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Program

 

Daily Program
Participants should plan to arrive at the Vail Marriott Mountain Resort no later than 3:00 p.m. on Saturday,August 2. 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 7, after the last Workshop assignment is due. The Workshop will adjourn after breakfast on Friday, August 8.

Saturday, August 2, 2008
12:00 noon - 8:00 p.m. . .Registration
4:00 - 5:00 p.m. . . . . . . .Administration of Pretest
5:00 - 5:15 p.m. . . . . . . .Welcome & Course Overview
5:15 - 6:00 p.m. . . . . . . .Keynote Lecture
6:00 - 7:45 p.m. . . . . . . .Protocol Development Session I
7:45 - 9:15 p.m. . . . . . . .Barbecue Buffet Dinner

Sunday, August 3, 2008
8:00 - 10:15 a.m. . . . . . . .Lecture Session I

  • Introduction
  • Design and Analysis of Phase I Clinical Trials in Cancer Therapy
  • Phase II Trials
  • Basic Biostatistics for the Clinical Trialist I

10:30 a.m. - 12:35 p.m. .Lecture Session II

  • Basic Biostatistics for the Clinical Trialist II
  • Principles of Clinical Pharmacology
  • Incorporation of Biological Correlative Studies into Early Clinical Trials

12:45 - 2:45 p.m. . . . . . . .Protocol Development Session II
3:00 - 5:00 p.m. . . . . . . . .Office Hours
5:00 - 6:00 p.m. . . . . . . . .Special Interest Group Sessions (Surgical & Gynecological; Radiation; Pediatric)
7:00 p.m. . . . . . . . . . . . . Protocol Concept Sheets Due
7:00 p.m. . . . . . . . . . . . . .Reception/Buffet Dinner

Monday, August 4, 2008
8:00 - 9:25 a.m. . . . . . . . .Lecture Session III

  • Everything You Need To Know About Clinical Trial Ethics and Informed Consent: A Case History

9:45 - 11:05 a.m. . . . . . . .Lecture Session IV

  • Novel Phase II Designs
  • Imaging in the Era of Targeted Therapy

11:15 a.m. - 12:45 p.m. .Protocol Development Session III
12:45 - 1:30 p.m. . . . . . .Buffet Lunch
2:00 - 3:30 p.m. . . . . . . .Small Group Discussion Sessions

  • Choosing Appropriate Clinical Endpoints
  • Imaging Endpoints in Clinical Trials
  • Measuring Immunologic Outcomes
  • Laboratory Correlates

3:30 p.m. - Evening . . . . . .Work on Protocols; Dinner on your own

Tuesday, August 5, 2008
8:00 - 9:20 a.m. . . . . . . . .Lecture Session V

  • Radiation Oncology Trials Alone and in Multimodality Settings
  • Patient Reported Outcomes

10:00 - 11:20 a.m. . . . . . .Lecture Session VI

  • Special Populations in Clinical Trials – Panel Discussion

11:30 a.m. - 1:30 p.m. . . .Protocol Development Session IV
1:45 - 3:00 p.m. . . . . . . . .Office Hours
3:00 p.m. . . . . . . . . . . . . .Open Time/Time for Independent Study/Tutorials
Evening . . . . . . . . . . . . . .Dinner on your own
9:00 p.m. . . . . . . . . . . . . .Protocol Drafts Due

Wednesday, August 6, 2008
8:00 -10:30 a.m. . . . . . . .Lecture Session VII

  • Cancer Chemoprevention
  • Putting the Novelty Back in Phase II Trials
  • Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups
  • You’re in Charge: Investigator Responsibilities
  • Primer in Regulatory Oncology

10:45 a.m. - 12:15 p.m. . Protocol Development Session V
12:15 - 1:00 p.m. . . . . . Lunch
1:00 - 2:30 p.m. . . . . . . Small Group Discussion Sessions

  • Choosing Appropriate Clinical Endpoints
  • Laboratory Correlates
  • What You Can Learn from 'Omics
  • Training Grants and Mentoring

2:45 - 4:15 p.m. . . . . . . .Office Hours
4:15p.m. . . . . . . . . . . . .Open Time/Work on Protocols
7:00 p.m. . . . . . . . . . . . .Informed Consent Document (Draft) Due
Evening . . . . . . . . . . . . .Work on Protocols; Dinner on your own

Thursday, August 7, 2008
8:00 - 11:00 a.m. . . . . . . . .Lecture Session VIII

  • Career Development Opportunities: The Government Can Help
  • Successful Grantsmanship
  • Written and Oral Research Presentations That Audiences Remember

11:00 a.m. - 12:15 p.m. . . .Protocol Development Session VI
12:15 - 1:00 p.m. . . . . . . Buffet Lunch
1:00 - 2:00 p.m. . . . . . . .Administration of Posttest
2:00 - 7:00 p.m. . . . . . . .Work on Protocols
7:00 p.m. . . . . . . . . . . . .Final Protocols/Informed Consent Forms Due
7:00 p.m. . . . . . . . . . . . .Reception/Banquet/Dance

Friday, August 8, 2008
6:00 - 8:00 a.m. . . . . . . . .Continental Breakfast/Departure

(Workshop topics and schedule subject to change.)