CLINICAL TRIALS IN CANADA

Attracting and retaining patients is critical to the success of clinical trials and has become even more challenging in today’s global market.
This 9th Edition of Insight Information’s popular CLINICAL TRIALS IN CANADA Series will provide you with practical solutions to help you optimize patient participation in your trial. Issues to be addressed include:

• An international perspective on meeting participant protection challenge
• Overcoming barriers to patient recruitment and physician participation
• The potential of web-enabled technologies, including social media, to increase collaboration between investigative sites and patients
• Pharmacokinetics and first-in-man studies: safety in healthy subjects
• Patient retention in long-term trial from the patient, investigator and sponsor perspective
• Patient recruitment and ethics: what every physician should know
• How clinical trials impact a physician’s clinical practice and their patients
• The role of research ethics boards on patient safety – do they make a difference?
• Managing patient privacy: legal and technical challenges
• How to succeed with a recruitment campaign and overcome negative public perception
• What you need to know about informed consent

PROGRAM CO-CHAIRS

Dr. Catriona McMahon, BSc., MBChB, FRCA (UK), MFPM (UK) 
Vice President, Medical Affairs
AstraZeneca Canada Inc.

Margaret H. Kerr, B.A., LL.B., M.A., Ph.D. 
Barrister & Solicitor

Keynote Address

A New National Strategy on Patient-Oriented Research

Peter Liu, M.D.
Scientific Director
Institute of Circulatory and Respiratory Health, CIHR
Professor, Medicine and Physiology
Toronto General Hospital
University of Toronto

MARKETING PARTNER

Life Sciences Industry Sponsors including Pharma, Biotechnology and Medical Devices, CROs, Institutions, Site Management Organizations (SMOs), Patient Advocacy Groups, Patient Recruiting Agencies including:

• Chief Medical Officers and Medical Directors
• Heads of Medical Affairs and Clinical Research
• Heads of Clinical Operations
• Heads of Clinical Research
• Heads of Scientific Affairs/Government Relations
• Research Ethics Board Members
• Clinical Investigators
• Study Coordinators and Study Nurses
• Project Leaders and Research Associates
• Site Managers, Monitors and Auditors

• Heads of Quality Control/Assurance/Compliance/Ethics
• Health Canada, Senior Advisors, Researchers and Policy Developers
• Health, Pharma, Medical Device and Biotech Lawyers
• Health, Pharma, Medical Device and Biotech Trade Association Representatives
• Clinical Trial Consultants and Service Providers
• Insurers/Defence Providers
• Agencies that fund research, including governments, research charities, and medical research councils

AstraZeneca Canada Inc.
Biovail Contract Research
Canadian Association of Research Ethics Boards
Canadian Institutes of Health Research
Canadian Medical Association
CHEO Research Institute
Eli Lilly Canada Inc.
Genome Canada
Health Canada

Interagency Secretariat on Research Ethics, Ottawa, Canada
LxB Communications
Margaret H. Kerr, Barrister & Solicitor
Q&T Research
Toronto General Hospital
University of British Columbia
University of Ottawa
University of Toronto
Women’s College Research Institute

Dear Colleague,
This 9th Edition of our CLINICAL TRIALS IN CANADA series is focused on providing strategies and solutions that will help you optimize patient participation in a competitive global environment.
Recruiting and retaining patients is critical for drug development. Achieving useful results in a study rests on doing both well. Failure to meet recruitment targets can potentially sabotage years of preliminary research
Presentations at this Insight Information conference will provide perspectives from patients, ethics boards, principal investigators, CROs, institutions and bio/pharmaceutical companies, and will touch on everything from ethics and legal responsibilities to effective communication with targeted patients and the safety of human subjects both nationally and globally.
Please join us and take this opportunity to learn how you can gain efficiencies and increase patient participation in your studies, through a variety of presentations, case studies, and panels with both Canadian and international perspectives.
We look forward to seeing you in Montreal April 29-30.

Dr. Catriona McMahon, BSc., MBChB, FRCA (UK), MFPM (UK) 
Vice President, Medical Affairs
AstraZeneca Canada Inc.

