conduct clin...
Current Status
Value of Clinical Trial Investment =Costs (procedural + IRB + start-up + overhead + lostopportunity + complexity – SR&ED c...
Asset Map Working Group MembersAlison Orth           BCCRIN, Clinical Research Consultant,Barbara Nicholls      GSKBradley...
Thanks!	      	  Questions?	  
Developing a Canadian Clinical Research Asset Map - Shurjeel H. Choudhri
Developing a Canadian Clinical Research Asset Map - Shurjeel H. Choudhri
Developing a Canadian Clinical Research Asset Map - Shurjeel H. Choudhri
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Developing a Canadian Clinical Research Asset Map - Shurjeel H. Choudhri

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Developing a Canadian Clinical Research Asset Map - Shurjeel H. Choudhri

  1. 1. Developing a Canadian Clinical Research Asset Map Shurjeel H Choudhri MD, FRCPC Senior Vice President & Head, Bayer Inc
  2. 2. Clinical Research:Canada is losing its edgeCost/Performance Operational environment(value for money) (public/private partnerships) Canada’s Competitiveness Recruitment Reliability (lost opportunity)
  3. 3. Clinical  Trials  by  Country:     Percent  Change  from  2005  to  2010   180% Japan 160% China 140%Percentage of Change Russian Confederation 120% Poland 100% Australia 80% CANADA 60% Argentina 40% Germany 20% France 0% 3 4 5 6 7 8 9 10 11 12 13 2 14 15 16 Brazil -20% 1 India Country by Rank from 1 to 16
  4. 4. Clinical  Trial  Sites  by  Country:     Percent  Change  from  2005  to  2010   250% Japan 200% IndiaPercentage of Change China 150% Russian Confederation Argentina 100% Poland Brazil 50% CANADA Australia South Africa 0% 5 6 7 8 4 1 2 3 United Kingdom 9 10 11 12 13 14 15 16 Spain -50% France Country by Rank 1 to 16
  5. 5. Clinical  Trial  Subjects  by  Country:     Percent  Change  from  2005  to  2010   300% India 250% JapanPercentage of Change 200% China Spain 150% Russian Confederation 100% Brazil 50% CANADA United States of America Australia 0% 4 5 1 2 3 6 7 8 9 Poland 10 11 12 13 14 15 16 -50% France Germany -100% Argentina Country by Rank from 1 to 16
  6. 6. Average  Recruitment  Reliability  (AvRR):   From  2005  to  2010   1.6 1.4 1.2 1AvRR 0.8 Canada 0.6 Global 0.4 0.2 0 2005 2006 2007 2008 2009 2010 Year
  7. 7. Per-­‐Patient  Cost  by  Country:     2006  to  2010   25,000 CANADA CANADAPer-Patient Cost (CAN$) 20,000 15,000 Canada France 10,000 Germany Spain 5,000 United Kingdom United States 0 2006 2007 2008 2009 2010 Year
  8. 8. Per-­‐Patient  Cost:     International  Comparators   Canada United StatesComparison Country Canada United Kingdom Canada Spain Canada Germany Canada France $0 $5,000 $10,000 $15,000 $20,000 $25,000 Per-Patient Cost (CAN$)
  9. 9. Time  to  First  Patient  In  (FPI)  by  Year   250 200Time to FPI (DAYS) 150 Canada 100 United States of America Global 50 0 2005 2008 2010 Year
  10. 10. ….but  we  are  still  in  the  game  •  Well-characterized and well managed patient population•  We must compete globally •  Understand the global clinical research landscape •  Understand our patient population (strategic choices) •  Create research infrastructure for trials of the future •  Be fast, efficient and reliable (get results) •  Create a favorable business environment (IP-Access-Price) •  Innovation Strategy/Knowledge Based Economy
  11. 11. Clinical  Trials  Summit  2011  •  The first ever clinical trial steering committee meeting onSeptember 15, 2011•  150 experts from Government, Academia, Clinical Sites andIndustry•  The Summit addressed topics of critical importance to theCanadian clinical trial environment, including: •  Ethics review process •  Recruitment, patient retention and follow-up (administrative databases, e- records) •  Cost structure •  Administrative (contracts, standard operating procedures, education, training) •  Future – what strengths can Canada develop that would make a difference in
  12. 12. Clinical  Trials  Action  Plan   http://www.acaho.org/?policy_2012
