2012 AACR/ASCO Workshop: Methods in Clinical Cancer Research

2012 AACR/ASCO Workshop

Methods in ClinicalCancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, Colorado

2011 Workshop Attendees

Program CommitteeCourse Directors: Lee M. Ellis, M.D.Mary L. (Nora) Disis, M.D.Mithat Gönen, Ph.D.

NEW IN 2012: For those protocols using agents from apharmaceutical company that are not FDA approved for thedisease under study, the final application will require a letter ofcommitment from the collaborating company stating that drug willbe supplied for the proposed trial. Priority will be given toapplicants that have a letter that is uploaded with the application(preferably a letter of commitment, but at minimum, we request aletter of intent). If a letter is not included, the application is unlikelyto be approved.

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An Intensive Workshop in the Essentials of EffectiveClinical Trial Design of Therapeutic Interventions inthe Treatment of Cancer for Clinical Fellow andJunior Faculty Clinical Researchers in All OncologySubspecialties, including Radiation and SurgicalOncology and Radiology

Al l accepted applicants receive financial assistance to attend.

Supported by a generous grant from the National Cancer Institute and educational grants from corporate supporters

Application Deadline: Friday, March 16


Methods in Clinical Cancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, Colorado

Faculty Members Faculty subject to change, additional faculty to be announced.

Stacey L. Berg, M.D.Texas Children's Cancer Center/Dan L. Duncan Cancer CenterBaylor College of MedicineHouston, TX

Michael R. Bishop, M.D.Medical College of WisconsinMilwaukee, WI

A. William Blackstock, M.D.Wake Forest University School of MedicineWinston Salem, NC

Richard J. Chappell, Ph.D.University of WisconsinMadison, WI

Laura G. ClevelandPowell, OH

Mary L. (Nora) Disis, M.D.University of WashingtonSeattle, WA

Chaitanya R. Divgi, M.D.Columbia University Medical CenterNew York, NY

S. Gail Eckhardt, M.D.University of Colorado Cancer CenterAurora, CO

Lee M. Ellis, M.D.University of Texas MD Anderson Cancer CenterHouston, TX

Lawrence H. Fong, M.D.University of CaliforniaSan Francisco, CA

Margaret Foti, Ph.D., M.D. (h.c.) American Association for Cancer ResearchPhiladelphia, PA

Elizabeth S. Garrett-Mayer, Ph.D.Medical University of South CarolinaHollings Cancer CenterCharleston, SC

Mithat Gönen, Ph.D.Memorial Sloan-Kettering Cancer CenterNew York, NY

Ana Maria Gonzalez-Angulo, M.D., M.Sc.University of Texas MD Anderson Cancer CenterHouston, TX

Stuart A. Grossman, M.D.Johns Hopkins University School of Medicine Sidney Kimmel Comprehensive Cancer CenterBaltimore, MD

Sandra J. Horning, M.D.Genentech, Inc.South San Francisco, CA

Judith E. Karp, M.D.Johns Hopkins University Sidney KimmelComprehensive Cancer CenterBaltimore, MD

Mark D. Krailo, Ph.D.Children’s Oncology Group/USC Keck School of MedicineArcadia, CA

Daniel A. Laheru, M.D.Johns Hopkins University School of MedicineBaltimore, MD

Barbara K. LeStage, M.P.H.Wrentham, MA

Wendy B. London, Ph.D.Dana-Farber Cancer Institute/Children’s Hospital BostonBoston, MA

Patricia M. LoRusso, D.O.Barbara Ann Karmanos Cancer CenterDetroit, MI

Vicki A. Morrison, M.D.University of MinnesotaVA Medical CenterMinneapolis, MN

Katherine Panageas, Dr.P.H.Memorial Sloan-Kettering Cancer CenterNew York, NY

Edith A. Perez, M.D.Mayo Clinic Jacksonville, FL

Alfred W. Rademaker, Ph.D.Northwestern UniversityChicago, IL

Meredith M. Regan, Sc.D.Dana-Farber Cancer InstituteBoston, MA

Brian I. Rini, M.D., F.A.C.P.Cleveland Clinic Lerner College of Medicine/Case Western Reserve UniversityCleveland, OH

Karl L. Schwartz, M.F.A.Patients Against LymphomaRiegelsville, PA

Mary Jackson Scroggins, M.A.In My Sister’s CareWashington, DC

Westley Sholes, M.S.California Prostate Cancer CoalitionRancho Palos Verdes, CA

Yu Shyr, Ph.D.Vanderbilt-Ingram Cancer CenterNashville, TN

George W. Sledge, Jr., M.D.Indiana University Simon Cancer CenterIndianapolis, IN

