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Agenda CCTCC & Provincial Clinical Trial Organizations’ Meeting
Friday, April 1, 2016 – 11:00 am to 3:00 pm EST Lord Elgin Hotel, 100 Elgin St., Lady Elgin Room
Toll Free: +1 888-506-2534 | Participant PIN Code: 900 488 32
Item Agenda Item Lead Time
1. Welcome and introductory remarks.
Moderator (Susan Marlin) & Elena Aminkova
11:00 - 11:10
2. Introductions. Moderator (Susan Marlin) 11:10 - 11:20
3. Ongoing projects and initiatives to raise awareness of, promote or find collaboration for:
Elena Aminkova & Alison Sargent
11:20 –12:00
a.) CCTCC -Marketing Canada as a go-to-destination for clinical trials at BIO 2016
b.) CCTAM - help with increasing awareness & data collection
Elena Aminkova
12:00-12:30
c.) CCTCC mCTA - collaboration for its implementation & uptake
d.) CCTCC Fair Market Value (FMV) Working Group (WG) - call for WG member nominations
Message from the CCTCC Presidents’ Committee Russell Williams, Chair of the CCTCC Presidents’ Committee
12:30-12:40
LUNCH BREAK 12:40-1:10
e.) CTO's Streamlined Research Ethics Review System - pilot outside Ontario
Susan Marlin
1:10 - 1:40
f.) BCCRIN's Clinical Research Engagement Initiatives:
• BCCRIN (now national) Clinical Trial Participation Survey - update
• BCCRIN's Permission To Contact (PTC)
demonstration project with the BC SPOR Support Unit - discussion
Heather Harris
1:40 - 2:10
4. Round-table updates. All
2:10 - 2:40
5. Other Business: • New investigator training
Shurjeel Choudhri/ all
2:40 - 2:55
6. Adjournment & Next Meeting. Moderator (Susan Marlin) 2:55 - 3:00
WELCOME
Welcome to the CCTCC & Provincial Clinical Trials
Organizations’ Meeting April 1, 2016
www.cctam.ca |[email protected]
AGENDA
1.Welcome and introductory remarks.
2. Introductions.
AGENDA
3. Ongoing projects and initiatives: CCTCC: – Marketing Canada as a go-to-destination for clinical
trials at BIO 2016. – CCTAM – mCTA – Fair Market Value (FMV) Working Group (WG)
AGENDA
3. Ongoing projects and initiatives:
CTO: – Streamlined Research Ethics Review System BCCRIN: – Clinical Trial Participation Survey – Permission To Contact (PTC) demonstration project
with the BC SPOR Support Unit
AGENDA
4. Round-table updates 5. Other:
• New investigator training
6. Adjournment & Next Meeting.
ABOUT CCTCC • Promoting Canada as a leading destination for the conduct
of clinical trials (CT) • Underpinnings in the recommendations of the Action Plan to
Help Attract More Clinical Trials to Canada • Funded by Innovative Medicines Canada, CIHR,
HealthCareCAN. Housed at Health Charities Coalition of Canada
• Visit – www.cctcc.ca CCTCC www.cctam.ca |[email protected]
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.
PROJECTS
Key Projects:
• CCTAM - launched June, 2015, currently over 1000 assets • Model Clinical Trial Agreement (mCTA) – expected launch
Sept, 2016 • Fair Market Value WG – addressing clinical trial (CT)
budget issues • Investment case for conducing CTs in Canada • CCTCC CT round-table at BIO 2016
WELCOME
10
The purpose of this presentation is to provide a concise resource for Canadian clinical trials partners to communicate the landscape, advantages and continual advances being made to make Canada a desired destination for clinical trial investment. This presentation is designed to be delivered in person with much of the content in the speaking notes, however, it is also a credible source of information and could be posted or distributed electronically.
Clinical Trials: The Canadian Advantage
March 2016
The Canadian Landscape
12
Health and medical research is a priority for Canadians. A very strong majority (90%) say it makes an important contribution to health care while a strong majority (77%) say it makes an important contribution to the economy.
CanadaSpeaks 2015 poll, Research Canada
13
Canada boasts a high quality of life, stable business environment, educated workforce and diverse patient population.
