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Biennial New Investigator Clinical Trials Course

August 21 - 23, 2024
Donald Gordon Hotel and Conference Centre
Queen's University
Kingston, Ontario
 

Program

Day 1 Wednesday, August 21, 2024 Room/Faculty
8:00am Welcome Conference Room A
Wendy Parulekar
8:00 - 8:10am Canadian Cancer Trials Group - Who Are We and Where Are We Going Conference Room A
Janet Dancey
8:10 - 8:30am Integrating EDIIA into Cancer Clinical Trials Conference Room A
Anna Johnson
8:30 - 10:30am Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II Conference Room A
  Prerequisites for Therapeutic Studies In Humans Anna Spreafico
  Phase I Trials Anna Spreafico
  Phase II Trials Wendy Parulekar
10:30 - 10:45am Break (refreshments and snacks) Donald Gordon Court
10:45 - 12:00pm Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III Conference Room A
  Key Elements of a Successful Phase III Trial Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Wei Tu
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 1 - 2 - 3  
  Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
  Workshop 2: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 3: Clinical Trials Regulations & Guidelines and Quality in Clinical Trials: How to Remain in Compliance Boardroom
Jessica Sleeth
Michelle Savoie
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 4 - 5 - 6  
  Workshop 4: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
  Workshop 5: Pre-Operative Surgical Trials in Drug Development Part 1
Pre-Operative Surgical Trials in Drug Development Part 2		 Boardroom
Tricia Cottrell
Pierre-Olivier Gaudreau
  Workshop 6: Platform Trials/Response Adaptive Trials: Overview of Design Elements Conference Room C
Laura Pearce
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 5:00pm Office Hours: 30 minutes one-on-one with a faculty member
sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
5:30 - 6:30pm Keynote Address: Patient Centric Clinical Trials: An overview of the CCTG Strategic and Scientific Agenda Conference Room A
Janet Dancey
6:30 pm Participant Dinner + Cash Bar Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 22, 2024 Room/Faculty
08:00 - 10:00am Plenary Session 3: Molecular Biomarkers in Clinical Trials Conference Room A
  Liquid Biopsies in Clinical Trials Scott Bratman
  Clinical Interpretation of Genomic Variants Peter Sabatini
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 12:00pm Plenary Session 4: Patient and Health Service Outcomes in Phase III Trials Conference Room A
  Patient-Reported Outcomes Joe Pater
  Economic Evaluation Annette Hay
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 7 - 8 - 9  
  Workshop 7: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 8: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Scott Bratman
Tricia Cottrell
  Workshop 9: Interim Analyses: Practical Considerations Boardroom
Greg Pond
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 10 - 11 - 12  
  Workshop 10: Platform Trials/Response Adaptive Trials: Overview of Design Elements Boardroom
Laura Pearce
  Workshop 11: Data Science in Clinical Trials: Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 12: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Scott Bratman
Tricia Cottrell
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 3:45pm Workshops 13 - 14  
  Workshop 13: Data Science in Clinical Trials: Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 14: Interim Analyses: Practical Considerations Conference Room A
Greg Pond
3:45 - 4:00pm    
4:00 - 5:30pm Office Hours: 30 minutes one-on-one with a faculty member
Sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
Evening Dinner (at your own leisure)  
Day 3 Friday, August 23, 2024 Room/Faculty
08:30 - 9:00am CCTG Overview: Opportunities for Engagement for Investigators Conference Room A
Kathy Han
Wendy Parulekar
09:00 - 9:30am Technological Advances in Clinical Trial Conduct: CCTG Perspective Conference Room A
Lam Pho
9:30 - 10:00am Data Sharing Opportunities for Investigators Conference Room A
Annette Hay
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 10:45am Patient Engagement Conference Room A
Yvonne Murray
10:45 - 11:45am New Investigator Collaborations and Interactions from an Industry Perspective
 Conference Room A
Marie-Christine Phan, Pfizer
Rudy Rizkalla, AstraZeneca
Valerie Chartrand, Merck
11:45 - 12:00pm Closing Remarks Conference Room A
Wendy Parulekar

