MD Anderson Clinical Trial Methods & Design Workshop for Junior Faculty

March 6-9, 2014 Off-site location will be announced November 1st

Call for Applications Submission Deadline 5 p.m., Monday, November 18, 2013

Workshop Committee Chairs Kelly Hunt, MD (Chair)* Professor, Surgical Oncology Bonnie Glisson, MD (Co-Chair)* Professor, Thoracic Head & Neck Medical Oncology

Bruce Minsky, MD (Co-Chair)* Deputy Division Head, Radiation Oncology

Workshop Program Committee & Faculty Speakers Kenneth Aldape, MD Professor and Chair, Pathology Keith Baggerly, PhD* Professor, Bioinformatics & Computational Biology Paul Brown, MD Professor, Radiation Oncology Powel Brown, MD, PhD Professor and Chair, Clinical Cancer Prevention Aman Buzdar, MD Vice President, Clinical Research Administration Laurence Cooper, MD, PhD* Professor, Pediatrics Jorge Cortes, MD Professor, Leukemia Ethan Dmitrovsky, MD* Provost and Executive Vice President Cathy Eng, MD* Associate Professor, GI Medical Oncology Mark Gilbert, MD Professor, Neuro-Oncology Kenneth Hess, PhD Professor, Biostatistics John Heymach, MD, PhD* Professor and Chair, Thoracic Head & Neck Medical Oncology David Hong, MD* Associate Professor, Investigational Cancer Therapeutics Waun Ki Hong, MD* Head, Division of Cancer Medicine Patrick Hwu, MD Professor and Chair, Melanoma and Sarcoma Medical Oncology J. Jack Lee, PhD* Professor, Biostatistics Funda Meric-Bernstam, MD* Professor and Chair, Investigational Cancer Therapeutics Elizabeth Mittendorf, MD, PhD* Professor, Surgical Oncology Jeffrey Myers, MD, PhD Professor, Head & Neck Surgery Eric Rohren, MD, PhD* Associate Professor, Nuclear Medicine Steven Sherman, MD* Professor and Chair, Endocrine Neoplasia & Hormonal Disorders Michael Wallace, MD* Professor and Chair (ad-interim), Interventional Radiology Ignacio Wistuba, MD* Professor and Chair, Translational Molecular Pathology Xifeng Wu, MD, PhD Professor and Chair, Epidemiology

*Faculty Speaker

Goals of the Workshop The MD Anderson Clinical Trials Methods and Design Workshop will utilize didactic lectures, small group discussions, and one-on-one interactions with senior and highly experienced clinical investigators to assist competitively selected junior faculty (defined as Assistant Professors, or Associate Professors within the first 3 years of their appointment) in the development of high quality, feasible, and innovative clinical research. Over an intensive 4-day weekend at an off-campus retreat, each workshop participant will work with multidisciplinary investigators to develop a novel concept as an MD Anderson Protocol Abstract, as a first step in the finalization of a full, actionable clinical protocol.

Educational Objectives • To cultivate thought-leaders in clinical research.

• To facilitate the development of high-impact clinical trials to improve patient treatment options.

• To integrate ground-breaking translational research in novel trial designs.

• To define Principal Investigator (PI) responsibilities and identify “best practices” for the conduct of cancer clinical trials.

Workshop Session Format The scientific program for the workshop consists of four educational formats led by experienced clinical research faculty to serve a variety of didactic needs:

• Protocol development group sessions, during which each participant, through extensive mentoring, designs and completes the writing of the protocol abstract before the end of the workshop. These sessions constitute the core activity of the workshop and allow participants to apply the lessons being learned in the workshop to their own clinical studies and receive detailed critiques of their protocol abstracts from experienced scientists.

• Lectures on specific topics presented by experts in the field. These talks will give participants an essential overview of the field and of the principles of design and conduct of high-quality clinical trials. Some lectures are followed by panel discussions or case studies so students and faculty can explore issues in greater depth.

• Small group discussion sessions on special topics, such as integrating laboratory correlates, imaging endpoints in clinical trials, and best practices of a study PI. These session topics are often key to the success of many different kinds of clinical trials and offer an opportunity for in-depth discussion on topics of special interest to clinical investigators.

• Faculty “office hours,” to provide time for individual mentoring and advice on protocol development.

MD Anderson Clinical Trial Methods & Design Workshop for Junior Faculty March 6-9, 2014

Selection of Junior Faculty Participants The faculty program committee will accept applications from junior faculty only (defined as Assistant Professors, or Associate Professors within the first 3 years of appointment). Selection of the workshop participants will be limited to 45 applicants, and based on the scientific merit of the proposed concept, clarity and detail of the application components, and strength of the Department Chair’s letter of support.