  13. 13. To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada The Vision is for Canada to become a premier country globally for conducting industry led clinical trials (CTs)  The Goals are to help (1) reverse or halt a downward CT investment trend; (2) improve business operations; (3) create a positive forward looking opportunity.Strategy 1: Establish short & longer term Strategy 2: Improve business operations through better Strategy 3: Shape a positive future businessimplementation capacity for this action plan & cost, quality, and speed of clinical trial start up times. environment & signal Canada’s interestcoordination of other CT improvement activities globally with information& incentives. Recommendation Details Recommendation Details Recommendation DetailsRecommendation 1. Establish Coordination & Recommendation 4. Leveraging appropriate Recommendation 8. We can improve thean implementation implementation focus & Improve efficiencies of ethics expertise, common consent & Optimize intellectual attractiveness ofheadquarters & resources to resource are required as reviews-common forms and ethics application property protection policy Canada as animplement action plan & to is coordination of metrics and advance forms will be developed to & SR&ED Tax Credits investment partnercoordinate existing clinical existing CT initiatives. strategic considerations like reduce confusion and cost. It will by adjusting IP andtrial improvement activity. SPOR to be accreditation & begin with feasibility & option SR&ED policy. approached. harmonization. assessment. Strategic issues like accreditation also require detailing.Recommendation 2. As the intent of the plan Recommendation 5. Using appropriate privacy Recommendation 9. Beginning on a smallMeasure, monitor, manage is to attract business, Develop a database of considerations, improve Signal our interest globally scale, communicateand market CT performance results need to be registries to identify eligible recruitment by focussing on the - open a concierge CT assets &improvements measured & patients & consider national use of registries & a national (storefront) service for improvements to communicated. recruitment strategy. recruitment strategy. investors global companies. Consider conciergeRecommendation 3. A bold long term vision Recommendation 6. Adopt Resources will be sought for orIntegrate health system and is needed for issues common SOPs, training and broader use of N2’s common storefront forresearch infrastructure to impacting health care certification that are already SOPs, training & certification to investors.address issues which affect & research & thereby available. increase trust & efficiency.CTs because of the impact CTs. This will enable coston research and healthcare. containment Recommendation 7. Upon pilot completion, adjust Full action plan: ACAHO, Rx&D, CIHR, 2012. To considerations and Improve and use the model the mCTA as needed & Your Health & Prosperity…An action plan to help sustainability. clinical trials contract (mCTA) communicate use to global attract more clinical trials to Canada. See: offices. www.acaho.org or www.canadapharma.org
  14. 14. To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada The Vision is for Canada to become a premier country globally for conducting industry led clinical trials (CTs)  The Goals are to help (1) reverse or halt a downward CT investment trend; (2) improve business operations; (3) create a positive forward looking opportunity.Strategy 1: Establish short & longer term Strategy 2: Improve business operations through better Strategy 3: Shape a positive future businessimplementation capacity for this action plan & cost, quality, and speed of clinical trial start up times. environment & signal Canada’s interest Recommendation 9.coordination of other CT improvement activities Beginning on a globally with information& incentives. Recommendation Signal our interest Details Recommendation small Details scale, Recommendation Details implementation focus - open a globally & Improve efficiencies of ethics communicate CT intellectualRecommendation 1. Establish Coordination & Recommendation 4. Leveraging appropriate Recommendation 8. We can improve thean implementation expertise, common consent & Optimize attractiveness ofheadquarters & resources toimplement action plan & to concierge metrics and advance is coordination of (storefront) resource are required as reviews-common forms and assets & ethics application forms will be developed to property protection policy & SR&ED Tax Credits Canada as an investment partnercoordinate existing clinical existing CT initiatives. strategic considerations like reduce confusion and cost. It will by adjusting IP andtrial improvement