Clinical Researach Curriculum Award

DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. DO NOT EXCEED THE SPACE PROVIDED. The Center for Clinical Epidemiology and Biostatistics (CCEB), Leonard Davis Institute (LDI), and Center for Experimental Therapeutics (CET) of the University of Pennsylvania School of Medicine submit this request for the renewal of an innovative and comprehensive clinical research training program, to support and further develop existing training in clinical research. Depending on their career focus, Clinical Research Curriculum Award (CRCA) trainees, who are selected from among those interested in careers as independent investigators in academic clinical research, may enroll in either the Master of Science in Clinical Epidemiology (MSCE) or the new Master of Science in Translational Research (MTR) degree program. The core curriculum for both programs includes courses in research methods, biostatistics, and bioethics. In addition, an introductory longitudinal Patient Oriented Research (POR) course and a series of introductory clinical research methods courses are offered to junior faculty, residents, and fellows, whose research interests still are emerging. Both the MSCE and MTR programs are 2-3 year full time programs consisting of core and elective courses, including shared courses in research methods, biostatistics, and bioethics, along with training in scientific writing and federal human subject research policies and regulations, as well as the development and completion of an independent research project. The longstanding MSCE degree program is designed to produce skilled investigators trained to design and conduct formal clinical research studies of all types. With support from the initial CRCA, this program was substantially expanded and improved and now includes five Tracks: Epidemiology, Health Services Research, Human Genetics, Bioethics, and Clinical Trials. The MTR degree program, developed recently with support provided by the initial CRCA, and which emphasizes mechanism- based translational research, is designed to produce skilled investigators who are trained to apply laboratory findings to patients in the conduct of mechanism of human physiology and disease research. The POR and introductory clinical research methods courses, developed and/or expanded with support provided by the initial CRCA, seek to recruit promising junior faculty, residents, and fellows into the fields of patient-oriented research. The semester-long and summer short courses covering introductory clinical research methods and topics, offered for the first time in 2003-04, are designed to introduce faculty, residents, and fellows to clinical research. The nine-month introductory POR course provides an overview of biostatistics, trial design, regulatory affairs, and the mechanics underlying the drug approval process. The strengths of the proposed program are the School of Medicine's exceptional track record of NIH- supported clinical research and training; the institutional emphasis on and support for development of expertise in clinical research; the comprehensive course offerings and training options available to trainees; and collaborative links that already have been forged among the CCEB, LDI, and CET; an outstanding, multi- disciplinary faculty comprised of highly committed and successful independent clinical investigators and mentors; and the demonstrated success of the initial CRCA. In addition, the proposed program benefits from the availability of the NIH-funded General Clinical Research Center (GCRC), an integrative resource that is used extensively by the CCEB, LDI, and CET. Additional resources include extensive and newly developed laboratories, large databases available for research projects, a range of specialized analytic capabilities, and the commitment, expertise, and unusually complementary track records of the PI and co-PIs in epidemiology, health services research, and mechanism-based research. PERFORMANCE SITE(S) (organization, city, state) UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA KEY PERSONNEL. See instructions on Page 11. Use Name Brian L. Strom, MD, MPH Garret FitzGerald, MD, MSc J. Sanford Schwartz, MD Jason Christie, MD, MSCE John Farrar, MD, MSCE Emma Meagher, MD Peter Adamson, MD PHS 398 (Rev. 05/01) continuation pages as needed to provide Organization University of Pennsylvania University of Pennsylvania University of Pennsylvania University of Pennsylvania University of Pennsylvania University of Pennsylvania University of Pennsylvania 2 Page m the required information in the format shown below. Role on Project Principal Investigator/Primary Preceptor/ Course Director Co-Principal Investigator/Primary Preceptor Co-Principal Investigator/Primary Preceptor Academic Coordinator/Course Director Academic Coordinator/Primary Preceptor/ Course Director Academic Coordinator/Course Director Primary Preceptor Form Page 2 Principal Investigator/Program Steven Albelda, MD University Richard Aplenc, MD, MSCE University Katrina Armstrong, MD, MSCE University David Asch, MD, MBA University Kurt Barnhart, MD, MSCE University Scarlett Bellamy, ScD University Jesse A. Berlin, ScD University Warren Bilker, PhD University Anne Blackwood-Chirchir, MD University Raymond Boston, PhD University Charles Branas, PhD University R. Nick Bryan, MD University Greta Bunin, PhD University Zhen Chen, PhD University Alan R. Cohen, MD University Andrew Cucchiara, PhD University Angela DeMichele, MD, MSCE University Dennis Durbin, MD, MSCE University Michael Elliott, Phi) University Stephen Emerson, MD University Dwight L. Evans, MD University Harold Feldman, MD, MSCE University Aron B. Fisher, MD University Andrea Foulkes, ScD University Joseph Gallo, MD, MPH University