15
We are in a global leadership position in areas that include basic and translational research:
•Cutting-edge genomics research in British Columbia •Exciting industry activity in virology in Alberta •World-class resources for R&D in virology in Saskatchewan •Groundbreaking infectious disease public health lab in Manitoba •Top-ranked research in cancer, stem cell and regenerative medicine in Ontario •Globally renowned centres for neuroscience and cardiovascular research in Quebec •Exceptional facilities for vaccinology in Atlantic Canada
17
There is a unique commitment between industry, government and the institutions to improve the operational environment for clinical trials in Canada. In 2013, the Canadian Clinical Trials Coordinating Centre (CCTCC) was launched to address challenges identified through the 2011 Canadian Clinical Trial Summit to make Canada a destination of choice for clinical trials.
The Canadian Advantage
19
Why Canada
Speed
Quality
Incentives ($)
SPEED 1) Fast Regulatory Approval
oRigorous 30-day Health Canada target to review clinical trial applications o In 2013 Health Canada achieved 99% target for study applicants received
2) Patient Enrollment oAverage time from trial set-up to First Patient First Visit is 3 months o 98% of subjects enrolled within the planned study period
3) Operational efficiency Improvements through the Clinical Trials Coordinating Centre (CCTCC)
oPan-Canadian Contract Template (mCTA 2016) oCanada Clinical Trails Asset Map (CCTAM) oProvincial leadership in REB efficiencies such as: (add examples provided
from CCTCC)
SPEED
SPEED Canadian Clinical Trials Asset Map (CCTAM)
o First pan-Canadian & pan-therapeutic database of Canadian clinical trial resources
oUpdated and comprehensive contact information oUser-friendly & customizable data searches o Free to data contributors & clinical trial sponsors
QUALITY
• • World class research institutes and academic hospitals
• Top 5 countries globally for research reputation in clinical medicine, biomedicine and overall science & technology
•The University of British Columbia in Vancouver
•The University of Toronto •McGill in Montreal
•98% patient recruitment success rate
•N2’s It Starts With Me program
•Among the 20 most ethnically diverse countries in the world
• Can accommodate trials in all therapeutic areas
Patient Diversity
Patient Recruitment
Reputation 3 of World’s
Top Universities
QUALITY
QUALITY
Clinical trials underway across all major treatment areas including cancer, CNS, metabolic and cardiovascular disease
QUALITY Universal Healthcare System
• Canada’s universal healthcare system provides quality and cost advantages for conducting clinical trials • On average, there are 2.1 doctors and 7.9 nurses per 1,000 people • Ensures a common and high standard of care for patients before, during
and after the clinical trial
• This results in superior data accuracy and quality from all trial sites
INCENTIVES
• Historically low CDN exchange rate
• Sustainable business environment
• Reasonable salary costs for highly-skilled personnel (Less expensive to place Global staff in Canada over the USA)
• Low R&D Tax Burden
1 KPMG Competitive Alternatives 2014 2 Total tax index is a measure of the total taxes paid by a company expressed as a % of the total taxes paid in the US.
INCENTIVES
• PwC and KPMG reported that Canada’s R&D tax treatment is one of the most favourable in the world2,3
• Canada’s SRED research tax credit can significantly reduce the cost of clinical trials in Canada
• SRED program can amount to a 15% tax credit for a company’s expenditures on eligible R&D1
• Individual provinces have additional tax credits for R&D ranging from 4.5% to 20%1
• Total tax credits from 15% to 32% on eligible R&D expenses1
1SRED April 2014 Factsheet; 2 KPMG. R&D incentives and services – adding value across the Americas. 2012 ed; 3 Presentation to R&D Tax Symposium, 23 May 2011. “Tax Policy – the role of R&D tax incentives” by Mark Parson, PwC Canada , Canada Revenue Agency website (accessed 23 Sept 2014)
Perceived Roadblocks for Investment • Geography – Canada is a large country.
• In reality, the bulk of the population is within 100 miles of the US border. • There are clusters of clinical trial sites in Canada.
• Contracts – The contracting process slows down start-up times. • The CCTCC will launch an updated version of the mCTA in 2016.
• A Fair Market Value working group has been formed to address budget negotiations.
