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2012 AACR/ASCO Workshop: Methods in Clinical Cancer Research

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  • 1. 2012 AACR/ASCO WorkshopMethods in ClinicalCancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, Colorado 2011 Workshop AttendeesAn Intensive Workshop in the Essentials of Effective Program CommitteeClinical Trial Design of Therapeutic Interventions in Course Directors:the Treatment of Cancer for Clinical Fellow and Lee M. Ellis, M.D.Junior Faculty Clinical Researchers in All Oncology Mary L. (Nora) Disis, M.D.Subspecialties, including Radiation and Surgical Mithat Gönen, Ph.D.Oncology and RadiologyAl l accepted applicant s recei ve financial NEW IN 2012: For those protocols using agents from aassi st ance to attend. pharmaceutical company that are not FDA approved for the disease under study, the final application will require a letter ofSupported by a generous grant from the commitment from the collaborating company stating that drug will be supplied for the proposed trial. Priority will be given toNational Cancer Institute applicants that have a letter that is uploaded with the applicationand educational grants from corporate supporters (preferably a letter of commitment, but at minimum, we request a letter of intent). If a letter is not included, the application is unlikely to be approved.Application Deadline:Friday, March 16 W W W . V A I L W O R K S H O P. O R G
  • 2. 2012 AACR/ASCO WorkshopMethods in Clinical Cancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, ColoradoFaculty Members Faculty subject to change, additional faculty to be announced.Stacey L. Berg, M.D. Sandra J. Horning, M.D. Mary Jackson Scroggins, M.A.Texas Childrens Cancer Center/ Genentech, Inc. In My Sister’s CareDan L. Duncan Cancer Center South San Francisco, CA Washington, DCBaylor College of Medicine Judith E. Karp, M.D. Westley Sholes, M.S.Houston, TX Johns Hopkins University Sidney Kimmel California Prostate Cancer CoalitionMichael R. Bishop, M.D. Comprehensive Cancer Center Rancho Palos Verdes, CAMedical College of Wisconsin Baltimore, MD Yu Shyr, Ph.D.Milwaukee, WI Mark D. Krailo, Ph.D. Vanderbilt-Ingram Cancer CenterA. William Blackstock, M.D. Children’s Oncology Group/USC Keck Nashville, TNWake Forest University School of Medicine School of Medicine George W. Sledge, Jr., M.D.Winston Salem, NC Arcadia, CA Indiana University Simon Cancer CenterRichard J. Chappell, Ph.D. Daniel A. Laheru, M.D. Indianapolis, INUniversity of Wisconsin Johns Hopkins University School of Medicine Franklin O. Smith, III, M.D.Madison, WI Baltimore, MD University of Cincinnati Cancer InstituteLaura G. Cleveland Barbara K. LeStage, M.P.H. Cincinnati, OHPowell, OH Wrentham, MA Anil K. Sood, M.D.Mary L. (Nora) Disis, M.D. Wendy B. London, Ph.D. University of Texas MD Anderson Cancer CenterUniversity of Washington Dana-Farber Cancer Institute/ Houston, TXSeattle, WA Children’s Hospital Boston Steven P Stratton, Ph.D. . Boston, MAChaitanya R. Divgi, M.D. University of Arizona Cancer CenterColumbia University Medical Center Patricia M. LoRusso, D.O. Tucson, AZNew York, NY Barbara Ann Karmanos Cancer Center Lisa L. Taylor, M.B.A. Detroit, MIS. Gail Eckhardt, M.D. Packers Falls Group, Inc.University of Colorado Cancer Center Vicki A. Morrison, M.D. Durham, NHAurora, CO University of Minnesota Charles Richard Thomas, Jr., M.D. VA Medical CenterLee M. Ellis, M.D. Oregon Health & Science University Minneapolis, MNUniversity of Texas MD Anderson Cancer Center Knight Cancer InstituteHouston, TX Katherine Panageas, Dr.P .H. Portland, OR Memorial Sloan-Kettering Cancer CenterLawrence H. Fong, M.D. Jamie H. Von Roenn, M.D. New York, NYUniversity of California Northwestern University School of MedicineSan Francisco, CA Edith A. Perez, M.D. Chicago, IL Mayo ClinicMargaret Foti, Ph.D., M.D. (h.c.) Nu Viet Vu, Ph.D. Jacksonville, FLAmerican Association for Cancer Research University of Geneva, Medical SchoolPhiladelphia, PA Alfred W. Rademaker, Ph.D. Geneva, Switzerland Northwestern UniversityElizabeth S. Garrett-Mayer, Ph.D. Vivian Weinberg, Ph.D. Chicago, ILMedical University of South Carolina UCSF Helen Diller FamilyHollings Cancer Center Meredith M. Regan, Sc.D. Comprehensive Cancer CenterCharleston, SC Dana-Farber Cancer Institute San Francisco, CA Boston, MAMithat Gönen, Ph.D. Heidi L. Weiss, Ph.D.Memorial Sloan-Kettering Cancer Center Brian I. Rini, M.D., F.A.C.P. University of KentuckyNew York, NY Cleveland Clinic Lerner College of Medicine/ Markey Cancer Center Case Western Reserve University Lexington, KYAna Maria Gonzalez-Angulo, M.D., M.Sc. Cleveland, OHUniversity of Texas MD Anderson Cancer CenterHouston, TX Karl L. Schwartz, M.F.A. Patients Against LymphomaStuart A. Grossman, M.D. Riegelsville, PAJohns Hopkins University School of MedicineSidney Kimmel Comprehensive Cancer CenterBaltimore, MD2 W W W . V A I L W O R K S H O P . O R G
