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2012 Sensible Guidelines Symposium: May 24-25 in Toronto, Ontario, Canada!

The goals of the 2012 Sensible Guidelines Symposium, which was jointly hosted by the Canadian Institute for Health Research (CIHR), were to debate and discuss study designs that could improve the efficiency of clinical trials, and to review emerging and existing barriers to the conduct of clinical trials. It was our hope that through these symposia and the ensuing publications, we can spur researchers and research stakeholders to work together to challenge the current environment. 

This meeting was organized by Professors Rory Collins, Christina Reith, Martin Landray, Colin Baigent (Oxford), Drs. Christopher Granger and Robert Califf (Duke), Dr. Jean Rouleau (CIHR), Drs. Salim Yusuf, PJ Devereaux, Jackie Bosch, Tara McCready (PHRI) and Dr. John Cairns (UBC).

Click here to download the agenda.  Attendees

To View or Download Speaker Bios, Slides, and Audio, please click:

Introduction: Salim Yusuf Slides Audio

Session I:  Ensuring Quality of Trials

What Matters in Terms of Clinical Trial Quality? David DeMets Slides Audio
Ensuring Quality: The Role of Monitoring Martin Landray Slides Audio
Is Our Current Approach to Adverse Event Reporting Sensible and Efficient? Patrick Archdeacon Slides Audio
Coping with Adverse Event Reporting: The Cancer Cooperative Group Experience Joe Pater Slides Audio
Research Ethics Board Harmonization Efforts in Canada Penny Moody-Corbett Slides Audio

Session II:  Obstacles to Trial Initiation and Conduct

Streamlining Regulatory Issues:  Achievements Thus Far and Challenges Ahead

Challenges from Recent International Trials

Jackie Bosch and

Jim Neaton





European Regulatory Perspective Fergus Sweeney Slides Audio
USA Regulatory Perspective Bob Temple Slides Audio
Industry Perspective Stephen Pyke Slides Audio

Special Regulatory Issues in Different Regions

China Lixin Jiang Slides Audio
South America Alvaro Avezum Slides Audio
India Prem Pais Slides Audio
Africa Trudie Lang Slides Audio
Japan Yasuhisa Fujii on behalf of Hideki Hanaoka Slides Audio

Privacy Issues and the Effect on Study Conduct

How Does Privacy Legislation Influence Screening, Recruitment, Follow-Up, and Even Documentation? Joe Pater Slides

Audio  Q&A

Is Privacy Legislation Really a Barrier to Research? Don Willison Slides Audio
Using Existing Databases to Identify and Contact Participants: Lessons from the ASCEND Study Louise Bowman Slides Audio
Onerous and Wasteful Practices Emanating from ICH GCP PJ Devereaux Slides Audio

Good Clinical Practices: How Can GCP be Modified to Have a More Sensible Approach?

GCP: Regulatory Perspective Ann Meeker-O'Connell Slides Audio
GCP: Industry Perspective Jeanne Varrone Slides Audio
GCP: Patient Perspective Nancy Roach Slides Audio
GCP: Academic Perspective Chris Granger Slides Audio

Session III:  Trial Designs that Maximize Efficiency: How Can We Ensure They Are Used More Often?

Pragmatic Trials: Why They Are Uncommon and Difficult to Implement David Sackett Slides Audio
Sensible Sub-Group Interpretation Guidelines Allow Factorial Designs Richard Peto Slides Audio
Additional Innovative Designs: Cluster Crossover Designs, Randomized Observational Trials; Links Between Registries and Trials, Use of Electronic Records Janice Pogue on behalf of John Eikelboom Slides Audio
Adaptive Designs: Are They Practical and Efficient? Janet Wittes Slides Audio

Conducting Trials In Special Circumstances

Emergent and Life-Threatening Situations Ian Roberts Slides Audio
Epidemics Laura Merson Slides Audio
Vulnerable Populations Trudie Lang Slides Audio


Major Outstanding Hurdles We Must Fix Within The Next 3-5 Years Rory Collins Slides Audio
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