The Model Clinical Trial Agreement (mCTA): Improving Efficiency, Speed, and Costs of CT Negotiations

1. The Model Clinical Trial Agreement (mCTA):Improving the Efficiency, Speed and Costs of CT Negotiations mCTA

2. The PROBLEM • The time required to execute clinical trial agreements (CTAs) globally has doubled since 20101 • For CTAs in North America, traditionally a top performer, times have increased from 1.3 months in 2010-11 to 2.4 months in 2014-151 • Delays in initiating trials2 : • Slow down the access to new treatment options for patients • Increase the costs and time required for sponsors to bring drugs to market • Decrease recruitment windows resulting in potential loss of opportunities for sites to recruit patients for trials • A significant reason for these costs and delays is the time and resources required to draft a unique agreement for each trial in Canada • Yet, about 75% of the content in clinical trial agreements is virtually identical3 The Problem

3. The solution • Create a single, standardized model CTA (mCTA) that can be used for all clinical trials in Canada, for a more effective use of resource • Make the mCTA accessible online and easy to use, so that it is used widely throughout Canada by all stakeholders • Integrate an mCTA e-tool that facilitates ongoing improvement of the contract by encouraging feedback by users and tracks metrics such as: • Speed of contract negotiation • Rate of use of the mCTA • Nature and frequency of amendments • Target date for early adopters roll-out is mid 2017! For more information visit our website here THE SOLUTION

4. Why the mCTAwill succeed 1. Extensive Stakeholder Collaboration • Developed in broad consultation with sites/institutions and sponsors and reviewed by relevant stakeholders across Canada • Partnership with CLEAR Initiative1 (TransCelerate-supported project) • The CLEAR clauses have received feedback from Canada to reflect the Canadian context2 • The CLEAR clauses which reflects agreement on the five most controversial areas for CTAs3, were incorporated in the mCTA • The resulting mCTA (Version 8) was reviewed by an independent legal counsel for the purposes of ensuring consistency of terminology use and definitions, and clarifying ambiguous wording4 3.Robust Communication and Change Management Strategy • Implementation of communications and change management strategy • Independent legal review was conducted to • Use of the mCTA tracked with an e-tool, so it can be continually improved, reviewed annually and regularly updated due to received feedback and legislative changes 4

5. Who is involved? • CCTCC and its Funders: • Works to improve the operational environment for clinical trials in Canada and promote the country as a destination of choice for clinical trials • Canadian Institutes for Health Research (CIHR) – Canada's federal funding agency for health research • Innovative Medicines Canada - the national voice for research-based pharmaceutical companies • HealthCareCAN - representing healthcare organizations and hospitals across Canada • Representatives Providing Input and Feedback • Some of the largest pharmaceutical companies1 conducting CTs in Canada • Research institutes, universities, health authorities, health networks, hospitals, healthcare agencies, and provincial clinical trial organizations from across Canada2 Who is involved?

6. WHAT THE mCTA MEANS FOR INDUSTRY • Accelerates site initiations, leading to more efficient study start-up process and increased time for recruitment • Contributes to the reduction of the overall drug development process • Uses CT resources more effectively • Significantly streamlines process, especially for multi-site trials • Enhances Canada’s global competitiveness in attracting clinical trials • Levels the playing field for academic and public sector organizations, which often do not have the same legal resources as sponsors

7. WHAT THE mCTA MEANS FOR INSTITUTIONS/SITES • More global clinical trial opportunities • More treatment options for our patients • A more efficient approval process, including quicker turnaround times and decreased contracting costs • Contracts that have a better balance of risk and responsibilities for those involved • Support for clinician investigators, including: • More clinical trials to offer their patients • Greater likelihood of being a first or top recruiter in Canada

8. WHATTHE mCTA MEANS FOR PATIENTS • Gets new treatments in development to patients faster • Brings life-saving products to market earlier, improving and potentially saving patients’ lives As a melanoma patient waiting to get on a clinical trial said, “To you it’s a document. To me it’s my life.” Remember, the patient might be you, a member of your family or one of your closest friends. Any improvements we can make in clinical development help us all.

9. CONTACT US WEB: www.cctcc.ca EMAIL: mCTA@cctcc.ca/ info@cctcc.ca Phone: 613-233-5678

10. ADDITIONAL SLIDES MORE DETAILS

11. HOW THE mCTA WAS DEVELOPED • Pre-2011: - Council of Academic Hospitals of Ontario , representing sites/institutions, generates best practice principles for contract negotiations. • 2011/2012 - These sites/institutions work with Rx&D (now Innovative Medicines Canada) to release first version of mCTA. • 2013/2014 - An mCTA pilot takes place in the field and reveals a number of challenges, including issues around provincial differences. There is limited uptake of the mCTA at this time. • 2015 - CCTCC moves to revive the mCTA project by creating a Team Canada* to lead the process and review CLEAR clauses. • 2016: CCTCC surveys 41 sites/institutions and holds open houses to educate sponsors, get further feedback and encourage engagement. • *CCTCC’S Team Canada - includes representatives from sites, hospitals/institutions, provincial and pan-Canadian clinical trial organizations, sponsors, and CCTCC funders. MORE SLIDES

12. FEEDBACK PROVIDED BY: ZZZ Institutions/ Sites Sponsors Provincial CT Organizations