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Program-2017

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 29 (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 3, after the last Workshop assignment is due. Departure is on Friday morning, August 4.


SATURDAY, JULY 29, 2017

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 30, 2017

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

Lecture Session 1 (8:00 am-10:40 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
: Phase 2 Trial Questions/Objectives - George W. Sledge, Jr.
: Phase 2 Trial Designs - Elizabeth S. Garrett-Mayer

Break (10:40 am-11:00 am)

Lecture Session 2 (11:00 am-12:30 pm)
: Practical Aspects of Asking Good Questions - Michael A. Carducci
: 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 (12:30 pm-3:45 pm)

Independent Study Time (3:45 pm-7:30 pm)

Office Hours 1 (Biostatisticians Only) (3:45 pm-6:30 pm)

ASSIGNMENT DUE: PROTOCOL SYNOPSIS SHEETS [Background, Objectives, Endpoints, etc.] (7:30 pm)

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


MONDAY, JULY 31, 2017

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

Lecture Session 3 (8:00 am-10:00 am)
: Feasibility and Reproducibility in Biomarker Studies - Kurt A. Schalper
: Incorporation of Biological Correlative Studies into Early Clinical Trials - Patricia M. LoRusso
: Statistical Aspects of Correlative Studies - Wendy B. London
: Panel Discussion / Q&A - Wendy B. London, Patricia M. LoRusso, Kurt A. Schalper, and Kay F. Kays

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

Lecture Session 4 (10:15 am-11:45 am)
: Imaging in the Era of Targeted Therapy and Immunotherapy - Terence Z. Wong
: 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, Terence Z. Wong, and Katherine Panageas

Protocol Development Group Session 3 / Lunch (11:45 am-3:00 pm)

Office Hours 2: Protocol Related Questions (3:15 pm-5:15 pm)

Independent Study Time / Dinner (5:15 pm-8:30 pm)

ASSIGNMENT DUE: STATISTICAL SECTION (8:30 pm)


TUESDAY, AUGUST 1, 2017

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 and George W. Sledge, Jr.

Small Groups Discussion Sessions 3-4 (9:15 am-10:15 am)
: Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints - Motomi Mori and Walter M. Stadler
: Visual Display of Data - 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 - Terence Z. Wong
: Laboratory Correlates - S. Percy Ivy, Wendy B. London, and Kurt A. Schalper
: Molecular Medicine / Selection Eligibility - Edward Chu 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 - Neal J. Meropol
: Patient-Reported Outcomes - Christopher R. Flowers
: Barriers to Accrual and How to Overcome Them - Carole L. Baas and Neal J. Meropol

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 - S. Percy Ivy and Tatiana M. Prowell
: Careers in Industry - Michael T. Lotze, Stuart G. Lutzker, and Chris H. Takimoto
: Careers in Radiation Oncology - Karyn A. Goodman and Christopher G. Willett
: Working with Patient Advocates - Carole L. Baas, Everett E. Dodson, Kay F. Kays, Pamela R. Moffitt, Laurel Pracht, and Virgil H. Simons

ASSIGNMENT DUE: PROTOCOL DRAFTS (8:30 pm)


WEDNESDAY, AUGUST 2, 2017

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

Lecture Session 6 (8:00 am-10:00 am)
: Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study - Jyoti D. Patel, George W. Sledge, Jr., Kay F. Kays, and Pamela R. Moffitt
: You’re In Charge: Investigator Responsibilities - Alex A. Adjei
: Data Collection: It’s All In the Data - Katherine Panageas

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

Lecture Session 7 (10:15 am-11:15 am)
: Special Populations in Clinical Trials - Everett E. Dodson, Stuart M. Lichtman, and Franklin O. Smith, III

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 3, 2017

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
: Considerations in Design of Trials with Longer Survival: Pediatric and Survivorship Perspective - Rochelle Bagatell, Ralph D’Agostino, and Virgil H. Simons
: Multi-institutional Trials - Tracy T. Batchelor and Gina R. Petroni

Lecture Session 8 (9:05 am-11:05 am)
: Career Development Opportunities: The Government Can Help - Jonathan S. Wiest
: Successful Grantsmanship - Mary L. Disis
: Special Lecture from Workshop Founder: Deep Learning - Daniel D. Von Hoff

Protocol Development Group Session 6 (11:05 am-12:30 pm)

Administration of Post-test (12:40 pm-1:30 pm)

Independent Study Time / Lunch (1:30 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 4, 2017

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."