CLOSED

Program

Day 1 Wednesday, August 21, 2024 Room/Faculty
8:00am Welcome Conference Room A
Wendy Parulekar
8:00 - 8:10am Canadian Cancer Trials Group - Who Are We and Where Are We Going Conference Room A
Janet Dancey
8:10 - 8:30am Integrating EDIIA into Cancer Clinical Trials Conference Room A
Anna Johnson
8:30 - 10:30am Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II Conference Room A
  Prerequisites for Therapeutic Studies In Humans Anna Spreafico
  Phase I Trials Anna Spreafico
  Phase II Trials Wendy Parulekar
10:30 - 10:45am Break (refreshments and snacks) Donald Gordon Court
10:45 - 12:00pm Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III Conference Room A
  Key Elements of a Successful Phase III Trial Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Wei Tu
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 1 - 2 - 3  
  Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
  Workshop 2: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 3: Clinical Trials Regulations & Guidelines and Quality in Clinical Trials: How to Remain in Compliance Boardroom
Jessica Sleeth
Michelle Savoie
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 4 - 5 - 6  
  Workshop 4: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
  Workshop 5: Pre-Operative Surgical Trials in Drug Development Part 1
Pre-Operative Surgical Trials in Drug Development Part 2		 Boardroom
Tricia Cottrell
Pierre-Olivier Gaudreau
  Workshop 6: Platform Trials/Response Adaptive Trials: Overview of Design Elements Conference Room C
Laura Pearce
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 5:00pm Office Hours: 30 minutes one-on-one with a faculty member
sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
5:30 - 6:30pm Keynote Address: Patient Centric Clinical Trials: An overview of the CCTG Strategic and Scientific Agenda Conference Room A
Janet Dancey
6:30 pm Participant Dinner + Cash Bar Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 22, 2024 Room/Faculty
08:00 - 10:00am Plenary Session 3: Molecular Biomarkers in Clinical Trials Conference Room A
  Liquid Biopsies in Clinical Trials Scott Bratman
  Clinical Interpretation of Genomic Variants Peter Sabatini
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 12:00pm Plenary Session 4: Patient and Health Service Outcomes in Phase III Trials Conference Room A
  Patient-Reported Outcomes Joe Pater
  Economic Evaluation Annette Hay
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 7 - 8 - 9  
  Workshop 7: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 8: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Scott Bratman
Tricia Cottrell
  Workshop 9: Interim Analyses: Practical Considerations Boardroom
Greg Pond
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 10 - 11 - 12  
  Workshop 10: Platform Trials/Response Adaptive Trials: Overview of Design Elements Boardroom
Laura Pearce
  Workshop 11: Data Science in Clinical Trials: Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 12: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Scott Bratman
Tricia Cottrell
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 3:45pm Workshops 13 - 14  
  Workshop 13: Data Science in Clinical Trials: Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 14: Interim Analyses: Practical Considerations Conference Room A
Greg Pond
3:45 - 4:00pm    
4:00 - 5:30pm Office Hours: 30 minutes one-on-one with a faculty member
Sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
Evening Dinner (at your own leisure)  
Day 3 Friday, August 23, 2024 Room/Faculty
08:30 - 9:00am CCTG Overview: Opportunities for Engagement for Investigators Conference Room A
Kathy Han
Wendy Parulekar
09:00 - 9:30am Technological Advances in Clinical Trial Conduct: CCTG Perspective Conference Room A
Lam Pho
9:30 - 10:00am Data Sharing Opportunities for Investigators Conference Room A
Annette Hay
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 10:45am Patient Engagement Conference Room A
Yvonne Murray
10:45 - 11:45am New Investigator Collaborations and Interactions from an Industry Perspective
 Conference Room A
Marie-Christine Phan, Pfizer
Rudy Rizkalla, AstraZeneca
Valerie Chartrand, Merck
11:45 - 12:00pm Closing Remarks Conference Room A
Wendy Parulekar

2022

Day 1 Wednesday, August 3, 2022 Room/Faculty
8:00am Welcome Conference Room A
Wendy Parulekar
8:00 - 8:10am Canadian Cancer Trials Group:
"Who Are We and Where Are We Going"		 Conference Room A
Janet Dancey
8:10 - 8:30am Patient Engagement in the Lifecycle of Clinical Trial Conference Room A
Judy Needham
8:30 - 10:30am Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II Conference Room A
  Prerequisites for Therapeutic Studies In Humans Rosalyn Juergens
  Phase I Trials Rosalyn Juergens
  Phase II Trials Wendy Parulekar
10:30 - 10:45am Break (refreshments and snacks) Donald Gordon Court
10:45 - 12:00pm Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III Conference Room A
  Key Elements of a Successful Phase III Trial Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Greg Pond
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 1 - 2 - 3  
  Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
Greg Pond
  Workshop 2: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 3: Clinical Trials Regulations & Guidelines and Quality in Clinical Trials: How to Remain in Compliance Boardroom
Michelle Savoie
Clive Hansen
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 4 - 5 - 6  
  Workshop 4: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room A
Chris O’Callaghan
Greg Pond
  Workshop 5: Pre-Operative Surgical Trials in Drug Development Part One  Part Two Boardroom
Wendy Parulekar
Tricia Cottrell
  Workshop 6: Platform Trials/Response Adaptive Trials: Overview of Design Elements Conference Room C
Janet Dancey
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 5:00pm Office Hours: 30 minutes one-on-one with a faculty member
sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
5:30 - 6:30pm Keynote Address: Integral Biomarkers in Clinical Trial Design and Conduct: The Experience of CCTG IND 234 Conference Room A
Alexander Wyatt
6:30 pm Participant Dinner + Cash Bar Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 4, 2022 Room/Faculty
08:00 - 10:00am Plenary Session 3: Molecular Biomarkers in Clinical Trials Conference Room A
  Liquid Biopsies in Clinical Trials Alexander Wyatt
  Clinical Interpretation of Genomic Variants Harriet Feilotter
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 12:00pm Plenary Session 4: Patient and Health Service Outcomes in Phase III Trials Conference Room A
  Patient-Reported Outcomes Michael Brundage
  Economic Evaluation Annette Hay
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 7 - 8 - 9  
  Workshop 7: Phase II Designs – Options and Practical Considerations Conference Room C
Wendy Parulekar
Wei Tu
  Workshop 8: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Harriet Feilotter
Tricia Cottrell
  Workshop 9: Interim Analyses: Practical Considerations Boardroom
Chris O’Callaghan
Greg Pond
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 10 - 11 - 12  
  Workshop 10: Platform Trials/Response Adaptive Trials: Overview of Design Elements John Deutsch
Janet Dancey
  Workshop 11: Data Science in Clinical Trials Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 12: When is a Biomarker Ready for Use in a Clinical Trial Conference Room A
Harriet Feilotter
Tricia Cottrell
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 3:45pm Workshops 13 - 14  
  Workshop 13: Data Science in Clinical Trials Fundamentals of Data Elements and Integration Conference Room C
Wei Tu
Lam Pho
  Workshop 14: Interim Analyses: Practical Considerations Conference Room A
Chris O’Callaghan
Greg Pond
3:45 - 4:00pm Break (refreshments and snacks) Donald Gordon Court
4:00 - 5:30pm Office Hours: 30 minutes one-on-one with a faculty member
Sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
Evening Dinner (at your own leisure)  
Day 3 Friday, August 5, 2024 Room/Faculty
08:30 - 9:00am CCTG Overview:Opportunities for Engagement for Investigators Conference Room A
Janet Dancey
09:00 - 9:30am Technological Advances in Clinical Trial Conduct Conference Room A
Lam Pho
9:30 - 9:45am Break (refreshments and snacks) Donald Gordon Court
9:45 - 10:15am Data Sharing Opportunities for Investigators Conference Room A
Annette Hay
10:15 - 11:15am New Investigator Collaborations and Interactions from an Industry Perspective Conference Room A
Zeshan Farooqui, Merck
Marie-Christine Phan, Pfizer
11:15 - 12:00pm Closing Remarks Conference Room A
Wendy Parulekar

2019

Day 1 Wednesday, August 7 2019 Room/Faculty
8:00 - 8:10am Canadian Cancer Trials Group:
"Who Are We" and "Where Are We Going"		 Conference Room A
Janet Dancey
8:10 - 8:30am Data Sharing Opportunities for Investigators Conference Room A
Annette Hay
8:30 - 10:30am Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II Conference Room A
  Prerequisites for Therapeutic Studies In Humans Philippe Bedard
  Phase I Trials Philippe Bedard
  Phase II Trials Wendy Parulekar
10:30 - 10:45am Break (refreshments and snacks) Donald Gordon Court
10:45 - 12:00pm Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III Conference Room A
  Key Elements of a Successful Phase III Trial Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Greg Pond
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 1 - 2 - 3  
  Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Conference Room C
Chris O’Callaghan
  Workshop 2: Phase II Design Boardroom
Wendy Parulekar
Greg Pond
  Workshop 3: Clinical Trial Regulations and Guidelines and Quality in Clinical Trials John Deutsch
Michelle Savoie
Clive Hansen
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 4 - 5 - 6  
  Workshop 4: Sample Size Determination, Methodology, Analysis and Philosophy John Deutsch
Chris O'Callaghan
  Workshop 5: Phase II Design Boardroom
Wendy Parulekar
Greg Pond
  Workshop 6: Clinical Trials Infrastructure in Centres Conference Room C
Andrew Robinson
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 5:00pm Office Hours: 20 minutes one-on-one with a faculty member
sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
5:30 - 6:30pm Keynote Address:
Toward Personalized Risk-Adapted Therapy for Oropharynx Cancer		 Conference Room A
Scott Bratman
6:30 pm Participant Dinner + Cash Bar Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 8 2019 Room/Faculty
08:00 - 10:00am Plenary Session 3: Correlative Science Studies in Phase III Trials Conference Room A
  Patient Reported Outcomes Michael Brundage
  Economic Evaluation Neil Reaume
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 12:00pm Plenary Session 4: Biomarkers in Clinical Trials Conference Room A
  Clinical Interpretation of Genomic Variants Harriet Feilotter
  Liquid Biopsies in Clinical Trials Dave Cescon
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshops 7 - 8 - 9  
  Workshop 7: Economic Evaluations Boardroom
Neil Reaume
  Workshop 8: Patient Reported Outcomes John Deutsch
Michael Brundage
  Workshop 9: Enabling Biomarker Testing in Clinical Trials Conference Room C
Harriet Feilotter
Lois Shepherd
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshops 10 - 11 - 12  
  Workshop 10: Economic Evaluations Boardroom
Neil Reaume
  Workshop 11: Patient Reported Outcomes John Deutsch
Michael Brundage
  Workshop 12: Design Elements of Statistical Analysis of Biomarker Data Conference Room C
Greg Pond
Bingshu Chen
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 3:45pm Workshops 13 - 14  
  Workshop 13: Design Elements of Statistical Analysis of Biomarker Data Conference Room C
Greg Pond
Bingshu Chen
  Workshop 14: Biomarker Studies in Clinical Trials - An Investigator Perspective Conference Room A
Dave Cescon
3:45 - 4:00pm Break (refreshments and snacks) Donald Gordon Court
4:00 - 5:30pm Office Hours: 20 minutes one-on-one with a faculty member
Sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
Evening Dinner (at your own leisure)  
Day 3 Friday, August 9 2019 Room/Faculty
08:30 - 9:00am CCTG Overview:Opportunities for Engagement for Investigators Conference Room A
Janet Dancey
09:00 - 9:30am Technological Advances in Clinical Trial Conduct Conference Room B
Lam Pho
9:30 - 9:45am Break (refreshments and snacks) Donald Gordon Court
9:45 - 10:15am Clinical Trial Design and the Real World: Efforts to Broaden Applicability Conference Room A
Wendy Parulekar
10:15 - 11:15am New Investigator Collaborations and Interactions from an Industry Perspective
Industry Academia Collaborations
New Investigator Collaborations and Interactions from an Industry Perspective
Partnering on Clinical Trials		 Conference Room A
Marc Zarenda, AstraZeneca
Tanya Irwin, Roche
Marie-Christine Phan, Pfizer
Daniel Martinez, Amgen
11:15 - 12:00pm Participant Feedback
Evaluation Form completion & receipt of CME Accreditation Certificate		 Registration Desk

