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Program

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 3:00 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 4:00 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 Pretest
  • Welcome and Overview
  • Protocol Development Group Session I / 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
  • Lecture Session 2
       • Principles of Clinical Pharmacology
       • Phase II Trials
       • Novel Phase II Designs
  • Protocol Development Group Session 2 / Lunch
  • Office Hours 1: Protocol Related Questions
  • Independent Study Time
  • ASSIGNMENT DUE: PROTOCOL SYNOPSIS SHEETS
  • 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
  • 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 in Clinical Trials
  • Small Group Discussion Sessions 3-4
       • Inflammatory and Immunologic Biomarkers
       • Laboratory Correlates
  • Independent Study Time / Dinner on Own
  • ASSIGNMENT DUE: STATISTICAL SECTION

Tuesday, July 28

  • Continental Breakfast
  • Lecture Session 5
       • Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups
       • Quality of Life and Survivorship
  • Break / Group Photo
  • Protocol Development Group Session 4 / Lunch
  • 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)
  • Office Hours 2: Protocol Related Questions
  • Independent Study Time / Dinner on Own
  • ASSIGNMENT DUE: PROTOCOL DRAFT

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
  • Lecture Session 7
       • Panel Discussion: Special Populations in Clinical Trials
  • Protocol Development Group Session 5 / Lunch
  • Special Interest Group and Career Sessions
       • Surgery and Surgery-related Specialties
       • Radiation Oncology
       • Pediatric Oncology
       • Becoming a Phase I Investigator
  • Office Hours 3: Any Questions or Topics, including career related
  • Independent Study Time / Dinner on Own
  • Optional Session
       • Women in Academia
  • ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS

Thursday, July 30

  • Continental Breakfast
  • Lecture Session 8
       • Career Development Opportunities: The Government Can Help
       • Successful Grantsmanship
  • Protocol Development Group Session 6
  • Administration of Posttest
  • Lunch
  • Independent Study Time
  • ASSIGNMENT DUE: FINAL PROTOCOL, INFORMED CONSENT DOCUMENTS, WORKSHOP EVALUATIONS
  • Reception / Banquet / Dance

Friday, July 31

  • Continental Breakfast
  • Departure
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Comments from 2013 Workshop Participants:

"This one week will probably teach me more than I can ever gain from my 3 years fellowship everything I will need from job hunt to getting grants / writing research protocols, etc."

"This workshop has been a career defining moment in my life. It has provided me with valuable collaborative opportunities amongst peers, mentorship opportunities amongst faculty members and --- my curiosity in clinical trials."

"Outstanding opportunity. I felt like the faculty were personally invested in my success."

"The workshop has cemented my interest in an academic career. It was an amazing mentorship program to us and made me overall excited about my research."

"This course should be required for every fellow. The highlight of my fellowship so far. The faculty was inspiring (as were the participants)."

"(The faculty) went above and beyond any expectation in mentoring me during this workshop. Their passion for teaching mentoring and development for therapeutics is infectious and pushes me to take things to the next level."

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