CLINICAL RESEARCH IN CANADA
A Roadmap for Enhancing Canada's Global Competitiveness
______________________________________________________________

Introduction: Opening Remarks from the Conference Chair
Pierre Gervais, B. Pharm., M.Sc., President, Research Director, O&T Research
Sherbrooke, Research Director, O&T Research, Outaouais and Chicoutimi


1. Keynote: Clinical Trials Global Landscape
Kenneth A. Getz, MBA, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts Medical School
Owner/Founder, CenterWatch Founder and Board Chair, The Center for Information and Study on Clinical Research Participation (CISCRP)

• Overview of the current operating environment and its impact on sponsors, CROs and investigative sites
• Solutions implemented to transform R&D, accelerate drug development and reduce costs
• New approaches and opportunities to improve development performance and efficiency
• New initiatives to raise public awareness and rebuild public trust in clinical research
  
  
  

2. Keynote Panel: Sponsors’ Perspective on Canadian Clinical Trials: Challenges and Potential Solutions
Moderator:
Kenneth A. Getz, MBA, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts Medical School
Panelists:
Dr. Shurjeel Choudhri, MD FRCPC, Senior Vice President & Head, Medical and Scientific Affairs, Bayer Inc.
Dr. Stanislav Glezer, MD, MBA, VP, Medical Affairs, sanofi-aventis Canada Inc.
Jean-Jacques Rousseau, MBA, (A) Manager, Life Science Programs, Ontario Ministry of Research & Innovation
Manon St-Pierre, Director of Research, Innovation and Knowledge Transfer, Quebec Ministry of Health and Social Services

• Why are we at a crisis point?
• What are the main causes?
• What are the consequences?
• What are some potential solutions?
• Having launched the Life Sciences Commercialization Strategy, the Ontario Ministry of Research & Innovation will discuss what steps it is taking to streamline ethics review and contracting to help maximize its share of global clinical trials activity
• The Ministry of health and social services initiative regarding the negotiation of research contracts between the academic hospitals and pharmaceutical and/or device companies:
  • Background: The origin of the Quebec initiative
  • Solutions: Why reinvent the wheel?
  • Particularities to consider in Quebec
  • Other initiatives in Quebec and Canada: the need for dialogue
    
    

3. Panel: Clinical Trials SWOT Analysis: Diagnosis Before Prognosis
Ayman Chit, HBSc, M.Biotech, Scientific Advisor & Health Outcomes Scientist, Vaccines, GlaxoSmithKline (Canada)
Ron Fehst, IRB Services, Former Senior Regional Research Manager, Eli Lilly Canada Inc.
Ronald Heslegrave, PhD, Member, Expert Panel on Research Integrity, Senior Scientist, Research Ethics, University Health Network, University of Toronto
Dominique Johnson, PhD, Director, The Montreal Heart Institute

4. Principal Investigator’s Perspective:Clinical Trials & the Personalized Medicine Landscape
Dr. Philippe Bedard, MD FRCP(C), Assistant Professor, Department of Medicine, University of Toronto
Principal Investigator and Medical Oncologist, Princess Margaret Hospital

• The growing use of biomarkers in cancer clinical trials
• Methodology and the use of prognostic multi-gene signatures in early-stage breast cancer
• Genomic selection of patients for early phase clinical trials
• How Canadian clinical trials are impacted by personalized medicine
  
  
  

5. Research Integrity in Canada: Enhancing Transparency and Accountability
Ronald Heslegrave, PhD, Member, Expert Panel on Research Integrity, Senior Scientist, Research Ethics, University Health Network, University of Toronto

At the request of Industry Canada, the Council of Canadian Academies conducted an assessment examining the key research integrity principles, procedural mechanisms, and appropriate practices for their application across research disciplines and institutions in Canada.

This presentation will focus on the results of the assessment and share insights into how clinical research will be impacted going forward.

