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Program-2018

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 4:00 p.m. on Saturday, July 28 (Vail is approximately 2-3 hours from Denver International Airport). The Workshop will begin promptly at 5:00 pm. A closing reception and banquet will be held on Thursday evening, August 2, after the last Workshop assignment is due. Departure is on Friday morning, August 3.


SATURDAY, JULY 28, 2018

Shuttles from Denver International Airport (11:30 am-2:00 pm / 12:30 pm-3:00 pm / 1:15 pm-3:45 pm)

Registration (1:30 pm-6:00 pm)

Welcome/Overview (5:00 pm-5:30 pm)

Protocol Development Group Session 1 / Buffet Dinner (5:30 pm-8:30 pm)


SUNDAY, JULY 29, 2018

Breakfast (7:00 am-8:00 am)

Lecture Session 1 (8:00 am-9:50 am)
: Clinical Trial Design: Asking Important Questions that Impact Our Patients - Jyoti D. Patel
: Answering Important Questions: From Hypothesis to Analysis - Meredith M. Regan
: Phase 1 Trial Questions - Patricia M. LoRusso
: Phase 1 Trial Designs - Thomas Braun

Break (9:50 am-10:05 am)

Lecture Session 2 (10:05 am-12:05 am)
: Phase 2 Trial Questions/Objectives - Michael A. Carducci
: Phase 2 Trial Designs - Mary Redman
: Dose Selection for Oncology Drug Development - Tatiana M. Prowell and Chris H. Takimoto
: Combination and Multimodality Trials: Many Variables but One Question - Karyn A. Goodman and Stuart G. Lutzker

Protocol Development Group 2 / Lunch (12:15 pm-3:00 pm)

Independent Study Time (3:00 pm-7:30 pm)

Office Hours 1 (Biostatisticians Only) (3:15 pm-615 pm)

ASSIGNMENT DUE: PROTOCOL TEMPLATE (7:30 pm)

Dinner (7:30 pm-9:30 pm)


MONDAY, JULY 30, 2018

Breakfast (7:00 am-8:00 am)

Special Lecture (7:30 am-8:15 am)
 :Career Development Oppotunities: The Government Can Help - Susan N. Perkins

Lecture Session 3 (8:25 am-10:25 am)
: Feasibility and Reproducibility in Biomarker Studies - Kurt A. Schalper
: Incorporation of Biological Correlative Studies into Early Clinical Trials - Timothy A. Yap
: Statistical Aspects of Correlative Studies - Wendy B. London
: Panel Discussion / Q&A - Deborah E. Collyar, Wendy B. London, Kurt A. Schalper, and Timothy A. Yap

Break (10:25 am-10:40 am)

Lecture Session 4 (10:40 am-12:10 pm)
: Imaging in the Era of Targeted Therapy and Immunotherapy - Thomas E. Yankeelov
: Special Considerations in the Design of Immunotherapy Studies - Roy S. Herbst
: Inflammatory and Immunologic Biomarkers - Mary L. Disis
: Panel Discussion / Q&A - Mary L. Disis, Roy S. Herbst, Josh Mailman, Byung S. Park, and Thomas E. Yankeelov

Protocol Development Group Session 3 / Lunch (12:15 pm-3:30 pm)

Office Hours 2: Protocol Related Questions (3:40 pm-5:40 pm)

Independent Study Time / Dinner (5:40 pm-8:30 pm)

ASSIGNMENT DUE: STATISTICAL SECTION (8:30 pm)


TUESDAY, July 31, 2018

Breakfast (7:00 am-8:00 am)

Small Group Discussion Sessions 1-2 (8:00 am-9:00 am)
: First in Human Trials: Understanding the Regulatory Process - Tatiana M. Prowell and Chris H. Takimoto
: Written and Oral Research Presentations That Audiences Remember - Roy S. Herbst, Mary Jackson Scroggins, and Eric P. Winer

Small Groups Discussion Sessions 3-4 (9:15 am-10:15 am)
: Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints - Emily V. Dressler, Jane Perlmutter, and Walter M. Stadler
: Waterfalls, Swimmers, and Who Are Kaplan and Meier Anyway - Michael A. Carducci and Sean M. Devlin

Break / Group Photo (10:20 am-10:40 am)

Small Group Discussion Sessions 5-7 (10:40 am-11:40 am)
: Imaging Endpoints - Richard J. Chappell and Thomas E. Yankeelov
: Laboratory Correlates - A. Craig Lockhart, Wendy B. London, and Kurt A. Schalper
: Challenges of Umbaskets - Edward Chu, Jane Perlmutter, and Mary W. Redman