2017

Day 1 Wednesday, August 9 2017 Room/Faculty
8:00 - 8:30am Canadian Cancer Trials Group:
"Who Are We" and "Where Are We Going"		 Conference Room B
Janet Dancey
8:30 - 10:30am Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II Conference Room B
  Prerequisites for Therapeutic Studies In Humans Albi Razak
  Phase I Trials Sarit Assouline
  Phase II Trials Wendy Parulekar
10:30 - 10:45am Break (refreshments and snacks) Donald Gordon Court
10:45 - 12:00pm Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III Conference Room B
  Key Elements of a Successful Phase III Trial Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Greg Pond
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshop 1: Conference Room A
  Sample Size Determination, Methodology, Analysis and Philosophy
Schulz & Grimes: Sample Size in RCT - The Lancet 2005		 Chris O’Callaghan
  Workshop 2: Conference Room C
  Phase II Design Francisco Vera-Badillo / Wendy Parulekar
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshop 3: Conference Room A
  Clinical Trials Infrastructure in Centres Andrew Robinson
  Workshop 4 Conference Room C
  Practical Elements of Trial Development: Regulatory Standards and Contracts Alison Urton
2:45 - 3:00pm Break (refreshments and snacks) Donald Gordon Court
3:00 - 5:00pm Office Hours: 20 minutes one-on-one with a faculty member
sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
5:30 - 6:30pm Keynote Address:
Patient Centred Research Overview		 Conference Room B
Janice Hodgson
6:30 pm Participant Dinner/Cash Bar Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 10 2017 Room/Faculty
08:00 - 10:00am Plenary Session 3: Correlative Science Studies in Phase III Trials Conference Room B
  Patient Reported Outcomes Michael Brundage
  Economic Evaluation Natasha Leighl
10:00 - 10:15am Break (refreshments and snacks) Donald Gordon Court
10:15 - 12:00pm Plenary Session 4: Biomarkers in Clinical Trials Conference Room B
  Design elements of clinical trials involving biomarkers Bingshu Chen
  Laboratory aspects of biomarker studies Harriet Feilotter
12:00 - 1:00pm Lunch Donald Gordon Dining Room
1:00 - 1:45pm Workshop 5: John Deutsch Room
  Update on Diagnostic Techniques in Cancer Medicine
Additional References		 Martin Chang
  Workshop 6: Boardroom
  Economic Evaluation Bingshu Chen / Natasha Leighl
  Workshop 7: Conference Room C
  Enabling Biomarker Testing in Clinical Trials: Key Information for External Investigators Lois Shepherd / David LeBrun>
1:45 - 2:00pm Break (refreshments and snacks) Donald Gordon Court
2:00 - 2:45pm Workshop 8: Conference Room A
  Patient Reported Outcomes Analysis Michael Brundage
  Workshop 9: Conference Room C
  Statistical Analysis of Biomarker Data Greg Pond
3:00 - 5:00pm Office Hours: 20 minutes one-on-one with a faculty member
Sign-up sheets are posted outside of Conference Room A		 Various Rooms
See sign up sheets
Evening Dinner (at your own leisure)  
Day 3 Friday, August 11 2017 Room/Faculty
08:30 - 9:55am CCTG Overview:
Structure and Opportunities for Investigators: How to Get Engaged		 Conference Room B
Janet Dancey
Tim Asmis
09:55 - 10:15am Data Sharing:
Opportunities for Investigators		 Conference Room B
Annette Hay
10:15 - 10:30am Break (refreshments and snacks) Donald Gordon Court
10:30 - 11:15am Health Canada - Clinical Trials Compliance Program Conference Room B
Adil Nashed
11:15 - 12:00pm New Investigator Collaborations and Interactions with Industry:
Trends in Clinical Trials Research from a Pharmaceutical Perspective		 Conference Room B
Marc Zarenda, AstraZeneca
Carrie Hamilton, Hoffmann-La Roche
Richard Plante, Janssen
12:00 pm Adjourn - Hand in Evaluation Form and receive CME Accreditation Certificate Registration Desk