Franklin O. Smith, III, M.D.University of Cincinnati Cancer InstituteCincinnati, OH

Anil K. Sood, M.D.University of Texas MD Anderson Cancer CenterHouston, TX

Steven P. Stratton, Ph.D.University of Arizona Cancer CenterTucson, AZ

Lisa L. Taylor, M.B.A.Packers Falls Group, Inc.Durham, NH

Charles Richard Thomas, Jr., M.D.Oregon Health & Science University Knight Cancer InstitutePortland, OR

Jamie H. Von Roenn, M.D.Northwestern University School of MedicineChicago, IL

Nu Viet Vu, Ph.D.University of Geneva, Medical SchoolGeneva, Switzerland

Vivian Weinberg, Ph.D.UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, CA

Heidi L. Weiss, Ph.D.University of KentuckyMarkey Cancer CenterLexington, KY

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Goals of the Workshop

Errors made in the design and conduct of a clinical trialcan make it impossible for the trial to provide a definitiveanswer about the effectiveness of a new approach. Poordesign can lead to the abandonment of promisingavenues of research that are based on sound basicscientific work as well as to delays in the introduction ofnew treatments into the practice of oncology. AACR andASCO have designed this intensive workshop to increasethe reliability and effectiveness of clinical trials by:

• Introducing clinical fellows and junior faculty in any oncologysubspecialty to the principles of good clinical trial design.This workshop will give them the tools they need to conductclinical trials that will yield clear results that investigators canuse to proceed to the next level of research.

• Exposing early career clinical scientists to the full spectrum ofchallenges in clinical research – from surgery, radiotherapy,conventional and investigational antineoplastic agents andmultidisciplinary treatment regimens to gene therapy,biologic therapy, and multimodality and combinationtreatments. Workshop faculty seek to inspire participants todevote all or a portion of their future careers to some aspectof clinical research.

• Developing a cadre of well-trained, experienced clinicalresearchers whose expertise will foster better clinical trialdesign. Such expertise will thereby hasten the introduction ofimproved regimens for cancer therapy and prevention intoeveryday medical practice and patient care.

General Information

Selection of Participants

The faculty will review and accept applications from clinicalfellows and junior faculty as described below. The faculty willbase their decisions in large part on the quality of theproposed protocol and on the submissions by the applicantand the sponsor (Program Supervisor or Department Head ormentor). These documents will be scrutinized both for theinformation they supply about the candidate and theassurances they provide about the participation of thecandidate and sponsor in the long-term evaluation of the

workshop. The workshop organizers have set a priority onincreasing the participation of students of African Americanand Hispanic/Latino descent and individuals from thosegroups are strongly encouraged to submit applications. Note that selection of workshop applicants is conducted on a competitive basis with fewer than half of the applicants accepted each year due to limited space.Unsuccessful applicants are encouraged to reapply thefollowing year. Applicants will be notified of their status by the beginning of May.

Fellows Receive Full Scholarships

The organizers will award scholarships to 75 applicantswho are clinical fellows in any oncology subspecialty orradiology. The faculty will seek a group of trainees whohave made outstanding progress in their medical training,who have displayed an interest and competence in clinicalcancer research, and who come from a diverse group oftraining institutions and personal backgrounds.

The 75 participants selected from this group will not berequired to pay any registration fee for the workshop.They will also receive complimentary airline tickets (with acap on international travel), hotel accommodations in Vailfor the nights of July 28 through August 2 inclusive, andcomplimentary meals throughout the workshop, with theexception of dinner on Monday, Tuesday, and Wednesday.Participants who receive scholarships will be required toshare sleeping rooms with another participant. Allparticipants must pay an activity fee of $100 to offset thecosts of social events and a group photo.

Junior Faculty Receive a Stipend

The organizers will also admit to the course 25 clinicalscientists in training who have already embarked onacademic careers; who hold an appointment at the level ofAssistant Professor, Instructor, or Lecturer; and whocompleted their fellowships after April 30, 2007. Thesescientists will not be required to pay a registration fee for theworkshop, although they will be required to pay a $100activity fee. Junior faculty will also receive complimentarymeals throughout the workshop (with the exception of dinneron Monday, Tuesday, and Wednesday) and a stipend of$599 (nontaxable) to support their travel and housing costs.

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Workshop Materials

Faculty members will contribute material to the electronicworkshop syllabus that will be available electronically to allparticipants. For every lecture and small group discussionsession, the syllabus will contain the instructional objectivesfor the presentation, an outline of the topics to be covered,and a research bibliography of relevant articles and texts.

Workshop Site

Workshop sessions will take place at the Vail MarriottMountain Resort, Vail, Colorado. While particularly famousfor its outstanding winter skiing, Vail offers a fullcomplement of summer recreational activities – includinghiking, golfing, fishing, mountain climbing, horsebackriding, and swimming – just a short distance from the resort.

