2 Annual Clinical Trial Methods & Design Workshop for Junior Faculty

Transcription

1 The University of Texas MD Anderson Cancer Center nd 2 Annual Clinical Trial Methods & Design Workshop for Junior Faculty May 7-9, 2015 The Houstonian Hotel, Houston, Texas Sponsored by The Office of the Vice Provost, Clinical Research Call for Applications Submission Deadline 5 p.m., Thursday, January 15, 2015 Funding support generously provided by the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy

2 The University of Texas MD Anderson Cancer Center 2nd Annual Clinical Trial Methods & Design Workshop for Junior Faculty May 7-9, 2015 Goals of the Workshop The 2nd Annual 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) and clinical fellows expected to join as MDACC faculty in 2015 in the development of high quality, feasible, and innovative clinical research. Over an intensive 3-day weekend at an off-campus retreat, workshop participants will work with multidisciplinary investigators to develop their novel concepts 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 PI responsibilities and identify best practices for the conduct of cancer clinical trials. Application Process To apply for the MD Anderson Clinical Trials Methods and Design Workshop, candidates must complete and submit the following: A completed Application Form, including a personal statement explaining why you wish to participate in this Workshop (limited to 250 words). A one-page description of an original clinical trial concept you intend to develop as an MD Anderson Abstract during the workshop. A Letter of Intent to indicate internal or external study funding source and/or availability of proposed agent/device. An updated NIH-formatted Biosketch. Letter of Support: A single Letter of Support from the Department Chair referencing each junior faculty or clinical fellow applicant from that department must be submitted separately. This letter must include statements assessing the scientific merit, feasibility, departmental approval of each proposed concept, and the commitment of each applicant towards a career in clinical research. Application Deadline: Thursday, January 15, 5 pm A registration fee of $500 will be required for all participants selected to participate. For questions about the workshop or the application process, please contact Ms. Mellanie Price by at mejprice@mdanderson.org or by phone at (713)

3 2 nd Annual MD Anderson Clinical Trial Methods & Design Workshop for Junior Faculty General Workshop Information 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. Selection of Junior Faculty Participants The faculty program committee will accept applications from junior faculty (defined as Assistant Professors, or Associate Professors within the first 3 years of appointment) and clinical fellows expected to join as MDACC faculty in Selection of the workshop participants will be limited to 35 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 35 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 February 15, All participants are required to bring their own laptops for study development and to complete workshop assignments; all other workshop materials will be provided. 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 available for discussion and be prepared to present an overview of their concept at the first small group session (Thursday, May 7 th ). Participants should bring a laptop computer to the workshop to facilitate completion of their daily assignments and finalization of their protocol template and concept presentation. Questions For questions regarding the workshop and application requirements: Contact Mellanie Price, associate director, Office of the Vice Provost, Clinical Research, via at mejprice@mdanderson.org or phone at Visit the institutional calendar to access the workshop program, brochure and application. Application Deadline: Thursday, January 15, 5 pm Funding support generously provided by the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy

4 2 nd Annual MD Anderson Clinical Trial Methods & Design Workshop for Junior Faculty May 7 th 9 th, 2015 Workshop Program Chairs Kelly Hunt, MD (Co-Chair)* Professor, Surgical Oncology Workshop Program Chairs Bonnie Glisson, MD (Co-Chair)* Professor, Thoracic Head & Neck Medical Oncology Workshop Program Chairs Bruce Minsky, MD (Co-Chair)* Division Head (ad interim), Radiation Oncology Workshop Program Faculty Speakers & Group Leaders Keith Baggerly, PhD* Professor, Bioinformatics & Computational Biology Charles Cleeland, MD* Professor and Chair, Symptom Research Jorge Cortes, MD* Professor, Leukemia Christopher Crane, MD Professor, Radiation Oncology Najat Bitar Daw, MD Professor, Pediatrics Patient Care Kim-Anh Do, PhD Professor and Chair, Biostatistics Cathy Eng, MD* Professor, Gastrointestinal Medical Oncology Renato Ferrarotto, MD* Assistant Professor, Thoracic Head & Neck Medical 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 J. Jack Lee, PhD* Associate Vice Provost, Quantitative Research Funda Meric-Bernstam, MD* Professor and Chair, Investigational Cancer Therapeutics Elizabeth Mittendorf, MD, PhD* Associate Professor, Surgical Oncology Muzaffar Qazilbash, MD Professor, Stem Cell Transplantation & Cellular Therapy Eric Rohren, MD, PhD* Professor, Nuclear Medicine Alda Tam, MD* Associate Professor, Interventional Radiology Michael Wallace, MD Professor and Chair (ad-interim), Interventional Radiology Ignacio Wistuba, MD* Professor and Chair, Translational Molecular Pathology Yuan Ying, PhD Associate Professor, Biostatistics Aradhana Venkatesan, MD Associate Professor, Diagnostic Radiology *Faculty Speaker For more information, please contact: Mellanie Price, Associate Director Clinical Research Office of the Vice Provost, Clinical Research Phone: mejprice@mdanderson.org

5 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., January 15, 2015 Please submit all application materials as one pdf attachment to Mellanie Price at Questions? Call: (713) ************************************************************************************************************* Name of Applicant: Title of Study Concept: Contact Information: Department: Mailing Address: Phone: ************************************************************************************************************* 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 or clinical fellow applicant from that department must be submitted separately, in pdf format, to Mellanie Price at mejprice@mdanderson.org by 5pm, Thursday, January 15, This letter must include statements assessing the scientific merit, feasibility, department approval 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 March 1, Payment instructions will be forwarded with the notification of a participant s selection. *************************************************************************************************************

6 Applicant s Personal Statement (limit: 250 words): Please indicate why you wish to participate in this Workshop and its potential impact on your career: