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NEW INVESTIGATOR CLINICAL TRIALS COURSE
“FINAL PROGRAM”
August 21 - 23, 2013
Donald Gordon Centre
Queen’s University
Kingston Ontario
| Day 1 | Tuesday, August 20 2013 | ||
| 16:30 | Opening Remarks and Welcome Reception | ||
| 17:30 | Keynote Speaker: Clinical Research in the 21st Century: Evolving Paradigms for Clinical Trials | Janet Dancey | |
| 20:00 | Faculty Meeting/Dinner | ||
| Day 2 | Wednesday, August 21 2013 | ||
| 07:00 | Breakfast at Donald Gordon Centre | ||
| 09:00 | Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II | ||
| Prerequisites for Therapeutic Studies In Humans | Kim Chi | Objectives | |
| Phase I Trials | Lillian Siu | Objectives | |
| Phase II Trials | Elizabeth Eisenhauer | Objectives | |
| 10:30 | Break | ||
| 10:45 | Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III | ||
| Key Elements of a Successful Phase III Trial | Wendy Parulekar | Objectives | |
| Statistics for Clinical Trials Part I: Basics of Phase III Trial Design | Bingshu Chen | Objectives | |
| 12:00 | Lunch | ||
| 13:00 | Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy | Chris O'Callaghan | Objectives |
| Workshop 2: Phase II Design | Kim Chi Bernie Eigl |
Objectives | |
| Workshop 3: Correlative Studies in Clinical Trials | Ming Tsao Lois Shepherd |
Objectives | |
| 13:45 | Break | ||
| 14:00 | Workshop 4: Clinical Trials Infrastructure in Centres | Bernie Eigl | Objectives |
| Workshop 5: Practical Elements of Trial Development: Regulatory Standards and Contracts | Ralph Meyer | Objectives | |
| Workshop 6: Secondary Analyses and Mining of Clinical Trial Databases | Penny Bradbury Dongsheng Tu |
Objectives | |
| 14:45 | Break | ||
| 15:00 - 17:00 | Office Hours: 30 minutes one-on-one with a faculty member | ||
| 19:00 | Dinner (TBA) | ||
| Day 3 | Thursday, August 22 2013 | ||
| 07:00 | Breakfast at Donald Gordon Centre | ||
| 08:00 | Plenary session 3: Correlative Studies in Phase III Trials: Biomarkers | ||
| Design elements of biomarker studies | Janet Dancey | Objectives | |
| Laboratory aspects of biomarker studies | Ming Tsao | Objectives | |
| Statistical Analyses | Chris O'Callaghan | Objectives | |
| 10:00 | Break | ||
| 10:15 | Plenary Session 4: Correlative Science Studies in Phase III Trials | ||
| QoL | Jolie Ringash | Objectives | |
| Economic Evaluation | Nicole Mittmann | Objectives | |
| 12:00 | Lunch | ||
| 13:00 | Workshop 7: QOL Analysis | Jolie Ringash | Objectives |
| Workshop 8: Phase II Design (repeat) | Kim Chi Bernie Eigl |
Objectives | |
| Workshop 9: Practical Aspects of Tumour Banking | Lois Shepherd | Objectives | |
| 13:45 | Break | ||
| 14:00 | Workshop 10: Correlative Studies in Clinical Trials (repeat) | Ming Tsao Lois Shepherd |
Objectives |
| Workshop 11: Secondary Analyses and Mining of Clinical Trial Databases (repeat) | Penny Bradbury Dongsheng Tu |
Objectives | |
| Workshop 12: Practical Elements of Database Creation: Examples from the NCIC CTG casebook | Anna Sadura Elizabeth Eisenhauer |
Objectives | |
| 15:00 – 17:00 | Office Hours: 30 minutes one-on-one with a faculty member | ||
| 19:00 | Dinner (at your own leisure) | ||
| Day 4 | Friday, August 23 2013 | ||
| 07:00 | Breakfast at Donald Gordon Centre | ||
| 09:00 | NCIC CTG Overview: Structure and Opportunities for Investigators | Ralph Meyer | Objectives |
| 10:00 | NCIC CTG Collaborations: Academic, Regulatory and Industry | Jose Iglesias Norman Viner Jim Biagi |
Objectives |
| 11:00 | Panel Discussion: Mentorship in Academic Medicine | Jose Monzon Wendy Parulekar Jim Biagi |
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| 12:00 | Adjourn | ||
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