New Investigator Clinical Trials Course

Biennial New Investigator Clinical Trials Course

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August 9 - 11, 2017
Donald Gordon Centre
Queen’s University
Kingston Ontario    

    The New Investigator Clinical Trials Course (NICTC) is an important component of the Canadian Cancer Trials Group mandate to provide and facilitate investigator education and training. The major goal of this three-day course is to familiarize new investigators from across the country with the essentials of clinical trial conduct in the Canadian research environment.

    The 2017 New Investigator Clinical Trials Course (NICTC) marks the sixth biennial year of the Course, which was founded in 2007. The next NICTC is scheduled for August 9 – 11, 2017. The course is held in Kingston, Ontario at the Donald Gordon Centre, which is a Queen’s University convention centre.

    Course Accreditation:

    The 2017 New Investigator Clinical Trials Course will be accredited for Maintenance of Competence (MOCOMP) credits with the Royal College of Physicians and Surgeons of Canada.

    Contact:

    For further information on the Canadian Cancer Trials Group Investigator Clinical Trials Course please contact:
    Anne Biggar
    Meetings and Committees Coordinator
    Canadian Cancer Trials Group
    613-533-6000 ext:77724
    abiggar@ctg.queensu.ca

     
     
    • Dr. Wendy Parulekar (Chair): Senior Investigator, Canadian Cancer Trials Group
    • Dr. Chris O'Callaghan: Senior Investigator, Canadian Cancer Trials Group
    • Dr. Annette Hay: Senior Investigator, Canadian Cancer Trials Group
    • Dr. Binghu Chen: Senior Biostatistician, Canadian Cancer Trials Group
    • Dr. Harriet Feilotter: Director, Molecular Diagnostics, Queen's University
    • Dr. Greg Pond: Statistician, Ontario Clinical Oncology Group
    • Dr. Laura Rodriguez: Fellow, Canadian Cancer Trials Group
    • Dr. Ketan Ghate: Resident, Cancer Centre of Southeastern Ontario at Kingston General Hospital
    • Dr. Osama Souied: Resident, Cancer Centre of Southeastern Ontario at Kingston General Hospital
    • Ms. Anne Biggar: Meeting Coordinator, Canadian Cancer Trials Group
    • Ms. Janice Flegg: Administrative Assistant, Canadian Cancer Trials Group
    Using lecture and interactive workshop formats, this course will provide an overview of clinical trial design and conduct for investigators in the field of cancer medicine. Topics will include the fundamentals of phase I-III clinical trial design, biostatistics in clinical trials, correlative biology, quality of life and economic evaluation in the research setting. Practical aspects of clinical trial conduct will also be addressed including how to set up a clinical trials unit, understanding and complying with national and international regulatory standards, contract negotiation, and career planning for the clinical trialist.
     
    The internationally recognized Course faculty will include senior investigators and managers from Canadian Cancer Trials Group Central Office as well as senior investigators from Canadian Cancer Trials Group Scientific Committees.

    Participants must be trainees/fellows and junior faculty members in their first five years of staff appointment in medical, hematologic, radiation and surgical oncology programs from across Canada.

    The Program Announcement is sent to the Canadian Cancer Trials Group Disease Site Committee Chairs / Co-Chairs, Directors of Residency Programs in the oncology disciplines across Canada, as well as the professional associations of each subspecialty (Canadian Association of Medical Oncologists, Canadian Association of Radiation Oncologists, Canadian Oncology Societies).

    Applicants are asked to provide a current curriculum vitae and their research interests as they relate to clinical trials, and to provide feedback on the draft agenda and suggestions for additional topics. The selection process will be based on the need for broad representation of the different subspecialties, and geographical distribution from across Canada.

    Successful applicants will receive funding support from the Canadian Cancer Trials Group for travel and accommodation. Course material including faculty biographies, presentations, and session bibliographies will be made available to course participants on the Canadian Cancer Trials Group website.

     2017 Workshop Sign-Up Form - Coming Soon

     Expense Claim Form (coming soon)

     CME Accreditation

    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 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 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 Phil 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
    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  
    • For information on how to Sponsor the NICTC please contact:
      Anne Biggar at abiggar@ctg.queensu.ca or 613-533-6430