  • 3. Goals of the Workshop workshop. The workshop organizers have set a priority on increasing the participation of students of African American and Hispanic/Latino descent and individuals from thoseErrors made in the design and conduct of a clinical trial groups are strongly encouraged to submit applications.can make it impossible for the trial to provide a definitive Note that selection of workshop applicants is conductedanswer about the effectiveness of a new approach. Poor on a competitive basis with fewer than half of thedesign can lead to the abandonment of promising applicants accepted each year due to limited space.avenues of research that are based on sound basic Unsuccessful applicants are encouraged to reapply thescientific work as well as to delays in the introduction of following year. Applicants will be notified of their statusnew treatments into the practice of oncology. AACR and by the beginning of May.ASCO have designed this intensive workshop to increasethe reliability and effectiveness of clinical trials by:• Introducing clinical fellows and junior faculty in any oncology Fellows Receive Full Scholarships subspecialty to the principles of good clinical trial design. The organizers will award scholarships to 75 applicants This workshop will give them the tools they need to conduct who are clinical fellows in any oncology subspecialty or clinical trials that will yield clear results that investigators can radiology. The faculty will seek a group of trainees who use to proceed to the next level of research. have made outstanding progress in their medical training,• Exposing early career clinical scientists to the full spectrum of who have displayed an interest and competence in clinical challenges in clinical research – from surgery, radiotherapy, cancer research, and who come from a diverse group of conventional and investigational antineoplastic agents and training institutions and personal backgrounds. multidisciplinary treatment regimens to gene therapy, The 75 participants selected from this group will not be biologic therapy, and multimodality and combination required to pay any registration fee for the workshop. treatments. Workshop faculty seek to inspire participants to They will also receive complimentary airline tickets (with a devote all or a portion of their future careers to some aspect cap on international travel), hotel accommodations in Vail of clinical research. for the nights of July 28 through August 2 inclusive, and• Developing a cadre of well-trained, experienced clinical complimentary meals throughout the workshop, with the researchers whose expertise will foster better clinical trial exception of dinner on Monday, Tuesday, and Wednesday. design. Such expertise will thereby hasten the introduction of Participants who receive scholarships will be required to improved regimens for cancer therapy and prevention into share sleeping rooms with another participant. All everyday medical practice and patient care. participants must pay an activity fee of $100 to offset the costs of social events and a group photo. Junior Faculty Receive a StipendGeneral Information The organizers will also admit to the course 25 clinical scientists in training who have already embarked onSelection of Participants academic careers; who hold an appointment at the level of Assistant Professor, Instructor, or Lecturer; and whoThe faculty will review and accept applications from clinical completed their fellowships after April 30, 2007. Thesefellows and junior faculty as described below. The faculty will scientists will not be required to pay a registration fee for thebase their decisions in large part on the quality of the workshop, although they will be required to pay a $100proposed protocol and on the submissions by the applicant activity fee. Junior faculty will also receive complimentaryand the sponsor (Program Supervisor or Department Head or meals throughout the workshop (with the exception of dinnermentor). These documents will be scrutinized both for the on Monday, Tuesday, and Wednesday) and a stipend ofinformation they supply about the candidate and the $599 (nontaxable) to support their travel and housing costs.assurances they provide about the participation of thecandidate and sponsor in the long-term evaluation of theW W W . V A I L W O R K S H O P . O R G 3
  • 4. 2012 AACR/ASCO WorkshopMethods in Clinical Cancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, ColoradoGeneral InformationWorkshop Materials The following accommodations are available to junior faculty: Lodge Room at $226 per night. This price, perFaculty members will contribute material to the electronic room per night, is based on single or double occupancyworkshop syllabus that will be available electronically to all and includes local and state taxes. Junior faculty will haveparticipants. For every lecture and small group discussion the option of sharing hotel rooms with other participants.session, 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. Scientific Session Formats The scientific program for the workshop consists of fiveWorkshop Site educational formats to serve a variety of didactic needs:Workshop sessions will take place at the Vail Marriott • Protocol development group sessions during which eachMountain Resort, Vail, Colorado. While particularly famous participant develops a concept sheet for a clinical trialfor its outstanding winter skiing, Vail offers a full protocol and, through extensive mentoring, designs andcomplement of summer recreational activities – including completes the writing of the protocol before the end ofhiking, golfing, fishing, mountain climbing, horseback the workshop. These sessions constitute the core activityriding, and swimming – just a short distance from the resort. of the workshop and allow