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Program Schedule

Workshop participants are required to attend the entire program and must attend all Lecture Sessions. Participants must arrive at the Vail Mountain Marriott Resort no later than 3:30 p.m. on Saturday, July 23 (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 28, after the last Workshop assignment is due. Departure is on Friday morning, July 29.

Program is subject to change.

Saturday, July 23

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

Sunday, July 24

  • 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
  • Special Lecture 1 
  • Office Hours 1: Protocol Related Questions
  • Independent Study Time
  • Reception / Dinner

Monday, July 25

  • 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
       • Special Considerations in the Design of Immunotherapy Studies
  • 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 / Dinner on Own
  • Optional Career Sessions
       • Topics to be selected following selection of participants
  • Independent Study Time / Dinner on Own

Tuesday, July 26

  • Continental Breakfast
  • Lecture Session 5
       • Navigating the National Clinical Trials Network
       • Patient-Reported Outcomes
       • Barriers to Accrual and How to Overcome Them
  • 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 Sessions
       • Topics to be selected following selection of participants
  • Independent Study Time / Dinner on Own

Wednesday, July 27

  • 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
       • Special Populations in Clinical Trials
  • Special Lecture 2
  • Protocol Development Group Session 5 / Lunch
  • Office Hours 3: Any Questions or Topics, including career related
  • Optional Networking Session
       • Women in Academia
  • Independent Study Time / Dinner on Own

Thursday, July 28

  • Continental Breakfast
  • Special Interest Sessions 1-3
       • Dose Selection for Oncology Drug Development
       • Cost-Effectiveness Analysis
       • Taking Your Product to Clinic
  • Lecture Session 9
       • Career Development Opportunities: The Government Can Help
       • Successful Grantsmanship
  • Break
  • Protocol Development Group Session 6
  • Administration of Post-test
  • Independent Study Time / Lunch
  • Reception / Banquet / Dance

Friday, July 29

  • Continental Breakfast
  • Departure

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Comments from 2015 Workshop Participants:

"I would like to thank all of you for making the Vail experience incredible for me. I truly appreciate everyone’s comments and suggestions to help my idea transform into a real, meaningful protocol. Before coming to Vail, I was quite nervous about how I could write a protocol just in 5 days. Now, I not only have a protocol, but have also learned a tremendous amount about clinical research, made new friends, …. This protocol "Boot Camp” is definitely a life changing experience!"

"This was an amazing experience - thank you so much for an incredible week!"

"I can't thank all of you enough for your efforts to improve this protocol. You demonstrated a sense of commitment to helping me activate this trial and reach my accrual goal. Thank you as well for your advice about pursuing an academic career in radiation oncology. I hope only that I can find mentors and colleagues as supportive and thoughtful as you wherever I eventually end up."

"I just wanted to say thank you so very much for all of the support and opportunity to participate in this phenomenal workshop. Words truly can't express how much I learned, and how appreciative I am to have had the opportunity to work with you all."

"Thank you very much for all of your wonderful advice and critiques this week. This was an invaluable experience and I will carry the lessons learned and friendships made here this week for the duration of my career."

"I also want to express my gratitude for your constructive feedback and all of your time and effort in reviewing our clinical trial designs, correlative studies, protocols, and consent documents. I really appreciate that you volunteered your time to help fellows like myself grow as clinical investigators. It is really inspiring!"

"Thank you very much for all your support and excellent mentoring over the course of the workshop. It was a really great and extremely productive week, with a lot of great ideas, teaching, mentoring and networking. All your input was invaluable in the process of developing my protocol."

"This was one of the most productive, useful, and educational weeks of my career."

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