2015

Day 1 Wednesday, August 12 2015    
8:30 Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II   Conference Room A
  Prerequisites for Therapeutic Studies In Humans Objectives Albi Razak
  Phase I Trials Objectives Penny Bradbury
  Phase II Trials Objectives Wendy Parulekar
10:30 Break    
10:45 Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III   Conference Room A
  Key Elements of a Successful Phase III Trial Objectives Chris O’Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Objectives Gary Clark
12:00 Lunch   Donald Gordon Dining Room
13:00 Workshop 1:   Conference Room C
  Sample Size Determination, Methodology, Analysis and Philosophy Objectives Chris O’Callaghan
13:00 Workshop 2:   Boardroom
  Phase II Design Objectives Dongsheng Tu / Wendy Parulekar
13:45 Break    
14:00 Workshop 3:   Boardroom
14:00 Clinical Trials Infrastructure in Centres Objectives Andrew Robinson
  Workshop 4   Conference Room C
  Practical Elements of Trial Development: Regulatory Standards and Contracts Objectives Alison Urton / Bryn Fisher
14:45 Break    
15:00-17:00 Office Hours: 30 minutes one-on-one with a faculty member
Office Hours sign-up sheets are posted outside of Conference Room A		   Various Rooms
See sign up sheets
17:30 Keynote Address:   Conference Room A
  The Clinical Utility of Large Population Cohorts in Precision Medicine   Philip Adawalla
18:30 Participant Dinner/Cash Bar   Donald Gordon Patio
(weather permitting)
Day 2 Thursday, August 13 2015    
08:00 Plenary Session 3: Correlative Studies in Phase III Trials: Biomarkers   Conference Room A
  Design elements of clinical trials involving biomarkers Objectives Gary Clark
  Laboratory aspects of biomarker studies Objectives Harriet Feilotter
10:00 Break    
10:15 Plenary Session 4: Correlative Science Studies in Phase III Trials   Conference Room A
  Quality of Life Measurement Objectives Alice Wei
  Economic Evaluation Objectives Natasha Leighl
12:00 Lunch   Donald Gordon Dining Room
13:00 Workshop 5:   Conference Room C
  QOL Analysis Objectives Dongsheng Tu / Alice Wei
  Workshop 6:   Boardroom
  Economic Evaluation Objectives Keyue Ding / Natasha Leighl
  Workshop 7:   John Deutsch
  Understanding your biomarker: what can this marker do for you Objectives Harriet Fielotter / John Bartlett
13:45 Break    
14:00 Workshop 8:   John Deutsch
  Understanding your biomarker: what can this marker do for you Objectives Harriet Fielotter / John Bartlett
  Workshop 9:   Boardroom
  Practical Aspects of Tumour Banking Objectives Shakeel Virk
  Workshop 10:   Conference Room C
  Statistical Analysis of Biomarker Data Objectives Gary Clark
15:00 - 17:00 Office Hours: 30 minutes one-on-one with a faculty member
Office Hours sign-up sheets are posted outside of Conference Room A		   Various Rooms
See sign up sheets
19:00 Dinner (at your own leisure)    
Day 3 Friday, August 14 2015    
08:30 Canadian Cancer Trials Group Overview   Conference Room A
  Structure and Opportunities for Investigators – panel of speakers of successful CTG career - Junior to mid. Objectives Wendy Parulekar / Investigator Panel
10:30 New Investigator Collaborations and Interactions: Regulatory and Industry   Conference Room A
  Regulatory   Alison Urton / Clive Hansen
  Industry   Industry Panel
12:00 Adjourn - Hand in Evaluation Form and receive CME Accreditation Certificate   Registration Desk