Margaret H. Kerr, B.A., LL.B., M.A., Ph.D. 
Barrister & Solicitor

Thursday, April 29, 2010

8:15

Registration and Coffee

9:00

Welcome and Opening Remarks from Co-Chair

Dr. Catriona McMahon, BSc., MBChB, FRCA (UK), MFPM (UK) 
Vice President, Medical Affairs
AstraZeneca Canada Inc.

9:10

Participant Protection Challenges: An International Perspective

Miriam Shuchman, MD 
Associate Professor, University of Toronto
Psychiatry
Research Ethics Board Chair
Women’s College Research Institute
Author, The Drug Trial

• How regulators have responded to these challenges globally
• Where have researchers run into trouble?
• What do they need to do differently going forward?
• How can researchers achieve innovation without compromising participant protection

10:00

Optimizing a Recruitment Campaign

Paul Bergeron 
Executive Vice President & General Manager
LxB Communications

• Why do patients take part in clinical trials?
• What are the biggest roadblocks to participation?
• How to select the right media mix

10:45

Networking Coffee Break

11:00

Patient Recruitment Strategies: How to Succeed With a Recruitment Campaign and Overcome Negative Public Perception

Karine Côté, BBA, RN
Associate Director, Operations and Recruitment
Q&T Research – Sherbrooke

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director, Q&T Research – Sherbrooke
Research Director, Q&T Research – Outaouais
Research Director, Q&T Research – Chicoutimi

Q & T Research is made of independent clinical research sites working exclusively in Phase II-III clinical research. Q&T was involved in more than 100 trials in the last 10 years and has recently implemented its own recruitment centre with locally targeted recruitment strategies. This presentation will discuss root cause analysis for low recruitment, strategies to address these challenges, implementation of solutions and grid results.

• Recruitment reality for a research center
• Perception of general public in Sherbrooke with focus groups
• Segmentation and positioning strategies
• Patient recruitment strategies
• Some results of recruitment campaigns

11:45

Pharmacokinetic and First-in-Man Studies: Safety in Healthy Volunteers

Pierre Geoffroy, MD, CM, MSc, F.C.F.P. 
Medical Director and Principal Investigator
Biovail Contract Research

Bioavailability/bioequivalence studies are designed to compare the pharmacokinetic profile of two or more compounds or compound formulations. These may be an essential part of an approval dossier for a generic drug, but rarely do they provide any therapeutic benefit for study participants. First-in-man studies are designed to test the safety of a new molecular entity for, as the name implies, the first time in man. These studies may be conducted in volunteers with the disease of concern, but more often will be conducted in healthy volunteers. At best, drug testing in healthy volunteers presents a neutral benefit/risk ratio.
For this reason, and while volunteer safety should be a primary concern in all clinical studies, special emphasis must be placed on protecting the phase I study volunteer from harm. From study design to post-study follow-up, volunteer-centered safety checks best ensure the well-being of our study participants.
In this session, the attendee will learn about volunteer-centered study safety through:

• Discussion of measures to best safeguard the health of study volunteers via careful screening of subjects, on-study monitoring, and post-study follow-up
• Examination of safety endpoints in protocol design
• Review of adverse event evaluation

12:30

Networking Luncheon

2:00

Managing Patient Privacy in Clinical Trials

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

Patricia Kosseim 
Chief GE³LS Officer
Genome Canada

Through a series of case studies, presenters will describe the technical and legal challenges and provide guidance on privacy issues that arise in clinical trials, especially in the context of using electronic data capture systems:

• The patient and physician privacy interests in prescription records
• Privacy considerations with using electronic data capture tools
• The collection of personal information for large pharmacogenomic trials, including consent, governance and data sharing issues
• Data mining EMRs and EHRs to identify subjects for recruitment

3:15

So You Think You Know What An Informed Consent Is….