students to apply the lessons being learned in the workshop to their own programs and receive detailed critiques of their protocols from experienced scientists.Transportation from the Airport • Lectures on specific topics presented by experts in theArrangements will be made for complimentary shuttle bus field. These talks give participants an essential overviewtransport (a 2½ hour ride) for workshop participants of the field and of the principles of design and conductbetween the Denver International Airport and the Vail of high-quality clinical trials. Some lectures are followedMarriott Mountain Resort on Saturday mid-day, July 28 panel discussions or case studies so students and facultyand again on Friday morning, August 3. Those admitted to can explore issues in greater depth.the workshop will receive the schedule for these specialbuses, which are the only buses on which complimentary • Small group discussion sessions on special topics such astransportation will be provided. laboratory correlates, imaging endpoints in clinical trials, and measuring immunologic outcomes. These sessions treat topics that are either essential to the success ofWorkshop Housing – Sharing Accommodations many different kinds of clinical trials or offer an opportunity for in-depth discussion on topics of specialAll applicants accepted to the workshop must reside at the interest to clinical investigators. Attendance at eachVail Marriott Mountain Resort for the duration of the session will be limited to maximize dialogue and toworkshop and participate in all group meals. Fellows will facilitate the educational experience.receive the following complimentary accommodations atthe resort: a hotel room to be shared with one other •Office hours provide time for individual counseling andworkshop participant for the nights of Saturday, July 28, advice on protocol and career development.through Thursday, August 2, inclusive. Fellows requesting • Special interest group and career sessions provide aother accommodations at the Vail Marriott Mountain Resort networking, mentoring, and career-advice forum forwill be reimbursed only for the amount that AACR and individuals with topics such as surgical oncology,ASCO would have been charged for the complimentary pediatric oncology, radiation oncology, and becoming aaccommodations offered as part of the package Phase I investigator.(approximately $105 per night).4 W W W . V A I L W O R K S H O P . O R G
  • 5. Tentative Daily ProgramParticipants should plan to arrive at the Vail Marriott Monday, July 30, 2012Mountain Resort no later than 3:00 p.m. on Saturday, • Continental BreakfastJuly 28. The workshop will begin with a mandatory pretestat 4:00 p.m. A closing reception and banquet will be held • Lecture Session 2on Thursday evening, August 2, after the last workshop • Lecture Session 3assignment is due. The workshop will adjourn after • Buffet Lunchbreakfast on Friday, August 3. Session topics andschedule are subject to change, please visit • Protocol Development Group Session 3www.vailworkshop.org for updates. • Small Group Discussion Sessions 1-2 • Small Group Discussion Sessions 3-4 • Independent Study Time/Dinner on OwnSaturday, July 28, 2012 • ASSIGNMENT DUE • Registration • Administration of Pretest Tuesday, July 31, 2012 • Protocol Development Group Session I • Continental Breakfast • Dinner • Lecture Session 4 • Break/Group Photo • Protocol Development Group Session 4Sunday, July 29, 2012 • Buffet Lunch • Continental Breakfast • Small Group Discussion Sessions 5-7 • Lecture Session 1 • Office Hours 2: Protocol Related Questions • Buffet Lunch • Independent Study Time/Dinner on Own • Protocol Development Group Session 2 • ASSIGNMENT DUE • Office Hours 1: Protocol Related Questions • Independent Study Time • ASSIGNMENT DUE • Reception • Buffet DinnerW W W . V A I L W O R K S H O P . O R G 5
  • 6. 2012 AACR/ASCO WorkshopMethods in Clinical Cancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, ColoradoTentative Daily Program Some comments from past WorkshopWednesday, August 1, 2012 participants . . . • Continental Breakfast • Lecture Session 5 “With regard to the workshop, all I can say • Protocol Development Group Session 5 is that it was a terrific experience – intense, informative, and extremely helpful in terms • Boxed Lunch of shaping my career as a clinical • Lecture Session 6 researcher.” • Special Interest Group and Career Sessions • Office Hours 3: Any Question Topics (protocol, career, etc.) “Without any doubt, it was perhaps the best • Independent Study Time/Dinner on Own conference that I have ever attended . . . I • ASSIGNMENT DUE especially liked the fact that one arrives with an idea and during the course of the week there is an opportunity to implement thatThursday, August 2, 2012 idea into a solid protocol.” • Continental Breakfast • Lecture Session 7 “The Methods in Clinical Cancer Research • Protocol Development Group Session 6 Workshop was an extremely valuable • Lunch/Buffet learning experience. The lectures covered • Administration of Posttest a broad range of noteworthy topics • Independent Study Time in the design and conduct of clinical • ASSIGNMENT DUE trials, and the presentations were of the • Reception/Banquet/Dance highest caliber.” “The protocol development group leadersFriday, August 3, 2012 clearly took their responsibilities seriously, • Continental Breakfast providing detailed and thoughtful comments • Adjournment and Departure on my protocol, and useful advice for the development of clinical trials in general.”6 W W W . V A I L W O R K S H O P . O R G