• Fragmented Health Systems – Different rules in different provinces for multi-site trials make things complicated. • Provincial CT organizations are working together and sharing best
practices to reduce these challenges.
Opportunity
Industry, government and research institutions recognize that continual improvements to the business environment are required so that Canada maintains global advantages in Speed, Quality and Incentives.
Success Starts Here
Speed
Quality
Incentives ($)
Alternate Slides
Why Canada? Asset map
Why Canada? Efficiency
QUALITY
BRAINSTORM
The Canadian Advantage Brainstorming Session
• SPEED • COST • QUALITY
WHAT IS CCTAM? • One of CCTCC’s key outcomes • Web-based, “living”, easily searchable, interactive, comprehensive database of
Canadian clinical research capabilities – researchers, clinical research sites, hospitals, institutions, research ethics boards, CROs, SMOs , etc.
• Better enable sponsors of clinical trials to identify clinical research sites and investigators
• Position Canada as an attractive destination for the conduct of clinical trials in the global marketplace
CCTAM www.cctam.ca |[email protected]
CCTAM – UNIQUE
• First pan-Canadian & pan-therapeutic database • Regularly updated • Free to data contributors • Easy to use • Able to grow & develop
UNIQUENESS www.cctam.ca |[email protected]
CCTAM www.cctam.ca |[email protected]
CCTAM www.cctam.ca |[email protected]
CONTACT US. WE ARE ACCESSIBLE
WEB: www.cctam.ca EMAIL: [email protected] Phone: 1-844-452-5818 Twitter: @CCTAMap
CONTACT www.cctam.ca |[email protected]
THANK YOU! Thank You
CLINICAL TRIALS ONTARIO• Independent non-profit, established in June 2012 and funded by the Government
of Ontario
• Established to address the decline in clinical trials in Ontario and leverage Ontario’s clinical research capabilities to attract more investment
CTO REB QUALIFICATION PROGRAM
Provides REBs planning to participate in the CTO Streamlined Research Ethics Review System with an external review of their governance, membership, operations and review procedures.
Based on the Toronto Academic Health Sciences Network (TAHSN) qualification process.
REBs are reviewed against a transparent standard, the CTO REB Qualification Checklist, that is informed by the applicable regulations, policies and guidelines. REB Qualification Manual available at www.ctontario.ca.
CTO REB Qualification checklist aligned with the N2/CAREB REB SOPS.
Each full visit is conducted by a Qualification Team composed of: Auditor with specific training relating to review of REBs CTO Program Coordinator Two experienced members from the research ethics community (e.g., REB Chair/Vice-Chair
and REB Director/ Manager/ Coordinator) selected from the CTO College of Reviewers.
CTO STREAMLINED RESEARCH ETHICS REVIEW SYSTEM
Supports a single REB in providing research ethics review and oversight to multiple research sites; relies on a “REB of Record Model”
REB oversight responsibilities delegated by participating institutions to the REB of Record
Can be used for any multi-site clinical research, i.e. industry sponsored or investigator initiated
Currently can accept multi-site clinical trials; in future multi-site health research will be accepted as well
CTO STREAM
CTO Stream is a standalone web-based electronic platform:
Enables research ethics review, document management, and communication between multiple institutions and REB of Record
Common application forms – all REBs use it; template consent form
Designed and built by Infonetica (UK), CTO and the CT community
Supports any file type for uploads (i.e., word documents, excel documents, pdfs and text files)
Built using smart questions and smart forms; applications can be drafted by sponsors
Electronic signatures for all applications; User friendly
REB OF RECORD MODELInitial Application Process
REB application submitted by any registered investigator/site, i.e. “Provincial Applicant”
CTO assigns REB of Record (any Qualified REB in Ontario) and advances application
REB of Record reviews application and resolves any issues with applicant
Once issues are resolved REB of Record approves study
Recruiting Institution signs REB of Record Agreement, delegating ethics review and
oversight to REB of Record; Local PI adopts approved consent form and submits site
application focused on site specific information
Site application advances to REB of Record
REB of Record Host Institution signs REB of Record Agreement and REB reviews
application (usually expedited) and resolves any issues with site applicant
Step 1Applying for a New Multi-Centre
Clinical Trial
Step 2 Adding New Investigators /
Research Sites
Sites wishing to participate are notified and given access to REB materials in CTO
system
REB of Record issues approval for site to participate
Continuing Oversight and Approval
Documentation submitted by “Provincial Applicant”
REB of Record reviews submission and resolves issues with provincial applicant
Once issues are resolved, approval or acknowledgement is issued by REB of Record
and sent simultaneously to all approved participating sites
REB of Record reviews submission and resolves issues with research site
Approval or acknowledgement issued by REB of Record
New overall (study-level) event, e.g. amendment, Data Safety Monitoring
Board report, safety update
New site level event, e.g. continuing (annual) review, local Serious Adverse
Event, protocol deviation
Documentation submitted by research site
REB OF RECORD MODEL
CONTACT INFORMATION
Website: www.ctontario.ca
E-mail: [email protected]@[email protected]
@clinicaltrialON
linkedin.com/company/clinical-trials-ontario
Clinical Trials Ontario661 University Avenue, Suite 460MaRS Centre, West TowerToronto, Ontario Canada M5G 1M1 Tel / 416 673-6670
ENGAGE. LISTEN. ACT.
