Tentative Daily Program
Participants should plan to arrive at the Vail Marriott Mountain Resort no later than 3:00 p.m. on Saturday, August 7.
The Workshop will begin with a mandatory pretest at 4:00 p.m.
A closing reception and banquet will be held on Thursday evening, August 12, after the last Workshop assignment is due.
Departure should be scheduled for Friday, August 13..
Saturday, August 7, 2010
12:00 noon - 4:00 p.m. . .Registration
Afternoon (beginning at 4.00 p.m.)
- Administration of Pretest
- Welcome & Course Overview
- Protocol Development Session I
- Dinner
Sunday, August 8, 2010
Morning
- Statistical Considerations in Protocol Development
- Elizabeth Garrett-Mayer, Medical University of South Carolina, Charleston, SC
- Design and Analysis of Phase I Clinical Trials in
Cancer Therapy
- Gary K. Schwartz, Memorial Sloan-Kettering Cancer Center, New York, NY
- Novel Statistical Designs in Phase I Studies
- Richard J. Chappell, The University of Wisconsin, Madison, WI
- Panel and Questions: Phase I Trials and Designs
- Elizabeth Garrett-Mayer, Medical University of South Carolina, Charleston, SC
- Gary K. Schwartz, Memorial Sloan-Kettering Cancer Center, New York, NY
- Richard J. Chappell, The University of Wisconsin, Madison, WI
- Phase II Trials
- Miguel A. Villalona-Calero, The Ohio State University Medical Center, Columbus, OH
- Novel Phase II Designs
- Yu Shyr, Vanderbilt University, Nashville, TN
- Principles of Clinical Pharmacology
- Merrill J. Egorin, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- Panel and Questions: Phase II Trials and Designs
- Miguel A. Villalona-Calero, The Ohio State University Medical Center, Columbus, OH
- Yu Shyr, Vanderbilt University, Nashville, TN
- Merrill J. Egorin, University of Pittsburgh Cancer Institute, Pittsburgh, PA
Afternoon
- Protocol Development Session II
- Office Hours
Evening
- Assignment Due: Protocol Concept Synopsis Sheets
- Reception/Buffet Dinner
Monday, August 9, 2010
Morning
- Incorporation of Biological Correlative Studies into Early Clinical Trials
- Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
- Statistical Aspects of Correlative Studies
- Mithat Gonen, Memorial Sloan-Kettering Cancer Center, New York, NY
- Feasibility & Reproducibility Issues
- Angelo M. DeMarzo, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
- Panel and Questions: Biomarker Issues
- Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
- Mithat Gonen, Memorial Sloan-Kettering Cancer Center, New York, NY
- Angelo M. DeMarzo, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
- Protocol Development Session III
Afternoon
- Radiation Oncology Trials Alone and in Multimodality Settings
- Charles R. Thomas, Jr., OHSU Cancer Center Hospital, Portland, OR
- Imaging in the Era of Targeted Therapy
- Richard L. Wahl, Johns Hopkins Outpatient Center, Baltimore, MD
Small Group Discussion Sessions
- Choosing Appropriate Clinical Endpoints
- Neal J. Meropol University Hospitals Case Medical Center & Case Western Reserve University, Cleveland, OH
- Miguel A. Villalona-Calero, The Ohio State University Medical Center, Columbus, OH
- Vivian Weinberg, University of California, San Francisco, CA
- Mary Scroggins, In My Sister's Care, Washington, DC
- Imaging Endpoints in Clinical Trials
- Richard L. Wahl, Johns Hopkins Outpatient Center, Baltimore, MD
- Mithat Gonen, Memorial Sloan-Kettering Cancer Center, New York, NY
- Measuring Immunologic Outcomes
- Mary L. Nora Disis, University of Washington, Seattle, WA
- Heidi L. Weiss, UT Medical Branch, Galveston, TX
- Laboratory Correlates
- Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute, Detroit, MI
- Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
- Angelo M. DeMarzo, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
- Vera J. Suman, Mayo Clinic College of Medicine Cancer Center, Statistics Unit, Rochester, MN
Evening
- Assignment Due: Statistical Section Draft
Tuesday, August 10, 2010
Morning
- Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups
- Neal J. Meropol, University Hospitals Case Medical Center & Case Western Reserve University, Cleveland, OH
- Quality of Life and Survivorship
- Jamie H. Von Roenn, Northwestern University School of Medicine, Chicago, IL
- Protocol Development Session IV
Afternoon
- Special Populations in Clinical Trials – Panel Discussion
- Gregory H. Reaman, Children's Oncology Group, Bethesda, MD
- Vicki A. Morrison, University of Minnesota VA Medical Center, Minneapolis, MN
- Westley Sholes, Sholes & Associates, Rancho Palos Verdes, CA
- Office Hours
- Time for Independent Study/Tutorials
Evening
- Assignment Due: Protocol Drafts
Wednesday, August 11, 2010
Morning
- Everything You Need To Know About Clinical Trail Ethics and Informed Consent: A Case History
- Stacey L. Berg, Texas Children's Cancer Center at Baylor College of Medicine, Houston, TX
- Neal J. Meropol, University Hospitals Case Medical Center & Case Western Reserve University, Cleveland, OH
- Mary Scroggins, In My Sister's Care, Washington, DC
- You’re in Charge: Investigator Responsibilities
- Merrill J. Egorin, University of Pittsburgh Cancer Institute, Pittsburgh, PA
- Protocol Development Session V
Afternoon
Lunch – Special Interest Group and Career Sessions
(optional)
- Surgical and Surgery-related Specialties
- Lee M. Ellis, UT M. D. Anderson Cancer Center, Houston, TX
- Anil K. Sood, UT M. D. Anderson Cancer Center, Houston, TX
- Pediatric Oncology
- Charles R. Thomas, OHSU Cancer Center Hospital, Portland, OR
- A. William Blackstock, Wake Forest University, Winston Salem, NC
- Radiation Oncology
- Gregory H. Reaman, Children's Oncology Group, Bethesda, MD
- Stacey L. Berg, Texas Children's Cancer Center at Baylor College of Medicine, Houston, TX
- Becoming a Phase I Investigator
- Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute, Detroit, MI
- Office Hours
Small Group Discussion Sessions
- First in Human Phase I Trials: Understanding the Regulatory Process
- Larry Kessler, University of Washington, Seattle, WA
- Sandra J. Horning, Genentech, Inc., San Francisco, CA
- Written and Oral Research Presentations That Audiences Remember
- Margaret Foti, American Association for Cancer Research, Philadelphia, PA
- Lee M. Ellis, UT M. D. Anderson Cancer Center, Houston, TX
- Training Grants and Mentoring
- Ming Lei, National Cancer Institute, N. Bethesda, MD
- Mary L. (Nora) Disis, University of Washington, Seattle, WA
- Judith E. Karp, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, MD
Evening
- Assignment Due: Informed Consent Document (Draft)
Thursday, August 12, 2010
Morning
- Career Development Opportunities: The Government Can Help
- Ming Lei, National Cancer Institute, N. Bethesda, MD
- Successful Grantsmanship
- Mary L. (Nora) Disis, University of Washington, Seattle, WA
- Panel and Questions: Careers and Grants
- Ming Lei, National Cancer Institute, N. Bethesda, MD
- Protocol Development Session VI
Afternoon
- Administration of Posttest
- Independent Study/Work on Protocols
Evening
- Assignment Due: Final Protocols/Informed Consent Forms/Course Evaluation Forms
- Reception/Banquet/Dance
Friday, August 13, 2010
Continental Breakfast/Departure