Key discussion points include:

• The role of the newly proposed Canadian Council for Research Integrity (CCRI)
• The key research integrity principles, procedural mechanisms and practices appropriate in the Canadian context that could be applied across research disciplines at institutions receiving funds from the federal granting councils
• The four key gaps identified in Canada’s Policy Framework and how they will be addressed through the CCRI
• How Canada is different and how we align with emerging global standards
• The state of research integrity and misconduct policies in Canada and what actions would be considered to constitute research misconduct in a Canadian context
• What are the roles and responsibilities of all those involved?
• How could a common research integrity definition foster a research culture of high ethical standards and instill public confidence?
  
  
  

6. National Initiatives and Innovation in REB Review in Canada
Sharon Freitag, Director, Research Ethics Office, St. Michael’s Hospital, President, Canadian Association of Research Ethics Boards (CAREB)

• Tips for ethical approval for clinical research
• Challenges with adverse event reporting
• How multi-centered trials in Canada are impacted by ethics review
  
  
  

7. Tracking Phase 1 Trial Participants
Khaled El Emam, PhD, Associate Professor, Canada Research Chair in Electronic Health Information, Faculty of Medicine and the School of Information Technology and Engineering, CHEO Research Institute and the University of Ottawa

• An overview of ‘professional’ phase 1 trial participants and the risks they introduce
• Privacy challenges and potential solutions
• The role of technology to drive this success
  
  
  

8. Field Perspective: Implementing an Adaptive Design:  Increasing Efficiencies and Improving ROI
Jack Corman, President, IRB Services
Pierre Gervais, B. Pharm., M.Sc., President, Research Director, O&T Research, Sherbrooke, Research Director, O&T Research, Outaouais and Chicoutimi

The goal of Adaptive Design is to speed drug development by increasing efficiencies and identifying best candidates with the right dose earlier, or conversely knocking the poor candidates out quickly with the goal to doing fewer long and costly studies in Phases II & III.

This presentation will focus on key strategies for implementing a successful Adaptive Design including:

• Strategies to improve the success rate of convention clinical trials with Adaptive Design
• Maintaining access to patients with complex design studies
• How to streamline organization and structures
  • study schedule, data entry, queries, volume of supplies
• Steps to overcoming adaptive design challenges for ethics review boards
• Ethical review during a trial – is this necessary for each new development?
• Opportunities for keeping lines of communication open
  
  
  

Agnes V. Klein, MD, Director, Center for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada

Division 5, the new regulations for Clinical Trials (CTs) have been implemented for over 5 years now. The implementation was fortuitous because it arrived at a time when the cost of studies had increased and when quality and timeliness of the evaluation, as well as the conduct of these studies, became critical.
Five years later, HC has conducted several interactive consultation workshops in order to evaluate the benefits of the new regulations.

This presentation will look at:

• Various perspectives on the new regulations
• The effect they had on the conduct of trials and on the review of proposals
• Provide insight into new endeavours that would enrich the CT-scape in Canada
• Current status and future directions in CTs
• Relative competitiveness of Canada in the CT field
• Concerns related to the conduct of CTs
• The benefits of the Canadian health care system in terms of CTs
• The benefits of CTs to the health care system
• A discussion of current “hot issues and areas”

10. Top 10 Do’s & Don’ts for Clinical Research Sites

Raffi Chamlian, BPharm, Clinical Research Manager, International Centre for Therapeutic Research-Canada, Servier Canada Inc.

To assure Canada’s position in the global arena, we must select high performance sites to maximize patient recruitment performance while preserving quality.
This presentation will cover:

• How are institutions, sites and investigators identified? How do they get on the short list? How do they get into the final group?
• What metrics are used to make this decision?
• Proactive engagement strategies for optimal site selection
• Opportunities for creating greater collaboration between industry sponsors and site investigators
• How to keep the research team motivated and committed to their recruitment target

11. Social Media and Its Impact on Clinical Trials
Karine Côté, RN, Bsc. Adm., Associate Director, Patient Recruitment Specialist, O&T Research Sherbrooke
Deirdre Cozier, Manager, Regulatory Operations, Policy and Clinical Trials, sanofi-aventis Canada Inc.

• Patient recruitment, retention, advocacy and knowledge
• Transparency, integrity, confidentiality, privacy and oversight
• Are there social media guidelines in place?
• How do you triage adverse events if reported online?
• How will you manage negative feedback about the study?
• Global trends; successes and failures