Comments from 2013 Course Attendees

  • The Canadian Cancer Trials Group provided a valuable course for fellows like myself at an early stage of subspeciality training. I plan on disseminating what i learned here to my fellow colleagues. Thank you for all your hard work in organizing a great educational course!
  • Thank you for this opportunity. Truly a wonderful learning experience. Congratulations to the organizing committee and all the great speakers who offered their time and expertise. Highly recommended!
  • This was a great course and i would recommenced to every New/Young Investigator.
  • Great course, very card card-body bg-light well prepared and instructive!
  • This is a brilliant advocacy of the Canadian Cancer Trials Group which is a very good opportunity for us fellows to learn what goes on before a clinical trial gets to the clinics.
  • I really enjoyed the course. Great topics, great set-up and very informative. All the faculty was card card-body bg-light well informed and motivated which motivates me to further undertake clinical trials.
Thank you to the following sponsors for the support provided for the 2013 New Investigator Clinical Trials Course:
Canadian Institutes of Health Research, Canadian Cancer Society Research Institute and Ontario Institute for Cancer Research

2013

Day 1 Wednesday, August 21 2013    
9:00 Plenary Session 1: Early Clinical Trials of Therapeutics: Phase I and II   Conference Room A
  Prerequisites for Therapeutic Studies In Humans Objectives Scott Laurie
  Phase I Trials Objectives Philippe Bedard
  Phase II Trials Objectives Penny Bradbury
10:30 Break    
10:45 Plenary Session 2:Comparative Efficacy Studies of Therapeutics: Phase III   Conference Room A
  The Canadian Cancer Trials Group CO.17, CO.20 & CO.23 Colon Cancer Studies: Examples of Successful Phase III Trials Objectives Chris O'Callaghan
  Statistics for Clinical Trials: Basics of Phase III Trial Design Objectives Bingshu Chen
12:00 Lunch   Donald Gordon Dining Room
13:00 Workshop 1:   Room 8
  Sample Size Determination, Methodology, Analysis and Philosophy Objectives Chris O'Callaghan
13:00 Workshop 2:   John Deutsch
  Phase II Design Objectives Penny Bradbury
Dongsheng Tu
13:45 Break    
  Clinical Trials Infrastructure in Centres Objectives Susan F. Dent
14:00 Workshop 4:   John Deutsch
  Practical Elements of Trial Development: Regulatory Standards and Contracts
Required Elements Checklist
Roles and Responsibilities		 Objectives Alison Urton
Wendy Parulekar
14:45 Break    
15:00-17:00 Office Hours: 30 minutes one-on-one with a faculty member Office Hours sign-up sheets are posted outside of Conference Room A    
17:30 Keynote Speaker / Participant Dinner   John Deutsch
  Keynote Address: Tips for Success in Translational Research   Fei-Fei Liu
Day 2 Thursday, August 22 2013    
08:00 Plenary Session 3: Correlative Studies in Phase III Trials: Biomarkers   Conference Room A
  Design elements of clinical trials involving biomarkers Objectives Gary Clark
  Laboratory aspects of biomarker studies Objectives Fei-Fei Liu
10:00 Break    
10:15 Plenary Session 4: Correlative Science Studies in Phase III Trials   Conference Room A
  QoL Objectives Harriet Richardson
  Economic Evaluation Objectives Natasha Leighl
12:00 Lunch   Donald Gordon Dining Room
13:00 Workshop 5:   Room 8
  QOL Analysis Objectives Harriet Richardson
Michael Brundage
13:00 Workshop 6:   Boardroom
  Economic Evaluation Objectives Natasha Leighl
13:45 Break    
14:00 Workshop 7:   Boardroom
  Statistical Analysis of Biomarker Data Objectives Gary Clark
  Workshop 8:   Boardroom
  Practical Aspects of Tumour Banking Objectives Lois Shepherd
14:45 Break    
15:00 - 17:00 Office Hours: 30 minutes one-on-one with a faculty member Office Hours sign-up sheets are posted outside of Conference Room A   Various Rooms See sign up sheets
19:00 Dinner (at your own leisure)    
Day 3 Friday, August 23 2013    
08:00 Canadian Cancer Trials Group Overview: Structure and Opportunities for Investigators   Conference Room A Wendy Parulekar
Annette Hay
09:00 New Investigator Collaborations and Interactions: Regulatory and Industry   Conference Room A Candice Hilder
Steve Atiyeh
10:00 Adjourn    

2011

Day 1 Tuesday, August 9 2011  
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 10 2011    
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 Objectives Lillian Siu
  Phase II Trials Objectives Elizabeth Eisenhauer
10:30 Break    
10:45 Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III    
  Key Elements of a Successful Phase III Trial Objectives Wendy Parulekar
  Statistics for Clinical Trials Part I: Basics of Phase III Trial Design Objectives Bingshu Chen
12:00 Lunch    
13:00 Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Objectives Chris O'Callaghan
  Workshop 2: Phase II Design Objectives Bernie Eigl
  Workshop 3: Correlative Studies in Clinical Trials Objectives Ming Tsao
Lois Shepherd
13:45 Break    
14:00 Workshop 4: Clinical Trials Infrastructure in Centres Objectives Bernie Eigl
  Workshop 5: Practical Elements of Trial Development: Regulatory Standards and Contracts Objectives Ralph Meyer
  Workshop 6: Secondary Analyses and Mining of Clinical Trial Databases Objectives