Learning From the Participant Experience: The Canadian Clinical Research Participation Survey
Alison Orth, BBA, CCRC - Project Manager, BCCRIN
45
The Recruitment Challenge
SITES
SPONSORS/CROS
REGULATIONS/PRIVACY
MEDIA
PUBLIC
Connect. Communicate. Learn.
SITES
PUBLIC
Public Engagement
The Canadian Clinical Research Participation Survey
www.bccrin.ca/survey
MEETING THE CHALLENGE
48
Survey Rationale
• Directly engage Canadians in discussion and feedback on clinical trials Engage
• Obtain current national and provincial data from those who have been offered to participate in a clinical trial Listen
• Develop evidence-based best practice recruitment & retention strategies
• Promote awareness of the essential contribution made by clinical trial participants
Act
49
THE GOAL: Improve recruitment success
Engage the public, researchers and industry
Translate knowledge
Evaluate success
Continuous Quality Improvement
50
Phase I – British Columbia 2012-2014
Collaboration
•Task force designed and peer reviewed
•Harmonized ethics review
•Paper and Web-based Survey
•REDcap hosted by Child and Family Research Institute
Outreach
•Connected with 74 sites to distribute survey to patients
•Visits, calls and regular emails with sites
•Disease advocacy/info groups engaged
Recruitment
•Advertising/Press Release
•Web/Social Media •Patient groups • Inform patients
when visiting a hospital, clinic or research site
51
What We Collected
Demographics Disease or medical condition
Type of treatment studied
Reasons for Declining
Reasons for Agreeing to Participate
The Screen Failure Experience
The Clinical Trial Experience
The Study Cancellation Experience
Impact of Physician Decision
to Withdraw
Reasons for Self-Withdrawal
•detailed and comprehensive •total of 62 questions •adult and pediatric (parent) cohorts
52
SURVEY RESPONDENTS
Extent of clinical trial involvement 596 were considered valid (answered at least both age and gender)
Completed 77%
Declined 13%
Discontinued Prematurely
10% N=596
53
SURVEY RESPONDENTS
Therapeutic area under study
0%2%4%6%8%
10%12%14%16%
54
DEMOGRAPHICS
Age and Gender
PARTICIPANTS Participant
Decliner
N 497 69 Gender : % Female 62% 75% % Male 38% 25% Age (Mean, range) 51 (14 to 88) 46 (18 to 81)
PARENTS ENROLLING CHILD Parent
Consenter Parent
Decliner N 24 06 Child’s Gender % Female
38% 17%
Child's Gender % Male 62% 83% Child's age (Mean, range) 5.7 (0 to 17) 4.7 (0 to 12)
55
DEMOGRAPHICS
Highest level of education completed
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
High Schoolnot completed
High Schooldiploma
SomeUniversity or
College
College/University
degree
Graduatedegree
Post-graduatedegree
1) Participant
2) Decliner
56
DEMOGRAPHICS
Household income level
0%
5%
10%
15%
20%
25% 1) Participant
2) Decliner
57
DEMOGRAPHICS
Ethnic/racial background
1) Participant 2) Decliner
Vancouver/Lower Mainland/South Coast 313 (63%) 51 (76%) Other parts of BC 184 (37%) 16 (24%)
497 67
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
% Respondents
% Census 2006
58
ADULT DECLINERS N=60
Reasons for declining
Did not have time due to work/commitments 50%
Trial too burdensome or demanding 37%
Did not feel health would benefit 34%
Wanted to be paid more for time and expenses 24%
Would if trial was outside of working hours 23%
Top 5 of 25 “Agree and Strongly Agree” Responses
59
ADULT DECLINERS N=60
Reasons with low impact on decision
• Required my GP be made aware and I did not want to agree to this
• Questions about study were not answered fully by the research staff
