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Tentative Daily Program

Applicants selected to attend the Workshop must attend the entire program. Applicants unable to participate over the dates of the Workshop as outlined below, should apply next year.

Participants must arrive at the Vail Mountain Marriott Resort no later than 3:30 p.m. on Saturday, July 25 (Vail is approximately 2-3 hours from Denver International Airport). The Workshop will begin with a mandatory pretest at 5:00 p.m. A closing reception and banquet will be held on Thursday evening, July 30, after the last Workshop assignment is due. Departure is on Friday morning, July 31.

Program is subject to change

Saturday, July 25

  • Registration
  • Administration of Pre-test
  • Welcome and Workshop Overview
  • Protocol Development Group Session 1 / Dinner

Sunday, July 26

  • Continental Breakfast
  • Lecture Session 1
       • Statistical Considerations in Protocol Development: From Hypothesis to Analysis
       • Design and Analysis of Phase I Clinical Trials in Cancer Therapy
       • Novel Statistical Designs in Phase I Studies
  • Break
  • Lecture Session 2
       • Principles of Clinical Pharmacology
       • Phase II Trials
       • Novel Phase II Designs
  • Lunch
  • Protocol Development Group Session 2
  • Office Hours 1: Protocol Related Questions
  • Independent Study Time
  • Reception / Dinner

Monday, July 27

  • Continental Breakfast
  • Lecture Session 3
       • Incorporation of Biological Correlative Studies into Early Clinical Trials
       • Feasibility and Reproducibility in Biomarker Studies
       • Statistical Aspects of Correlative Studies
       • ‘Omics’ Platform Considerations in Clinical Trials
  • Break
  • Lecture Session 4
       • Imaging in the Era of Targeted Therapy
       • Taking Your Product to Clinic
       • Barriers to Accrual and How to Overcome Them
  • Protocol Development Group Session 3
  • Lunch
  • Small Group Discussion Sessions 1-2
       • Choosing Appropriate Clinical Endpoints
       • Imaging Endpoints
  • Small Group Discussion Sessions 3-4
       • Inflammatory and Immunologic Biomarkers
       • Laboratory Correlates
  • Independent Study Time
  • Optional Sessions
       • Careers in Radiation Oncology
       • Careers in Hematological Malignancies
  • Independent Study Time / Dinner on Own

Tuesday, July 28

  • Continental Breakfast
  • Lecture Session 5
       • Navigating the National Clinical Trials Network
       • Quality of Life and Survivorship
  • Small Group Discussion Sessions 5-7
       • First in Human Trials: Understanding the Regulatory Process
       • Written and Oral Research Presentations That Audiences Remember
       • Work-Life Balance (for both men and women)
  • Break / Group Photo
  • Protocol Development Group Session 4
  • Lunch
  • Office Hours 2: Protocol Related Questions
  • Optional Career Session
       • Careers in Industry
  • Independent Study Time / Dinner on Own

Wednesday, July 29

  • Continental Breakfast
  • Lecture Session 6
       • Everything You Need To Know About Clinical Trial Ethics and Informed Consent: A Case History
       • You’re In Charge: Investigator Responsibilities
  • Break
  • Lecture Session 7
       • Panel Discussion: Special Populations in Clinical Trials
  • Forum
       • Becoming a Phase I Investigator
  • Lunch
  • Protocol Development Group Session 5
  • Office Hours 3: Any Questions or Topics, including career related
  • Optional Networking Session
       • Women in Academia
  • Independent Study Time / Dinner on Own

Thursday, July 30

  • Continental Breakfast
  • Special Interest Sessions
       • Special Considerations in the Design of Immunotherapy Studies
       • Dose Selection for Oncology Drug Development
  • Lecture Session 8
       • Career Development Opportunities: The Government Can Help
       • Successful Grantsmanship
  • Break
  • Protocol Development Group Session 6
  • Administration of Post-test
  • Lunch
  • Independent Study Time
  • Reception / Banquet / Dance

Friday, July 31

  • Continental Breakfast
  • Departure

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Comments from 2014 Workshop Participants:

"The involvement and dedication of the faculty is outstanding."

"One of the best experiences of my fellowship years. I have grown substantially professionally through this experience."

"Great program and very helpful for protocol development and career development."

"OUTSTANDING – life changing. A workshop like this can change a career…."

"I don’t know how I would have ever understood clinical trial design this well without this (Workshop)."

"One of the best networking experiences of my career (actually the best networking experience!)."

"Amazing experience, amazingly dedicated faculty."