Conducting Clinical Trials in Canada
A Uniquely Canadian Perspective For all Clinical Research Professionals
June 2019 Agenda
8:00-8:30 Registration and Continental Breakfast (provided)
8:30-9:30: Strategies for Clinical Trial Patient Recruitment
Tim Hanas, President, Habit Creations, Inc.One of the most overlooked aspects of a clinical study is the patient recruitment strategy. A lack of participants can severely bottleneck your trial, so it’s important to have a clear plan of action to ensure adequate enrollment. Learn how you can apply Habit’s defined process using a blend of traditional and digital tools to significantly reduce recruitment timelines and demands on coordinators and other internal resources.
9:30-10:15: Investigator-Sponsored Trials: A Regulatory Perspective
Dana Nohynek, MsC, RAC, Director, Regulatory Affairs & Quality Assurance, CIHR Canadian HIV Trials Network / Centre for Health Evaluation & Outcome Sciences (CHEOS)
Investigator-sponsored research requires the same regulatory burden as trials sponsored by pharmaceutical or biotech companies. In many cases however, clinical research personnel have overlapping roles on behalf of the sponsor and investigator. Ms. Nohynek will focus on the challenges faced with investigator-sponsored studies in meeting Canadian regulatory requirements, and provide strategies for effective study conduct in achieving regulatory compliance.
10:30 -11:15: Health Canada’s Program and Application Process for Investigational Testing (Medical Device Clinical Trials)
Amanda Jones, MSc, Acting Manager, Investigational Testing and Special Access Programme Division, Medical Devices Bureau, Health Canada
Ms. Jones will provide an overview of the Investigational Testing and Special Assess Programme, which is governed by Canadian law in accordance with Part 3 of the Medical Devices Regulations (MDR). The presentation will include the 5 Ws (Who, What, Where, When, and Why), how to apply (including some important tips) and what to expect once your application is in. Ms. Jones will also review the most notable changes to the ITA Guidance document, which was updated in October 2018, along with an explanation on the timing and processes for REB approval letters. Ongoing process improvements and opportunities for future changes to our processes will also be discussed.
11:15-12:00: Let’s Get Practical about Patient Engagement with Clinical Research
Dawn Richards, PhD, Founder, Five02 Labs, Inc.
Dr. Richards will provide an overview of the concept of patient engagement with clinical research. Presented by a person who lives with rheumatoid arthritis and who works with organizations (nationally and internationally) to develop and execute patient engagement programs and projects, practical guidance will be provided via examples.
12:00-1:00: Lunch (provided)
1:00-2:00: Conducting Clinical Trials under the Tri-Council Policy Statement
Martin Letendre, LLB, LLM, President, ethica Group of Companies
Through this presentation, participants will be invited to look at the conduct of a Canadian multicenter clinical trial governed by the Tri-Council Policy Statement (TCPS) from both a Sponsor/CRO and a Site perspective. Participants will have the opportunity to identify how the TCPS requirements supplement ICH-GCP guidelines. The presentation will explore the TCPS from study conception, through study initiation, participant recruitment, study monitoring, and publication of study results.
2:00 – 2:15: Break
2:15 – 3:15: The Ontario SPOR Support Unit (OSSU) Experience: Enhancing and Enabling Patient Oriented Research in Ontario
Dean Fergusson, PhD, MHA, Director and Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute
Dr. Fergusson will introduce the topic of patient-oriented research and provide an overview of the OSSU vision and infrastructure for conducting patient-oriented research in Ontario. Specific emphasis will be placed on patient engagement in research and innovative pragmatic trials. Current examples of patient-oriented research will be provided to demonstrate the potential impact on practice and health outcomes.
3:15 -4:00: Illustrated Consent tool (ICT) – A novel way to optimize the informed consent process
Sarah Plamandon, Research Coordinator, The University of Ottawa Heart Institute
The ICT is visual aid presentation to help patients gain a better understanding the study material by using illustrations and colorful graphics. In this presentation you will learn:
- How to highlight the purpose of a study by using your own creativity
- Engage interest and conversation with the patient throughout the recruitment process.
- How to make recruiting fun!
8:15-8:30 Continental Breakfast (provided)
8:30-9:30: Health Canada’s New Guide-0100: Helping Researchers to Know the Rules! Follow the Rules!
Velma Marzinotto, RN, BScN, CCRP, Senior Research Compliance and Education Specialist, Providence St. Joseph’s St. Michael’s Healthcare
Health Canada has recently released GUIDE-0100 to help researchers conducting clinical drug trials to be compliant with regulations and guidelines, specifically Part C, Division 5 of the Food and Drug Regulations and ICH E6(R2). This talk will give an overview of the new GUIDE-0100. Methods to integrate Part C, Division 5 and ICH E6(R2) into practice to ensure compliance will be discussed.
9:30-10:30: Top 10 Mistakes Commonly Made When Drafting and Negotiating CTAs…What You Need to Know
Marlon Rajakaruna, BA, LLB, MBA, Partner, and National and Global Co-Chair of Dentons’ Life Sciences and Health Care groups
Negotiating a CTA is often a challenging task for CTA negotiators. This presentation will identify and describe key mistakes commonly made when drafting and negotiating CTAs. Topics covered will include CTAs with foreign sponsors, CTAs with CROs, privacy, indemnification, insurance and limitation of liability. For attendees not involved in CTA negotiations this presentation may still be of value, especially for study personnel who want to know if the CTA properly protects their interests.
10:45-12:00 ICH / GCP
Jacqueline Busheikin, CCRP, Independent CRA, JANA Research Consulting Inc
Ms. Busheikin will give an interactive presentation on core principles of ICH/GCP.
12:00-1:00 Lunch (provided)
1:00-2:00: Health Canada Trial Compliance Program
Shila Rastegar, MSc, Drug Specialist, Health Canada
2:00-3:00: International Trials - the Canadian Perspective
Rosemarie Clarke, BScN, MHM, RN, CCRP, CHE, Research Nurse Manager/Project Manager, University Health Network
3:15-4:00 Accreditation and its Influence on Research Sponsors and Funding Agencies
Janice Parente, PhD, President and CEO, Human Research Accreditation Canada
Dr. Parente will explore Canada's history of HRPP accreditation and how an organization with an accredited HRPP is more attractive to biomedical research sponsors.
- Current worldwide trends in biomedical research funding
- How Canada can increase its share of biomedical research funding through HRPP accreditation
4:00-4:15 Conference Wrap up and Q&A