Embed Size (px)
Citation preview
Developing a Canadian Clinical Research
Asset Map
Shurjeel H Choudhri MD, FRCPC
Senior Vice President & Head, Bayer Inc
Clinical Research: Canada is losing its edge
Cost/Performance (value for money)
Operational environment (public/private partnerships)
Recruitment Reliability (lost opportunity)
Canada’s Competitiveness
Clinical Trials by Country: Percent Change from 2005 to 2010
-20%
0%
20%
40%
60%
80%
100%
120%
140%
160%
180%
1 2
3 4 5 6 7 8 9 10 11 12 13 14 15
16
Perc
enta
ge o
f Cha
nge
Country by Rank from 1 to 16
Japan
China
Russian Confederation
Poland
Australia
Argentina
Germany
France
Brazil
India
CANADA
Clinical Trial Sites by Country: Percent Change from 2005 to 2010
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
16 -50%
0%
50%
100%
150%
200%
250%
Perc
enta
ge o
f Cha
nge
Country by Rank 1 to 16
Japan
India
China
Russian Confederation
Argentina
Poland
Brazil
Australia
South Africa
United Kingdom
Spain
France
CANADA
1 2 3 4 5
6 7 8 9 10 11 12 13 14 15 16
-100%
-50%
0%
50%
100%
150%
200%
250%
300%
Perc
enta
ge o
f Cha
nge
Country by Rank from 1 to 16
India
Japan
China
Spain
Russian Confederation
Brazil
United States of America
Australia
Poland
France
Germany
Argentina
CANADA
Clinical Trial Subjects by Country: Percent Change from 2005 to 2010
Average Recruitment Reliability (AvRR): From 2005 to 2010
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
2005 2006 2007 2008 2009 2010
AvR
R
Year
Canada
Global
Per-‐Patient Cost by Country: 2006 to 2010
0
5,000
10,000
15,000
20,000
25,000
2006 2007 2008 2009 2010
Per-
Patie
nt C
ost (
CA
N$)
Year
Canada
France
Germany
Spain
United Kingdom
United States
CANADA
CANADA
$0 $5,000 $10,000 $15,000 $20,000 $25,000
Canada France
Canada Germany
Canada Spain
Canada United Kingdom
Canada United States
Per-Patient Cost (CAN$)
Com
paris
on C
ount
ry
Per-‐Patient Cost: International Comparators
Time to First Patient In (FPI) by Year
0
50
100
150
200
250
2005 2008 2010
Tim
e to
FPI
(DAY
S)
Year
Canada
United States of America
Global
• 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
….but we are still in the game
• The first ever clinical trial steering committee meeting on September 15, 2011
• 150 experts from Government, Academia, Clinical Sites and Industry
• The Summit addressed topics of critical importance to the Canadian 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
5-10 years?
Clinical Trials Summit 2011
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
Strategy 1: Establish short & longer term implementation capacity for this action plan & coordination of other CT 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 & signal Canada’s interest globally with information& incentives.
Recommendation Details Recommendation Details Recommendation Details
Recommendation 1. Establish an implementation headquarters & resources to implement action plan & to coordinate existing clinical trial improvement activity.
Coordination & implementation focus & resource are required as is coordination of existing CT initiatives. SPOR to be approached.
Recommendation 4. Improve efficiencies of ethics reviews-common forms and metrics and advance strategic considerations like accreditation & harmonization.
Leveraging appropriate expertise, common consent & ethics application forms will be developed to reduce confusion and cost. It will begin with feasibility & option assessment. Strategic issues like accreditation also require detailing.
Recommendation 8. Optimize intellectual property protection policy & SR&ED Tax Credits
We can improve the attractiveness of Canada as an investment partner by adjusting IP and SR&ED policy.
Recommendation 2. Measure, monitor, manage and market CT performance improvements
As the intent of the plan is to attract business, results need to be measured & communicated.
Recommendation 5. Develop a database of registries to identify eligible patients & consider national recruitment strategy.
Using appropriate privacy considerations, improve recruitment by focussing on the use of registries & a national recruitment strategy.
Recommendation 9. Signal our interest globally - open a concierge (storefront) service for investors
Beginning on a small scale, communicate CT assets & improvements to global companies. Consider concierge or storefront for investors.
Recommendation 3. Integrate health system and research infrastructure to address issues which affect CTs because of the impact on research and healthcare.
A bold long term vision is needed for issues impacting health care & research & thereby CTs. This will enable cost containment considerations and sustainability.
Recommendation 6. Adopt common SOPs, training and certification that are already available.