Margaret H. Kerr, B.A., LL.B., M.A., Ph.D. 
Barrister & Solicitor

• What is the legal purpose of informed consent – whom does informed consent protect?
• What is an informed consent document required to contain for clinical research?
• Does an informed consent document confer rights, and if so how can they be enforced?
• What is the relationship between an informed consent document and a study subject injury clause in a clinical trial agreement?
• How voluntary is voluntary consent in the clinical research setting?

4:00

Conference Adjourns for the Day

Friday, April 30, 2010

8:30

Coffee

9:00

Opening Remarks from the Co-Chair

Margaret H. Kerr, B.A., LL.B., M.A., Ph.D. 
Barrister & Solicitor

9:10

A New National Strategy on Patient-Oriented Research

Peter Liu, M.D. 
Scientific Director
Institute of Circulatory and Respiratory Health
Canadian Institutes of Health Research
Professor, Medicine and Physiology
Toronto General Hospital
University of Toronto

10:00

Patient Recruitment and Ethics: What Every Physician Should Know

Dr. Jeff Blackmer
Executive Director, Office of Ethics
Canadian Medical Association

Many physicians are increasingly concerned about the pressures to commercialize research, which raises potential conflicts of interest, and for some, ethical quandaries about receiving monies to boost patient enrolments in clinical trials. Still others raise concerns about patient safety and welfare. Some specific challenges to be discussed include:

• Is participation ethical?
• Is the sponsor offering too much money?
• Should the physician agree to sign a nondisclosure form?
• Patients’ expectations, trial transparency, disclosure of results, scientific validity, trial merits, patient risks, and, of course, financial opportunities contained therein

10:45

Networking Coffee Break

11:00

Clinical Trials and the Impact on a Physician’s Clinical Practice and Their Patients

Moderator
Dr. Jeff Blackmer 
Executive Director, Office of Ethics
Canadian Medical Association

Pierre Geoffroy, MD, CM, MSc, F.C.F.P.
Medical Director – Principal Investigator
Biovail Contract Research

Other panelists to be announced 

• What does the practicing physician think of clinical trials?
• Has it changed their practice?
• Barriers to patient recruitment and physician participation
• The future of evidence-based care

12:15

Networking Luncheon

1:30

Patient Safety and the Role of Research Ethics Boards

Moderator:
Pierre Geoffroy, MD, CM, MSc, F.C.F.P.
Medical Director – Principal Investigator
Biovail Contract Research

Dr. Hoda Eid
Manager
Health Canada
Health Products and Food Branch
Therapeutic Products Directorate
Office of Clinical Trials – Adverse Drug Reaction Unit

Laurel Evans
Associate Director, Research Ethics,
Office of Research Services
University of British Columbia
Past President and Public Affairs Committee
Canadian Association of Research Ethics Boards

Susan Zimmerman
Executive Director
Interagency Secretariat on Research Ethics (Ottawa)

• Changing norms on serious adverse event reporting
• Regulatory basis for Canadian clinical trial ADR reporting
• Options for addressing challenges in the management of adverse event reports in multi-centre clinical trials
• The 2nd edition of the TCPS and the role of the REB

2:45

Networking Refreshment Break

3:00

Strategies for Greater Web-Enabled Collaboration with the Patient

Rosa Deni
Training Account Leader
Eli Lilly and Company

Jason Ridderikhoff, B.Sc.N. 
Regional Operations Manager, Clinical Research
Eli Lilly Canada Inc.

This session will explore the potential of web-enabled technologies to increase collaboration between investigative sites and patients, including:

• Next generation ePRO devices
• Web-portals
• Hosted websites
• What’s next? A look into the future ...

3:45

Strategies to Retain Patients in Long-Term Clinical Trials

Sandra Smyth
Trial Delivery Director
AstraZeneca Canada Inc.

This presentation will focus on the challenges faced in patient retention in long-term trials, from the patient, investigator and sponsor perspective. Retention strategies to address these challenges and minimize patient loss from trials will also be examined and discussed.

4:30

Register 3 delegates for the main conference at regular price at the same time and you’re entitled to register a fourth person from your organization at no charge. For other group discounts, please call 1-888-777-1707. All discounts must be redeemed when booking, discounts will not be valid or applied after this time.