WELCOME.

Foundations “Clinical trials save lives and improve quality of life for Canadians. Clinical trials are also an important economic engine for Canada. With the Canadian Clinical Trials Coordinating Centre, we will seek to attract more clinical trials to Canada, for the benefit of our economy, and most importantly to the benefit of Canadian patients”. Rona Ambrose, Minister of Health, 2014

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 – Jeff Latimer, Erica Dobson ◦Rx&D – Alison Sargent, Elena Aminkova ◦HealthCareCAN – Tina Saryeddine Staff ◦Director, Implementation – Belinda Vandersluis ◦Coordinator, Communications and Strategy – Leyla DiCori Executive Committee Advisory Group Director Implementation Staff, Consultants Working Groups Secretariat

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; December 2014 Web and news tools at December 2014www.cctcc.ca REC #1 – National Headquarters

REC’Ms Academia / Institutions Presentations CAREB, MICYRN, BCCRIN, Q-CROC McMaster, Thunder Bay Regional Research Institute, Royal Victoria Hospital, CHEO & Ottawa Hospital Research Institute SPOR Support Unit Council Network of Networks REC #1 – National Headquarters

REC’Ms Update to Action Plan Report since 2013; March 2015 Update 2010 Industry Benchmarking survey; Jan-June 2015 First year evaluation of CCTCC scheduled; February 2015 –Investment in Canada $, international ranking –Short term milestones set and goals met –Future year(s) strategy and plans REC #2 – Measure Results

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. –CCTCC Working group ‘what would accreditation look like’; Jan-July 2015 REC’Ms

Patient registries database. –Working initially to define ‘patient registry’, then develop a database of current patient registries; developing plans for 2015 Patient information, educational sessions for health charities and patient advocates; spring 2015 REC #5 – Patient Registries and Recruitment

REC #6 – Common Tools and Site Certification Common Tools: Meetings ongoing with N2: SOPs, GCP Training, Common Forms and Tools Site Certification: Quantify ‘Clinical Trial Sites’ in Canada; working with Health Canada CTSI databases; March 2015 Future working group: What would ‘site certification’ look like? REC’Ms

REC #7 – mCTA Model CT Agreement Pilot phase completed, provincial reviews completed. mCTA available. Current: Industry endorsement, review with ~10 companies; Jan-Feb Next steps: CRO engagement in 2015 (after industry review) Future steps: development of other agreements - data sharing, confidentiality and non disclosure, etc. REC’Ms

REC #9 – Signaling our Interest Globally CCTAM: Canadian Clinical Trial Asset Map –HealthCareCAN hosted 2 webinars; testers from institutions –Communications packages (eng/fr) available –Rollout goal date ~March 2015 New “Business Case” for clinical trials in Canada with DFAT Investment Services, used to engage global investors. Nearly completed. REC’Ms

CCTAM

Summary The CCTCC aims to regain Canada’s competitive advantage as a country in which to conduct clinical trials. ◦ We coordinate activities, communications, advisory and working groups ◦ We connect partners, find and support synergies ◦ We provide a portal to collate, disseminate and share information ◦ We showcase Canada’s ability to conduct high quality clinical trials and be competitive in the global marketplace

CONTACT US. WE ARE ACCESSIBLE or Albert Street, Ottawa Ontario Belinda Vandersluis, Director Implementation Leyla DiCori, Communications and Strategy Coordinator General info: CONTACT

THANK YOU.