Penny Bradbury

Dongsheng Tu
14:45 Break    
15:00 - 17:00 Office Hours: 30 minutes one-on-one with a faculty member/td>    
19:00 Dinner (TBA)    
Day 3 Thursday, August 11 2011    
07:00 Breakfast at Donald Gordon Centre    
08:00 Plenary session 3: Correlative Studies in Phase III Trials: Biomarkers    
  Design elements of biomarker studies Objectives Janet Dancey
  Laboratory aspects of biomarker studies Objectives Ming Tsao
  Statistical Analyses Objectives Chris O'Callaghan
10:00 Break    
10:15 Plenary Session 4: Correlative Science Studies in Phase III Trials    
  QoL Objectives Jolie Ringash
  Economic Evaluation Objectives Nicole Mittmann
12:00 Lunch    
13:00 Workshop 7: QOL Analysis Objectives Jolie Ringash
  Workshop 8: Phase II Design (repeat) Objectives

Kim Chi

Bernie Eigl
  Workshop 9: Practical Aspects of Tumour Banking Objectives Lois Shepherd
13:45 Break    
14:00 Workshop 10: Correlative Studies in Clinical Trials (repeat) Objectives

Ming Tsao

Lois Shepherd
  Workshop 11: Secondary Analyses and Mining of Clinical Trial Databases (repeat) Objectives

Penny Bradbury

Dongsheng Tu
  Workshop 12: Practical Elements of Database Creation: Examples from the Canadian Cancer Trials Group casebook Objectives Elizabeth Eisenhauer
14:45 Break    
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 12 2011    
07:00 Breakfast at Donald Gordon Centre    
09:00 Canadian Cancer Trials Group Overview: Structure and Opportunities for Investigators Objectives Ralph Meyer
10:00 Canadian Cancer Trials Group Collaborations: Academic, Regulatory and Industry Objectives

Jose Iglesias

Norman Viner

Jim Biagi
11:00 Panel Discussion: Mentorship in Academic Medicine Objectives

Jose Monzon

Wendy Parulekar

Jim Biagi
12:00 Adjourn    

2009

Day 1 Tuesday, September 29 2009  
16:30 Opening Remarks and Welcome Reception Wendy Parulekar
17:30 Keynote Speaker : Clinical Research in Academic Medicine Ralph Meyer
20:00 Faculty Meeting/Dinner  
Day 2 Wednesday, September 30 2009  
07:00 Breakfast at Donald Gordon Centre  
09:00 Plenary Session 1: Phases of Clinical Development of Therapeutics: Phase I and II  
  Prerequisites for Therapeutic Studies Including Biomarkers Kim Chi
  Phase I Trials Lillian Siu
  Phase II Trials Elizabeth Eisenhauer
10:30 Break  
10:45 Plenary Session 2: Comparative Efficacy Studies of Therapeutics: Phase III    
  Phase III Trials: Key Elements of a Successful Phase III Trial N. Leighl
  Statistics for Clinical Trials Part I: Basics of Phase III Trial Design Bingshu Chen
12:00 Lunch    
13:00 Plenary Session 3: Phases of Clinical Development of Therapeutics: Phase III  
  Statistics for Clinical Trials Part II: Trial Analysis, Comparisons and Correlative Studies Chris O'Callaghan
13:45 Break  
14:00 Workshop 1: Sample Size Determination, Methodology, Analysis and Philosophy Chris O'Callaghan
  Workshop 2: Phase II Design Kim Chi
  Workshop 3: Correlative Studies in Clinical Trials Janet Dancey
14:45 Break    
15:00 Workshop 4: Clinical Trials Infrastructure in Centres Lillian Siu
  Workshop 5: Effective Presentations of Study Results Chris Booth
  Workshop 6: Secondary Analyses and Mining of Clinical Trial Databases Wendy Parulekar
16:00 Office Hours: 30 minutes one-on-one with a faculty member  
19:00 Dinner (Fort Henry)  
Day 3 Thursday, October 1 2009  
07:00 Breakfast at Donald Gordon Centre  
08:00 Plenary session 4: Special Topics in Clinical Trials  
  QOL Jolie Ringash
  Economic evaluation N.Leighl
  Biomarkers and laboratory aspects of correlative biology in clinical trials Jeremy Squire
10:00 Break  
10:15 Plenary session 5: Practical Elements of Trial Development: Examples from the Canadian Cancer Trials Group Casebook,/b>  
  Oversight of safety Elizabeth Eisenhauer
  International and Canadian standards Melanie Walker
  Contracts: negotiation and key elements Belinda Vandersluis
12:00 Lunch  
13:00 Workshop 7: QOL Analysis Jolie Ringash
  Workshop 8: Phase II Design (repeat) Kim Chi
  Workshop 9: Correlative Studies in Early Phase Trials (repeat) Janet Dancey
13:45 Break  
14:00 Workshop 10: Practical Aspects of Tumour Banking Lois Shepherd
  Workshop 11: Secondary Analyses and Mining of Clinical Trial Databases (repeat) Wendy Parulekar
  Workshop 12: Effective Presentations of Study Results (repeat) Chris Booth
15:00 - 17:00 Plenary session 6: Data Collection, Database and Analysis: Privacy, Security, Accuracy, Validity  
  Compilation of the trial database: CRFs and data checking Wendy Parulekar
  Database analysis and interpretation Bingshu Chen
16:00 Office Hours: 30 minutes one-on-one with a faculty member  
19:00 Dinner (at your own leisure)  
Day 4 Friday, October 2 2009  
07:00 Breakfast at Donald Gordon Centre  
09:00 Canadian Cancer Trials Group Overview: Structure and Opportunities for Investigators Ralph Meyer
10:00 Canadian Cancer Trials Group Collaborations: Academic, Regulatory and Industry