  • 7. Online Application Procedure For those protocols using agents from a pharmaceutical company that are not FDA approvedWe are pleased to offer a completely online procedure to for the disease under study, the final application willapply to participate in the AACR/ASCO Workshop on require a letter of commitment from the collaboratingMethods in Clinical Cancer Research. Simply visit the company stating that drug will be supplied for theworkshop website, www.vailworkshop.org, and follow the proposed trial. Priority will be given to applicants thatonscreen instructions. have a letter that is uploaded with the applicationOnly online applications will be considered; paper (preferably a letter of commitment, but at minimum,submissions will not be accepted. we request a letter of intent). If a letter is not included, the application is unlikely to be approved.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 its feasibility (protocols that are largely written before the workshop are not acceptable). Benefits of Attendance:• Your personal C.V. (electronic version). The organizers conduct thorough short- and long-term• A statement explaining why you wish to participate in this evaluations of the workshop to assure that it meets its Workshop. objectives and provides the attendees with the skills they• A statement from your Program Supervisor or need to be effective clinical investigators. Some of the highlights from past evaluations demonstrate the many Department Head or mentor in support of your benefits of attendance: application for this workshop.Detailed instructions for each of these items can be found • Participants of the last 10 workshops have recognized that the workshop is a “must attend” event for theon the online Application Form. Applications will not be advancement of their careers and research training –accepted unless they contain all FIVE elements described 100% of them indicated they would recommend thisabove. The deadline for receipt of online applications is course to someone whose training was similar to theirs.Friday, March 16. • More than two-thirds of the students who attended theFor questions about the application process, contact 2011 workshop were referred to the workshop basedNatalie Konrad, AACR Staff Assistant at (215) 446-7177 or upon the recommendation of a colleague.natalie.konrad@aacr.org. • Participants have rated highly the daily small protocol development group sessions that constitute the core of the workshop. Participants indicated that they received constructive feedback from the faculty in their protocolWorkshop Preparation development group sessions and 96% of the participants departed the workshop with a completed protocol in hand, ready to submit to their IRB for approval.Those accepted for the workshop should come preparedto develop the clinical research concept submitted with • Fully 99% of the attendees indicated that thetheir application into a complete clinical trial protocol organization of the course and scheduling of activities were excellent and that they had many opportunities toduring the course of the workshop. They should bring interact and network with the faculty.their institution’s protocol and informed consenttemplates. A background literature review is required as • Long-term evaluations of the workshop demonstrate the continuing productivity of the graduates. Three yearspreparation for the workshop. They should come with a after the workshop, two-thirds or more of the attendeesdraft of the background section of their protocol. spend substantial time in patient-oriented orParticipants must bring a laptop computer to the translational research and have designed and/orworkshop to facilitate their completion of the daily participated in designing three or more protocols whichassignments. were approved by an IRB and implemented.W W W . V A I L W O R K S H O P . O R G 7
  • 8. 2012 AACR/ASCO WorkshopMethods in Clinical Cancer ResearchJuly 28-August 3, 2012 • Vail Marriott Mountain Resort • Vail, Colorado Full Program Details • Learn from the experts how to design an and Application effective clinical trial of a therapeutic intervention in the treatment of cancer in Procedures Inside any oncologic research subfield • Apply basic therapeutic clinical trial Convenient Online design concepts to any clinical research Application Process specialty, including radiation and surgical oncology and radiology • Avoid costly and embarrassing mistakes Designed for in clinical trial design and implementation Individuals in Any • Understand advanced clinical trial design Clinical Research principles involving multimodality trials Specialty Area • Enhance the validity and reliability of and Radiology clinical trials • Individuals of African American and Hispanic/Latino descent are especially Scholarship Assistance encouraged to apply for All Successful Applicants • Compete to receive either a full scholarship or a stipend to attend, depending upon academic status Application Deadline: March 16, 2012 615 Chestnut Street, 17th Floor • Philadelphia, PA 19106-4404 • 215-440-9300 • Fax: 215-599-0111 • E-mail: programs@aacr.orgW W W . V A I L W O R K S H O P . O R G