Transportation from the Airport

Arrangements will be made for complimentary shuttle bustransport (a 2½ hour ride) for workshop participantsbetween the Denver International Airport and the VailMarriott Mountain Resort on Saturday mid-day, July 28and again on Friday morning, August 3. Those admitted tothe workshop will receive the schedule for these specialbuses, which are the only buses on which complimentarytransportation will be provided.

Workshop Housing – Sharing Accommodations

All applicants accepted to the workshop must reside at theVail Marriott Mountain Resort for the duration of theworkshop and participate in all group meals. Fellows willreceive the following complimentary accommodations atthe resort: a hotel room to be shared with one otherworkshop participant for the nights of Saturday, July 28,through Thursday, August 2, inclusive. Fellows requestingother accommodations at the Vail Marriott Mountain Resortwill be reimbursed only for the amount that AACR andASCO would have been charged for the complimentaryaccommodations offered as part of the package(approximately $105 per night).

The following accommodations are available to juniorfaculty: Lodge Room at $226 per night. This price, perroom per night, is based on single or double occupancyand includes local and state taxes. Junior faculty will havethe option of sharing hotel rooms with other participants.

Scientific Session Formats

The scientific program for the workshop consists of fiveeducational formats to serve a variety of didactic needs:

• Protocol development group sessions during which eachparticipant develops a concept sheet for a clinical trialprotocol and, through extensive mentoring, designs andcompletes the writing of the protocol before the end ofthe workshop. These sessions constitute the core activityof the workshop and allow students to apply the lessonsbeing learned in the workshop to their own programsand receive detailed critiques of their protocols fromexperienced scientists.

• Lectures on specific topics presented by experts in thefield. These talks give participants an essential overviewof the field and of the principles of design and conductof high-quality clinical trials. Some lectures are followedpanel discussions or case studies so students and facultycan explore issues in greater depth.

• Small group discussion sessions on special topics such aslaboratory correlates, imaging endpoints in clinical trials,and measuring immunologic outcomes. These sessionstreat topics that are either essential to the success ofmany different kinds of clinical trials or offer anopportunity for in-depth discussion on topics of specialinterest to clinical investigators. Attendance at eachsession will be limited to maximize dialogue and tofacilitate the educational experience.

•Office hours provide time for individual counseling andadvice on protocol and career development.

• Special interest group and career sessions provide anetworking, mentoring, and career-advice forum forindividuals with topics such as surgical oncology,pediatric oncology, radiation oncology, and becoming aPhase I investigator.



General Information


Participants should plan to arrive at the Vail MarriottMountain Resort no later than 3:00 p.m. on Saturday, July 28. The workshop will begin with a mandatory pretestat 4:00 p.m. A closing reception and banquet will be heldon Thursday evening, August 2, after the last workshopassignment is due. The workshop will adjourn afterbreakfast on Friday, August 3. Session topics andschedule are subject to change, please visitwww.vailworkshop.org for updates.

Saturday, July 28, 2012• Registration

• Administration of Pretest

• Protocol Development Group Session I

• Dinner

Sunday, July 29, 2012• Continental Breakfast

• Lecture Session 1

• Buffet Lunch

• Protocol Development Group Session 2

• Office Hours 1: Protocol Related Questions

• Independent Study Time

• ASSIGNMENT DUE

• Reception

• Buffet Dinner

Monday, July 30, 2012• Continental Breakfast



• Buffet Lunch


• Small Group Discussion Sessions 1-2


• Independent Study Time/Dinner on Own

• ASSIGNMENT DUE

Tuesday, July 31, 2012• Continental Breakfast


• Break/Group Photo


• Buffet Lunch


• Office Hours 2: Protocol Related Questions


• ASSIGNMENT DUE


Tentative Daily Program



Tentative Daily Program


Wednesday, August 1, 2012• Continental Breakfast



• Boxed Lunch


• Special Interest Group and Career Sessions

• Office Hours 3: Any Question Topics (protocol, career, etc.)


• ASSIGNMENT DUE

Thursday, August 2, 2012• Continental Breakfast



• Lunch/Buffet

• Administration of Posttest

• Independent Study Time

• ASSIGNMENT DUE

• Reception/Banquet/Dance

Friday, August 3, 2012• Continental Breakfast

• Adjournment and Departure

Some comments from past Workshopparticipants . . .

“With regard to the workshop, all I can sayis that it was a terrific experience – intense,informative, and extremely helpful in termsof shaping my career as a clinicalresearcher.”

“Without any doubt, it was perhaps the bestconference that I have ever attended . . . Iespecially liked the fact that one arrives withan idea and during the course of the weekthere is an opportunity to implement thatidea into a solid protocol.”

“The Methods in Clinical Cancer ResearchWorkshop was an extremely valuablelearning experience. The lectures covered a broad range of noteworthy topics in the design and conduct of clinical trials, and the presentations were of thehighest caliber.”

“The protocol development group leadersclearly took their responsibilities seriously,providing detailed and thoughtful commentson my protocol, and useful advice for thedevelopment of clinical trials in general.”


Online Application Procedure

We are pleased to offer a completely online procedure toapply to participate in the AACR/ASCO Workshop onMethods in Clinical Cancer Research. Simply visit theworkshop website, www.vailworkshop.org, and follow theonscreen instructions. Only online applications will be considered; papersubmissions will not be accepted.

In summary, the online application procedure requires thefollowing items from applicants:• A completed online Application Form. • A one to two-page description of the clinical trial

protocol you intend to write during the workshop and itsfeasibility (protocols that are largely written before theworkshop are not acceptable).

• Your personal C.V. (electronic version). • A statement explaining why you wish to participate in this

Workshop. • A statement from your Program Supervisor or

Department Head or mentor in support of yourapplication for this workshop.

Detailed instructions for each of these items can be foundon the online Application Form. Applications will not beaccepted unless they contain all FIVE elements describedabove. The deadline for receipt of online applications isFriday, March 16.For questions about the application process, contactNatalie Konrad, AACR Staff Assistant at (215) 446-7177 [email protected].

Workshop Preparation

Those accepted for the workshop should come preparedto develop the clinical research concept submitted withtheir application into a complete clinical trial protocolduring the course of the workshop. They should bringtheir institution’s protocol and informed consenttemplates. A background literature review is required aspreparation for the workshop. They should come with adraft of the background section of their protocol.Participants must bring a laptop computer to theworkshop to facilitate their completion of the dailyassignments.

For those protocols using agents from apharmaceutical company that are not FDA approvedfor the disease under study, the final application willrequire a letter of commitment from the collaboratingcompany stating that drug will be supplied for theproposed trial. Priority will be given to applicants thathave a letter that is uploaded with the application(preferably a letter of commitment, but at minimum,we request a letter of intent). If a letter is notincluded, the application is unlikely to be approved.

Benefits of Attendance:

The organizers conduct thorough short- and long-termevaluations of the workshop to assure that it meets itsobjectives and provides the attendees with the skills theyneed to be effective clinical investigators. Some of thehighlights from past evaluations demonstrate the manybenefits of attendance:

• Participants of the last 10 workshops have recognizedthat the workshop is a “must attend” event for theadvancement of their careers and research training –100% of them indicated they would recommend thiscourse to someone whose training was similar to theirs.

• More than two-thirds of the students who attended the2011 workshop were referred to the workshop basedupon the recommendation of a colleague.

• Participants have rated highly the daily small protocoldevelopment group sessions that constitute the core ofthe workshop. Participants indicated that they receivedconstructive feedback from the faculty in their protocoldevelopment group sessions and 96% of the participantsdeparted the workshop with a completed protocol inhand, ready to submit to their IRB for approval.

• Fully 99% of the attendees indicated that theorganization of the course and scheduling of activitieswere excellent and that they had many opportunities tointeract and network with the faculty.

• Long-term evaluations of the workshop demonstrate thecontinuing productivity of the graduates. Three yearsafter the workshop, two-thirds or more of the attendeesspend substantial time in patient-oriented ortranslational research and have designed and/orparticipated in designing three or more protocols whichwere approved by an IRB and implemented.

615 Chestnut Street, 17th Floor • Philadelphia, PA 19106-4404 • 215-440-9300 • Fax: 215-599-0111 • E-mail: [email protected]

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• Learn from the experts how to design an

effective clinical trial of a therapeutic

intervention in the treatment of cancer in

any oncologic research subfield

• Apply basic therapeutic clinical trial

design concepts to any clinical research

specialty, including radiation and surgical

oncology and radiology

• Avoid costly and embarrassing mistakes

in clinical trial design and implementation

• Understand advanced clinical trial design

principles involving multimodality trials

• Enhance the validity and reliability of

clinical trials

• Individuals of African American and

Hispanic/Latino descent are especially

encouraged to apply

• Compete to receive either a full

scholarship or a stipend to attend,

depending upon academic status



Full Program Details

and Application

Procedures Inside

Convenient Online

Application Process

Designed for

Individuals in Any

Clinical Research

Specialty Area

and Radiology

Scholarship Assistance

for All Successful Applicants

Application Deadline: March 16, 2012

Documents

2012 AACR/ASCO Workshop: Methods in Clinical Cancer Research