activity. service for accreditation & SPOR to be approached. investors harmonization. improvements to begin with feasibility & option assessment. Strategic issues like SR&ED policy. global companies. accreditation also require detailing. Consider considerations, improve or conciergeRecommendation 2. As the intent of the plan Recommendation 5. Using appropriate privacy Recommendation 9. Beginning on a smallMeasure, monitor, manage is to attract business, Develop a database of Signal our interest globally scale, communicateand market CT performance results need to be registries to identify eligible recruitment by focussing on the - open a concierge CT assets &improvements measured & communicated. patients & consider national recruitment strategy. storefront for use of registries & a national recruitment strategy. (storefront) service for investors improvements to global companies.Recommendation 3. A bold long term vision Recommendation 6. Adopt investors. for Resources will be sought Consider concierge orIntegrate health system and is needed for issues common SOPs, training and broader use of N2’s common storefront forresearch infrastructure to impacting health care certification that are already SOPs, training & certification to investors.address issues which affect & research & thereby available. increase trust & efficiency.CTs because of the impact CTs. This will enable coston research and healthcare. containment Recommendation 7. Upon pilot completion, adjust Full action plan: ACAHO, Rx&D, CIHR, 2012. To considerations and Improve and use the model the mCTA as needed & Your Health & Prosperity…An action plan to help sustainability. clinical trials contract (mCTA) communicate use to global attract more clinical trials to Canada. See: offices. www.acaho.org or www.canadapharma.org
  15. 15. Why Create a New Asset Map?Limitations of existing asset maps include:—  Most are promotional brochures and represent only a snapshot of clinical research in a particular region, disease area or time period—  Focus is on academic or institutional sites with a gap in information for private, non-institutional research sites—  Information available is of variable age with some being current while many others appear not to have been updated frequently, being up to 5 years old.—  Highly variable content with some asset maps providing very general information and others being specific.
  16. 16. What is the Canadian Clinical TrialsAsset Map?—  Inspired by the Clinical Trials Summit Action Plan—  Project to develop a web-based, “living”, easily searchable, interactive, database of Canadian clinical research capabilities—  Broad umbrella of working group members from Rx&D and member companies, CIHR, DFAIT, HC, IC, ACAHO, BCCRIN, CTO, N2, etc.
  17. 17. Canadian Clinical Trials Asset MapObjectives—  Improve capacity for both academic and commercial sectors to conduct clinical studies in Canada;—  Position Canada globally as an attractive destination for clinical trial investments.
  18. 18. Current Status
  19. 19. Value of Clinical Trial Investment =Costs (procedural + IRB + start-up + overhead + lostopportunity + complexity – SR&ED credits) +Quality +Efficiency (regulatory approval timelines + speed ofestablishing contract + IRB approval + trial complexity +trial initiation + enrollment)
  20. 20. Asset Map Working Group MembersAlison Orth BCCRIN, Clinical Research Consultant,Barbara Nicholls GSKBradley Millson Foreign Affairs & Intl Trade CanadaCelia Lourenco Health Canada, Office of Clinical TrialsChristophe Ledent Industry CanadaFarida Dabouz FB2D Clinical Research ConsultingGeoffrey Hynes CIHRHeather Dunster Rx&DHeather Harris BCCRINJanette Panhuis Population Health Research InstituteJoanna OReilly Health Canada, Office of Clinical TrialsKaren Arts Ontario Institute of Cancer ResearchKeith Francis BayerKen Hughes Rx&DLinda Assouline AbbottLinda Bennett Cdn Rheumatology Research ConsortiumMarielle Métrailler Rx&DMark Ferdinand Rx&DMuhammad Mamdani St. Michaels Hospital - Li Ka Shing Knowledge InstituteNadia Lise Tanel Bloorview Research Insitute, Holland Bloorview Kids Rehab HospitalNatasha Georgijev EMD SeronoRohinish Gunadasa Syreon CorporationRon Heslegrave CT OntarioSandra Gazel AbbottShurjeel Choudhri BayerTina Saryeddine ACAHO
  21. 21. Thanks!    Questions?  
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