• Had concerns regarding the privacy of my personal information
• Did not understand English well
• Going on vacation/traveling
Low “Agree” and High “Disagree” responses
60
ADULT CONSENTERS N=497
Reasons for participating
Consent Form clear and easily understood 94%
Benefit others even if I didn’t benefit directly 87%
No commitments conflicting with study visits 69%
Doctor wouldn’t ask me if the risk was too great 64%
Thought participating would improve my health 63%
Top 5 of 12 “Agree and Strongly Agree” Responses
61
REASONS FOR PARTICIPATING
Conflicting commitments decrease by age
61% 61%
73% 81%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
14-39 40-51 52-62 >62
“I had no other commitments that made attending visits difficult”
Age Group in Years P-value = 0.00
62
REASONS FOR PARTICIPATING
Education level and expectation of health services
68%
47% 45% 38% 39% 38%
0%
10%
20%
30%
40%
50%
60%
70%
80%
No HighSchool
High School SomeUniv/Coll
Univ/Coll Graduate Post-graduate
“I felt I would have better access to health care services”
p-value = 0.01
63
REASONS FOR PARTICIPATING
Education level and expectation of health improvement
80% 75%
67%
57% 61%
54%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
No High School High School Some Univ/Coll Univ/Coll Graduate Post-graduate
“I felt participating would provide an improvement to my health”
p-value = 0.02
64
REASONS FOR PARTICIPATING
Education level and Consent Form comprehension
p-value = 0.02
84%
96%
91%
95%
91%
98%
75%
80%
85%
90%
95%
100%
No High School High School Some Univ/Coll Univ/Coll Graduate Post-graduate
“The informed consent form was clear and I understood it well”
65
THE CLINICAL TRIAL EXPERIENCE
Non-inclusive summary...
I felt well-cared for by the research staff 87%
The study team was available to answer my questions 86%
Participation had a positive impact on my health 46%
AGREED with:
DISAGREED with:
Research staff not as professional as I expected 85%
I experienced unpleasant side effects 66%
Study requirements more than I originally anticipated 61%
Note: Total of 15 questions
66
Impact of Experience on Future Trial Participation
89%
73% 67%
100%
81% 92%
83%
0%
20%
40%
60%
80%
100%
120%
Participated Declined ScreenFailure
WithdrewSelf
Withdrawn StudyCancelled
Parentconsenters
“Given my experience I would consider participating in another clinical trial”
67
Common Challenge - Collaborative Response
“The Canadian Clinical Trial Participation Survey”
Enrollment: 703/2000 March 2016 BC 674 Quebec 3 Ontario 20 Other 6
• Ability to look for regional differences in responses
• Increase sample size for our subsets (pediatric, screen failures, early discontinuations, study cancellation, ethnic/cultural diversity)
• Correlative analysis across therapeutic areas
• Potential for Quantitative analysis
68
• Dec 2015 Announcement via CCTCC, N2, BCCRIN and partners
• Feb 25, 2016 Revised materials approved by Harmonized REB in BC
• Mar 2016 Communications with sites, initiate institutional and REB approval process if required. Communications with disease advocacy groups and communications across institutions and networks
• Apr 2016 Work with CTO streamlined REB team, French version, additional communications material created, N2&BMC distribution
• May 2016 Independent sites outreach
• Jun 2016 Continued outreach and support of participating sites, networks
• Jul 2016 Evaluation of progress and report on enrollment
• Sep 2016 Planned completion of enrollment 2000 surveys
• Oct-Dec 16 Formalize knowledge translation plan
National Survey Timelines Update