Ralph Meyer

Jose Iglesias
11:00 Panel Discussion: Mentorship in Academic Medicine

Penny Bradbury

Wendy Parulekar

T.Baetz
12:00 Adjourn  

2007

Day 1 Tuesday, August 28 2007  
16:30 Opening Remarks and Welcome Reception Elizabeth Eisenhauer
17:30 Keynote Speaker : Clinical Research in Academic Medicine Ralph Meyer
20:00 Faculty Meeting/Dinner  
Day 2 Wednesday, August 29 2007  
07:00 Breakfast at Donald Gordon Centre  
09:00 Plenary Session 1: Translating Laboratory Observations into the Clinic  
  Prerequisites for therapeutic studies Lesley Seymour
  Prerequisites for development of biomarker studies and other translational lab studies Lillian Siu
10:30 Break  
10:45 Plenary Session 2: Phases of Clinical Development of Therapeutics Phase I, II, III  
  Phase I trials Elizabeth Eisenhauer
  Phase II Trials Janet Dancey
  Phase III Trials Mark Levine
12:00 Lunch    
13:00 Workshop 1: Sample Size: Determination, Methodology, Analysis and Philosophy Mark Levine
  Workshop 2: Phase II Design Kim Chi
  Workshop 3: Correlative Studies in Early Phase Trials Ming Tsao
14:45 Break  
15:00 Plenary Session 3: Special Topics in Trial Design  
  Surrogate efficacy endpoints Wendy Parulekar
  Quality of life analysis Michael Brundage
  Economic evaluation Ana Johnson-Masotti
17:00 Dinner (Fort Henry)  
19:00 Office Hours: 30 minutes one-on-one with a faculty member  
Day 3 Thursday, August 30 2007  
07:00 Breakfast at Donald Gordon Centre  
08:00 Plenary session 4: Special Topics in Clinical Trials  
  Tumour banking Lois Shepherd
  Hypothesis generating studies/validation studies Janet Dancey
  Statistical analyses of correlative studies Chris O'Callaghan
10:00 Break  
10:15 Plenary session 5: Ethical, Legal and Regulatory Aspects of Clinical Trial Conduct  
  Oversight of safety Lesley Seymour
  International and Canadian standards

Lesley Seymour

Alison Urton
  Contracts: negotiation and key elements Belinda Vandersluis
12:00 Lunch  
13:00 Workshop 7: QOL Analysis Michael Brundage
  Workshop 2: Phase II Design (repeat) Kim Chi
  Workshop 3: Correlative Studies in Early Phase Trials (repeat) Lillian Siu
13:45 Break  
14:00 Workshop 8: Challenges in Design and Conduct of Prevention Studies Harriet Richardson
  Workshop 5: Clinical Trials Infrastructure in Centres (repeat) Kathleen Pritchard
  Workshop 6: Effective Presentations of Study Results (repeat) Kim Chi
15:00 - 17:00 Plenary session 6: Data Collection, Database and Analysis: Privacy, Security, Accuracy, Validity  
  Data collection Wendy Parulekar
  Database creation Lam Pho
  Database analysis and interpretation Chris O'Callaghan
17:00 Office Hours: 30 minutes one-on-one with a faculty member  
19:00 Dinner (at your own leisure)  
Day 4 Friday, August 31 2007  
07:00 Breakfast at Donald Gordon Centre  
09:00 Canadian Cancer Trials Group Overview

Ralph Meyer

Kathleen Pritchard
10:00 Canadian Cancer Trials Group Collaborations: Academic, Regulatory and Industry

Ralph Meyer

Kathleen Pritchard
11:00 Panel Discussion: Mentorship in Academic Medicine  
12:00 Adjourn