Resources will be sought for broader use of N2’s common SOPs, training & certification to increase trust & efficiency.
Recommendation 7. Improve and use the model clinical trials contract (mCTA)
Upon pilot completion, adjust the mCTA as needed & communicate use to global offices.
Full action plan: ACAHO, Rx&D, CIHR, 2012. To Your Health & Prosperity…An action plan to help attract more clinical trials to Canada. See: www.acaho.org or www.canadapharma.org
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.
To Your Health & Prosperity…An Action Plan to help attract more clinical trials to Canada
Strategy 1: Establish short & longer term implementation capacity for this action plan & coordination of other CT 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 & signal Canada’s interest globally with information& incentives.
Recommendation Details Recommendation Details Recommendation Details
Recommendation 1. Establish an implementation headquarters & resources to implement action plan & to coordinate existing clinical trial improvement activity.
Coordination & implementation focus & resource are required as is coordination of existing CT initiatives. SPOR to be approached.
Recommendation 4. Improve efficiencies of ethics reviews-common forms and metrics and advance strategic considerations like accreditation & harmonization.
Leveraging appropriate expertise, common consent & ethics application forms will be developed to reduce confusion and cost. It will begin with feasibility & option assessment. Strategic issues like accreditation also require detailing.
Recommendation 8. Optimize intellectual property protection policy & SR&ED Tax Credits
We can improve the attractiveness of Canada as an investment partner by adjusting IP and SR&ED policy.
Recommendation 2. Measure, monitor, manage and market CT performance improvements
As the intent of the plan is to attract business, results need to be measured & communicated.
Recommendation 5. Develop a database of registries to identify eligible patients & consider national recruitment strategy.
Using appropriate privacy considerations, improve recruitment by focussing on the use of registries & a national recruitment strategy.
Recommendation 9. Signal our interest globally - open a concierge (storefront) service for investors
Beginning on a small scale, communicate CT assets & improvements to global companies. Consider concierge or storefront for investors.
Recommendation 3. Integrate health system and research infrastructure to address issues which affect CTs because of the impact on research and healthcare.
A bold long term vision is needed for issues impacting health care & research & thereby CTs. This will enable cost containment considerations and sustainability.
Recommendation 6. Adopt common SOPs, training and certification that are already available.
Resources will be sought for broader use of N2’s common SOPs, training & certification to increase trust & efficiency.
Recommendation 7. Improve and use the model clinical trials contract (mCTA)
Upon pilot completion, adjust the mCTA as needed & communicate use to global offices.
Full action plan: ACAHO, Rx&D, CIHR, 2012. To Your Health & Prosperity…An action plan to help attract more clinical trials to Canada. See: www.acaho.org or www.canadapharma.org
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.
Recommendation 9. Signal our interest globally - open a concierge (storefront) service for investors
Beginning on a small scale, communicate CT assets & improvements to global companies. Consider concierge or storefront for investors.
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.
What is the Canadian Clinical Trials Asset 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.
Canadian Clinical Trials Asset Map Objectives
� 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.
Current Status
Value of Clinical Trial Investment = Costs (procedural + IRB + start-up + overhead + lost opportunity + complexity – SR&ED credits) + Quality + Efficiency (regulatory approval timelines + speed of establishing contract + IRB approval + trial complexity + trial initiation + enrollment)
Asset Map Working Group Members Alison Orth BCCRIN, Clinical Research Consultant, Barbara Nicholls GSK Bradley Millson Foreign Affairs & Intl Trade Canada Celia Lourenco Health Canada, Office of Clinical Trials Christophe Ledent Industry Canada Farida Dabouz FB2D Clinical Research Consulting Geoffrey Hynes CIHR Heather Dunster Rx&D Heather Harris BCCRIN Janette Panhuis Population Health Research Institute Joanna O'Reilly Health Canada, Office of Clinical Trials Karen Arts Ontario Institute of Cancer Research Keith Francis Bayer Ken Hughes Rx&D Linda Assouline Abbott Linda Bennett Cdn Rheumatology Research Consortium Marielle Métrailler Rx&D Mark Ferdinand Rx&D Muhammad Mamdani St. Michaels Hospital - Li Ka Shing Knowledge Institute Nadia Lise Tanel Bloorview Research Insitute, Holland Bloorview Kids Rehab Hospital Natasha Georgijev EMD Serono Rohinish Gunadasa Syreon Corporation Ron Heslegrave CT Ontario Sandra Gazel Abbott Shurjeel Choudhri Bayer Tina Saryeddine ACAHO
Thanks!
Questions?