Glen N. Gaulton, PhD University Phyllis Gimotty, PhD University John H. Glick, MD University DuPont Guerry, MD University Wensheng Guo, PhD University John Hansen-Flaschen, MD University Trevor R. Hadley, PhD University Daniel Heitjan, PhD University John H. Holmes, PhD University William Holmes, MD, MSCE University Wei-Ting Hwang, PhD University Marshall Joffe, MD, PhD University Carl June, MD University Stephen Kimmel, MD, MSCE University Barbara A. Konkle, MD University Shiriki Kumanyika, PhD, MPH University J. Richard Landis, Phi) University Ebbing Lautenbach, MD, MSCE, University MPH Mary Leonard, MD, MSCE University James Lewis, MD, MSCE University A. Russell Localio, JD, MPH, MS, University MA George Macones, MD, MSCE University David Margolis, MD, MSCE University Michael T. Mennuti, MD University PHS 398 (Rev. 05/01) Director (Last, first, middle): Strom, Brian L. of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania of Pennsylvania 3 Page Primary Preceptor Course Director Primary Preceptor Primary Preceptor Primary Preceptor/Course Director Biostatistics Advisor Biostafistics Advisor Biostatistics Advisor/Course Director Primary Preceptor/Course Director Biostafistics Advisor Primary Preceptor/Course Director Primary Preceptor/Course Director Primary Preceptor Biostatistics Advisor CRCA Advisory Committee Biostatistics Advisor Primary Preceptor/Course Director Primary Preceptor/Course Director Biostatistics Advisor Primary Preceptor CRCA Advisory Committee Primary Preceptor CRCA Advisory Committee Biostatistics Advisor Primary Preceptor/Course Director CRCA Advisory Committee Biostatistics Advisor CRCA Advisory Committee Primary Preceptor Biostatistics Advisor CRCA Advisory Committee CRCA Advisory Committee Biostatistics Advisor Course Director Course Director Biostatistics Advisor Biostatistics Advisor Primary Preceptor Primary Preceptor/Course Director Primary Preceptor Primary Preceptor Biostatistics Advisor/Course Director Primary Preceptor/Course Director Primary Preceptor Primary Preceptor/Course Director Biostatistics Advisor/Course Director Primary Preceptor/Course Director Primary Preceptor/Course Director CRCA Advisory Committee Form Page 2 Principal Investigator/Program Director (Last, first, Joshua Metlay, MD, PhD University of Pennsylvania Deborah B. Nelson, PhD University of Pennsylvania Allan Pack, MD, PhD University of Pennsylvania Michael S. Parmacek, MD University of Pennsylvania Kathleen Propert, ScD University of Pennsylvania Mary Putt, PhD, ScD University of Pennsylvania Reed Pyeritz, MD University of Pennsylvania Daniel Rader, MD University of Pennsylvania Steven Raper, MD University of Pennsylvania Sarah Ratcliffe, PhD University of Pennsylvania Timothy Rebbeck, PhD University of Pennsylvania Susan R. Ross, PhD University of Pennsylvania Margaret Rukstalis, MD University of Pennsylvania Anil K. Rustgi, MD University of Pennsylvania Mary Sammel, ScD University of Pennsylvania David M. Shera, ScD University of Pennsylvania Justine Shults, PhD University of Pennsylvania Jeffrey Silber, MD, PhD University of Pennsylvania Seema Sonnad, PhD University of Pennsylvania John R. Stanley, MD University of Pennsylvania Margaret Stineman, MD University of Pennsylvania Karen L. Teff, PhD University of Pennsylvania Thomas Ten Have, PhD University of Pennsylvania John E. Tomaszewski, MD University of Pennsylvania Andrea Troxel, ScD University of Pennsylvania Barbara Weber, MD University of Pennsylvania Sankey Williams, MD University of Pennsylvania Sharon Xie, PhD University of Pennsylvania middle): Strom, Brian L. Primary Preceptor Primary Preceptor/Course Director Primary Preceptor CRCA Advisory Committee Bi0statistics Advisor Biostatistics Advisor Primary Preceptor Primary Preceptor Primary Preceptor Biostatistics Advisor Primary Preceptor/Course Director CRCA Advisory Committee Primary Preceptor CRCA Advisory Committee Biostatistics Advisor Biostatistics Advisor Biostatistics Advisor Primary Preceptor/Course Director Course Director CRCA Advisory Committee Primary Preceptor Primary Preceptor Biostatistics Advisor CRCA.Advisory Committee Biostatistics Advisor Primary Preceptor Primary Preceptor/Course Director Biostatistics Advisor/Course Director *Key personnel will serve as member. Each role is defined Primary Preceptor Biostatistics Advisor Course Director CRCA Advisory Committee Academic Coordinator a preceptor, biostatistics advisor, course director, and/or CRCA Advisory Committee below. mentor; provide general academic advice, methodologic and other study design advice, career advice, quality of life; meet regularly provide biostatistics advice, primarily on an as-needed basis during all phases of the research project, as appropriate, particularly during the protocol development and data analysis phases (as appropriate, serves as the biostatistics member of the thesis committee) course director or co-course director for a required course (the core courses) and for selected elective courses SOM Senior Faculty member and Department Chair, Division Chief, Center Director, or Program Director, providing oversight for this comprehensive clinical research training program responsible for the day-to-day academic activities of specific programs, including providing oversight for curriculum development; maintenance and review of degree requirements, as appropriate; trainee mentoring, as appropriate; review and approval of new courses; and ongoing evaluation of existing courses 4 PHS 398 (Rev. 05/01) Page _ Form Page 2 ¿ Principal Investigator/Program Director (Last, first, middle): Strom, Brian L. The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. Type density and size must conform to limits and specifications provided in the PHS 398 Instructions. RESEARCH GRANT