Lunch (11:40 am-12:40 pm)

Lecture Session 5 (12:40 pm-1:55 pm)
: Navigating the National Clinical Trials Network - John C. Byrd
: Patient-Reported Outcomes - Smita Bhatia
: Barriers to Accrual and How to Overcome Them - Carole L. Baas and Stuart M. Lichtman

Protocol Development Group Session 4 (2:00 pm-4:00 pm)

Independent Study Time/Dinner on Own (4:00 pm-8:30 pm)

Optional Career Sessions (4:15 pm-5:00 pm)
: Careers in Government - Richard F. Little and Tatiana M. Prowell
: Careers in Industry - Stuart G. Lutzker, Neal J. Meropol, Chris H. Takimoto
: Careers in Radiation Oncology - Jeffrey A. Bogart, Adam P. Dicker, and Karyn A. Goodman
: Engaging the Advocates - Carole L. Baas, Deborah E. Collyar, Ivy B. Elkins, Josh Mailman, Pamela R. Moffitt, Jane Perlmutter, Laurel Pracht, and Mary Jackson Scroggins

ASSIGNMENT DUE: PROTOCOL DRAFTS (8:30 pm)


WEDNESDAY, AUGUST 1, 2018

Breakfast (7:00 am-8:00 am)

Lecture Session 6 (8:00 am-10:00 am)
: You’re In Charge: Investigator Responsibilities - Alex A. Adjei
: Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study - Ivy B. Elkins, Neal J. Meropol, Pamela R. Moffitt, and Jyoti D. Patel
: Challenges of Multi-Institutional Trials: How Do We Pay For It - Walter M. Stadler
: Data Collection: It’s All In the Data (when to look at data, how to collect data, real-world data collection situations, how to prevent wrong data) - Mark Krailo

Break (10:00 am-10:15 am)

Lecture Session 7 (10:15 am-11:15 am)
: Special Populations in Clinical Trials - Rochelle Bagatell, Stuart M. Lichtman, and Josh Mailman

Protocol Development Group Session 5 (11:15 am-12:45 pm)

Lunch (12:45 pm-1:30 pm)

Office Hours 3 (1:30 pm-3:30 pm)

Independent Study Time/Dinner on own (3:30 pm-8:00 pm)

Optional Networking Session: Women in Academia (4:30 pm-5:30 pm)

ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS (8:00 pm)


THURSDAY, AUGUST 2, 2018

Breakfast (7:00 am-8:00 am)

Special Interest Sessions (8:00 am-9:00 am)
: Taking Your Product to Clinic - Stuart G. Lutzker and Chris H. Takimoto
: Palliative Care and Quality of Life - Stuart M. Lichtman and Laurel Pracht

Lecture Session 8 (9:05 am-10:30 am)
: Successful Grantsmanship - Mary L. Disis
: Your Clinician-Scientist Pail List - Daniel D. Von Hoff

Protocol Development Group Session 6 (10:30 am-12:00 pm)

Administration of Post-test (12:10 pm-1:10 pm)

Independent Study Time / Lunch (1:10 pm-7:00 pm)

ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS (7:00 pm)

Closing Reception / Banquet / Dance (7:00 pm-11:00 pm)


FRIDAY, AUGUST 3, 2018

Continental Breakfast (5:00 am-8:00 am)

Departure (6:00 am-8:30 am / 7:15 am-9:45 am / 10:00 am-12:30 pm)

Comments from 2017 Workshop Participants:


"Amazing experience - the most educational and inspiring experience of my residency. Inspiring and brilliant community. Wonderful, kind PDG leaders that guided us throughout the process and helped optimize our study design. The gold standard course for learning about clinical trial design."

"This was the best training experience I ever had. Fantastic mentors and colleagues. I didn't think it was possible to learn so much in less than a week! Thank you all so much!!"

"This was a wonderful opportunity. I never imagine I could get this much done in a week - write a full protocol, get feedback to improve my design and write it again, meet this many people and enjoy the scenery and zip lining at Vail! What I learned here will stay with me for life."

"The conference was spectacular!! I learned a tremendous amount about clinical trial design, and I'm confident that I now have the foundation needed to move forward in my career."

"This is THE best workshop or conference among all that I have ever attended throughout my entire career. Faculties were truly motivating and open to any questions or feedback. Having an opportunity to talk to mentors and other faculties during the office hour or small group sessions changed my view of career development."

"This was one of the best experiences of my entire residency training and I would recommend this course to any young faculty member or trainee."