Eligible applicants will have demonstrated a high level of commitment and competence in clinical cancer research, as well as a keen interest in enhancing their skills and knowledge of clinical trial design and conduct. The 45 selected participants will be required to pay a $500 registration fee for the workshop (faculty PRS funds will be accepted). Applicants will be notified of their status by January 15, 2014.

Workshop participants will receive complimentary shuttle bus transportation to/from the workshop (approximately 3 hours each way), hotel accommodations for the nights of March 6 – 8, 2014, and meals throughout the workshop. All participants are required to bring their own laptops for study development and to complete workshop assignments; all other workshop materials will be provided.

Application Process Applicants must submit a completed application form and supporting materials electronically as one pdf attachment to Mellanie Price at mejprice@mdanderson.org by November 18, 2013, at 5 p.m. Candidates can access the workshop application electronically via the institutional calendar.

A completed application includes the following items:

• The Application Form, which includes a brief personal statement explaining why the candidate wishes to participate in this Workshop (limited to 250 words).

• A one-page description of an original clinical trial concept that is proposed for development as an MD Anderson Abstract during the workshop.

• A sponsor Letter of Intent to indicate internal or external study funding source and/or availability of proposed agent/device.

• The applicant’s updated, NIH-formatted Biosketch (limited to 4 pages).

Please note that applications need to contain all four elements described above within the single pdf attachment to be accepted for consideration. Incomplete applications will be returned without review.

Department Chair Letter of Support: A letter of support for the applicant or a single letter referencing each applicant from that department must be submitted separately by the Department Chair as one pdf attachment to Mellanie Price at mejprice@mdanderson.org by 5 p.m., Monday, November 18, 2013. This letter must include specific statements assessing the scientific merit and feasibility of the proposed concept and the commitment of the applicant towards a career in clinical research. Applications that do not have a Department Chair letter referencing that applicant submitted separately by the due date will be returned without review.

Workshop Preparation Junior faculty accepted for the workshop should come prepared to develop an MD Anderson Protocol Abstract, utilizing the institution’s abstract template, based on the clinical research concept submitted with their application. A thorough literature review of each workshop participant’s concept area is required as preparation for the workshop. Participants should have an updated draft of the concept, including a brief background section, available for discussion at the first small group session (Thursday evening, March 6th). Participants should bring a laptop computer to the workshop to facilitate completion of their daily assignments and finalization of their Protocol Template.

Questions For questions regarding the workshop and application requirements:

• Contact Mellanie Price, associate director, Office of the Vice Provost, Clinical Research, via email at mejprice@mdanderson.org or phone at 713-792-4392.

• Visit the institutional calendar to access the workshop program, brochure and application.

MD Anderson Clinical Trial Methods & Design Workshop for Junior Faculty General Workshop Information

MD ANDERSON CLINICAL TRIALS METHODS AND DESIGN WORKSHOP FOR JUNIOR FACULTY

Application Cover Page

DEADLINE FOR ELECTRONIC SUBMISSION OF ALL MATERIALS:

5:00 p.m., November 18, 2013

Please submit all application materials as one pdf attachment to Mellanie Price at mejprice@mdanderson.org

Questions? Call: (713) 792-1657

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Name of Applicant: ______________ Title of Study Concept: _____________________________________________________

Contact Information:

Department: ____________________________________________________________

Mailing Address: _________________________________________________________

Phone: __________________________ Email: __________________________

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Applications must include all of the following as one pdf attachment sent electronically:

1. Application cover page (with completed personal statement) 2. The Applicant’s current NIH-formatted Biosketch 3. Study Concept (1-page limit including figures, excluding references) 4. Sponsor Letter of Intent to indicate internal or external study funding source and/or

availability of agent/device Note: A single Letter of Support from the Department Chair referencing each junior faculty applicant from that department must be submitted separately, in pdf format, to Mellanie Price at mejprice@mdanderson.org by 5pm, Monday, November 18, 2013. This letter must include statements assessing the scientific merit and feasibility of each proposed concept and the commitment of each applicant towards a career in clinical research.

All selected participants will be required to submit a $500 registration fee payment by January 15, 2014. Payment instructions will be forwarded with the notification of a participant’s selection.

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Applicant’s Personal Statement (limit: 250 words):

Please indicate why you wish to participate in this Workshop and its potential impact on your

career: