State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely theresearch 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 asuccinct 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 Centerfor Experimental Therapeutics (CET) of the University of Pennsylvania School of Medicine submit this requestfor the renewal of an innovative and comprehensive clinical research training program, to support and furtherdevelop existing training in clinical research. Depending on their career focus, Clinical Research CurriculumAward (CRCA) trainees, who are selected from among those interested in careers as independent investigatorsin academic clinical research, may enroll in either the Master of Science in Clinical Epidemiology (MSCE) orthe new Master of Science in Translational Research (MTR) degree program. The core curriculum for bothprograms includes courses in research methods, biostatistics, and bioethics. In addition, an introductorylongitudinal Patient Oriented Research (POR) course and a series of introductory clinical research methodscourses 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 electivecourses, including shared courses in research methods, biostatistics, and bioethics, along with training inscientific writing and federal human subject research policies and regulations, as well as the development andcompletion of an independent research project. The longstanding MSCE degree program is designed to produceskilled investigators trained to design and conduct formal clinical research studies of all types. With supportfrom 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 degreeprogram, 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 laboratoryfindings 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 supportprovided by the initial CRCA, seek to recruit promising junior faculty, residents, and fellows into the fields ofpatient-oriented research. The semester-long and summer short courses covering introductory clinical researchmethods and topics, offered for the first time in 2003-04, are designed to introduce faculty, residents, andfellows to clinical research. The nine-month introductory POR course provides an overview of biostatistics, trialdesign, 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 expertisein clinical research; the comprehensive course offerings and training options available to trainees; andcollaborative 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 andmentors; and the demonstrated success of the initial CRCA. In addition, the proposed program benefits from theavailability of the NIH-funded General Clinical Research Center (GCRC), an integrative resource that is usedextensively by the CCEB, LDI, and CET. Additional resources include extensive and newly developedlaboratories, large databases available for research projects, a range of specialized analytic capabilities, and thecommitment, 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, PAKEY PERSONNEL. See instructions on Page 11. Use NameBrian L. Strom, MD, MPHGarret FitzGerald, MD, MScJ. Sanford Schwartz, MDJason Christie, MD, MSCEJohn Farrar, MD, MSCEEmma Meagher, MDPeter Adamson, MDPHS 398 (Rev. 05/01)continuation pages as needed to provide OrganizationUniversity of PennsylvaniaUniversity of PennsylvaniaUniversity of PennsylvaniaUniversity of PennsylvaniaUniversity of PennsylvaniaUniversity of PennsylvaniaUniversity of Pennsylvania 2Page mthe required information in the format shown below. Role on ProjectPrincipal Investigator/Primary Preceptor/Course DirectorCo-Principal Investigator/Primary PreceptorCo-Principal Investigator/Primary PreceptorAcademic Coordinator/Course DirectorAcademic Coordinator/Primary Preceptor/Course DirectorAcademic Coordinator/Course DirectorPrimary PreceptorForm Page 2Principal Investigator/ProgramSteven Albelda, MD UniversityRichard Aplenc, MD, MSCE UniversityKatrina Armstrong, MD, MSCE UniversityDavid Asch, MD, MBA UniversityKurt Barnhart, MD, MSCE UniversityScarlett Bellamy, ScD UniversityJesse A. Berlin, ScD UniversityWarren Bilker, PhD UniversityAnne Blackwood-Chirchir, MD UniversityRaymond Boston, PhD UniversityCharles Branas, PhD UniversityR. Nick Bryan, MD UniversityGreta Bunin, PhD UniversityZhen Chen, PhD UniversityAlan R. Cohen, MD UniversityAndrew Cucchiara, PhD UniversityAngela DeMichele, MD, MSCE UniversityDennis Durbin, MD, MSCE UniversityMichael Elliott, Phi) UniversityStephen Emerson, MD UniversityDwight L. Evans, MD UniversityHarold Feldman, MD, MSCE UniversityAron B. Fisher, MD UniversityAndrea Foulkes, ScD UniversityJoseph Gallo, MD, MPH UniversityGlen N. Gaulton, PhD UniversityPhyllis Gimotty, PhD UniversityJohn H. Glick, MD UniversityDuPont Guerry, MD UniversityWensheng Guo, PhD UniversityJohn Hansen-Flaschen, MD UniversityTrevor R. Hadley, PhD UniversityDaniel Heitjan, PhD UniversityJohn H. Holmes, PhD UniversityWilliam Holmes, MD, MSCE UniversityWei-Ting Hwang, PhD UniversityMarshall Joffe, MD, PhD UniversityCarl June, MD UniversityStephen Kimmel, MD, MSCE UniversityBarbara A. Konkle, MD UniversityShiriki Kumanyika, PhD, MPH UniversityJ. Richard Landis, Phi) UniversityEbbing Lautenbach, MD, MSCE, University MPHMary Leonard, MD, MSCE UniversityJames Lewis, MD, MSCE UniversityA. Russell Localio, JD, MPH, MS, University MAGeorge Macones, MD, MSCE UniversityDavid Margolis, MD, MSCE UniversityMichael T. Mennuti, MD UniversityPHS 398 (Rev. 05/01)Director (Last, first, middle): Strom, Brian L.of Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvania of Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvaniaof Pennsylvania3PagePrimary PreceptorCourse DirectorPrimary PreceptorPrimary PreceptorPrimary Preceptor/Course DirectorBiostatistics AdvisorBiostafistics AdvisorBiostatistics Advisor/Course DirectorPrimary Preceptor/Course DirectorBiostafistics AdvisorPrimary Preceptor/Course DirectorPrimary Preceptor/Course DirectorPrimary PreceptorBiostatistics Advisor CRCA Advisory CommitteeBiostatistics 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 DirectorPrimary PreceptorPrimary Preceptor/Course DirectorBiostatistics Advisor/Course DirectorPrimary Preceptor/Course DirectorPrimary Preceptor/Course DirectorCRCA Advisory CommitteeForm Page 2Principal Investigator/Program Director (Last, first,Joshua Metlay, MD, PhD University of PennsylvaniaDeborah B. Nelson, PhD University of PennsylvaniaAllan Pack, MD, PhD University of PennsylvaniaMichael S. Parmacek, MD University of PennsylvaniaKathleen Propert, ScD University of PennsylvaniaMary Putt, PhD, ScD University of PennsylvaniaReed Pyeritz, MD University of PennsylvaniaDaniel Rader, MD University of PennsylvaniaSteven Raper, MD University of PennsylvaniaSarah Ratcliffe, PhD University of PennsylvaniaTimothy Rebbeck, PhD University of PennsylvaniaSusan R. Ross, PhD University of PennsylvaniaMargaret Rukstalis, MD University of PennsylvaniaAnil K. Rustgi, MD University of PennsylvaniaMary Sammel, ScD University of PennsylvaniaDavid M. Shera, ScD University of PennsylvaniaJustine Shults, PhD University of PennsylvaniaJeffrey Silber, MD, PhD University of PennsylvaniaSeema Sonnad, PhD University of PennsylvaniaJohn R. Stanley, MD University of PennsylvaniaMargaret Stineman, MD University of PennsylvaniaKaren L. Teff, PhD University of PennsylvaniaThomas Ten Have, PhD University of PennsylvaniaJohn E. Tomaszewski, MD University of PennsylvaniaAndrea Troxel, ScD University of PennsylvaniaBarbara Weber, MD University of PennsylvaniaSankey Williams, MD University of PennsylvaniaSharon Xie, PhD University of Pennsylvaniamiddle): Strom, Brian L.Primary PreceptorPrimary Preceptor/Course DirectorPrimary PreceptorCRCA Advisory CommitteeBi0statistics AdvisorBiostatistics AdvisorPrimary PreceptorPrimary PreceptorPrimary PreceptorBiostatistics AdvisorPrimary Preceptor/Course DirectorCRCA Advisory CommitteePrimary PreceptorCRCA Advisory CommitteeBiostatistics AdvisorBiostatistics AdvisorBiostatistics AdvisorPrimary 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 asmember. Each role is definedPrimary PreceptorBiostatistics AdvisorCourse DirectorCRCA Advisory CommitteeAcademic Coordinatora preceptor, biostatistics advisor, course director, and/or CRCA Advisory Committee below.mentor; provide general academic advice, methodologic and other study designadvice, career advice, quality of life; meet regularlyprovide biostatistics advice, primarily on an as-needed basis during all phases of theresearch project, as appropriate, particularly during the protocol development anddata analysis phases (as appropriate, serves as the biostatistics member of the thesiscommittee)course director or co-course director for a required course (the core courses) and forselected elective coursesSOM Senior Faculty member and Department Chair, Division Chief, Center Director,or Program Director, providing oversight for this comprehensive clinical researchtraining programresponsible for the day-to-day academic activities of specific programs, includingproviding oversight for curriculum development; maintenance and review of degreerequirements, as appropriate; trainee mentoring, as appropriate; review and approvalof new courses; and ongoing evaluation of existing courses 4PHS 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
| Wong, Yu-Ning; Mitra, Nandita; Hudes, Gary et al. (2006) Survival associated with treatment vs observation of localized prostate cancer in elderly men. JAMA 296:2683-93 |
