WELCOME.. Foundations “Clinical trials save lives and improve quality of life for Canadians. Clinical trials are also an important economic engine for.

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

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

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 www.cctcc.ca; December 2014

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

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 CertificationCommon 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 2015.• 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 www.cctam.ca

– 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

CCTAMwww.cctam.ca |[email protected]

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. 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.