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 |
| PANEL DISCUSSION: QUALITY IN CLINICAL TRIALS | 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 |
||
| 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 |
| PANEL DISCUSSTION: | STREAMLINING REGULATORY ISSUES | Audio |
Privacy Issues and the Effect on Study Conduct
| How Does Privacy Legislation Influence Screening, Recruitment, Follow-Up, and Even Documentation? | Joe Pater | Slides | |
| 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 |