MASTER OF SCIENCE DEGREE IN CLINICAL INVESTIGATION

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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. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. This application is a competing renewal for the University of Texas Health Science Center at San Antonio's (UTHSCSA) Clinical Research Curriculum Award (NHLBI K30 HL04159). Over the past 3 years we successfully established a new Masters of Science in Clinical Investigation (MSCI) Degree Program and enrolled a diverse group of 26 students; 5 (19.2%) have already been successful in obtaining peer reviewed grant funding. With this application we seek to achieve 2 specific aims: 1) enhance and expand the quality of clinical research training for post-doctoral students, graduates, and faculty from all 5 of the UTHSCSA's schools, and 2) further increase the diversity of the students, in ethnicity and professional background, trained in the conduct of clinical research. The 'laboratory' for our trainees is the General Clinical Research Center, an NIH-funded center located in one of our teaching hospitals. By linking with our Hispanic Centers of Excellence, the number of ethnically diverse students, particularly Mexican-Americans and other Hispanic groups, trained in clinical research will continue to increase. Once trained, this program's graduates will be expert in the design and conduct of patient-oriented investigations. The preceptors for the MSCI program are faculty members with active programs in molecular biology, protein chemistry, cell biology and clinical research, and who have proven expertise in running successful research programs, research education programs, and in obtaining extramural grant support. Since most MDs lack the formal didactic training characteristic of PhD programs in this arena, we have established an organized program to prepare our trainees as future independent clinical researchers. MSCI candidate complete a mentored research project over 2 years while participating in an integrated set of 11 didactic courses: (a) Research Methods (3 semesters); (b) Biostatistics (3 semesters); (c) Responsible Conduct of Research (1 semester); (d) Integration of Molecular Biology into Clinical Research (1 semester); (e) Data management and Quality Control (1 semester); (f) Scientific Writing (1 semester); and Health Services Research (1 semester - a new course proposed in this application). Our goal is to continually improve the preparation of investigators skilled in the conduct of outstanding clinical research in culturally diverse settings. MSCI program effectiveness will be ascertained by monitoring a cohesive set of 4 primary outcomes. These outcomes are the number of: (a) graduates who continue in clinical research careers (and their roles); (b) graduates who successfully compete for career development and research awards; (c) scientific peer-reviewed publications of the graduates; (d) graduates engaged in mentoring other clinical investigators. PERFORMANCE SITE(S) (organization, city, state) University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229-3900 KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Michael J. Lichtenstein UTHSCSA-Medical School Program Director Jacques Baillargeon UTHSCSA-Medical School Course Leader-Biostatistics John Cornell UTHSCSA-Medical School Course Leader-Biostatistics Sharon Fowler UTHSCSA-Medical School Course Co-Leader-Data Management Goutam Ghosh-Choudhury UTHSCSA-Medical School Course Co-Leader-Molecular Biology Angela Khan UTHSCSA Course Leader-Responsible Conduct Bettie Sue Masters UTHSCSA-Graduate School Course Co-Leader-Methods Polly NoeI-Hitchcock UTHSCSA-Medical School Course Co-Leader-Health Services Research Michael Parchman UTHSCSA-Medical School Course Co-Leader-Health Services Research Brad Pollock UTHSCSA-Medical School Course Co-Leader-Biostatistics Jacqueline Pugh UTHSCSA-Medical School Course Leader-Health Services Research Steven Schenker UTHSCSA-Medical School Course Leader-Responsible Conduct John Schoolfield UTHSCSA-Academic Informatics Course Co-Leader-Biostatistics Zelton Dave Sharp UTHSCSA-Medical School Course Leader-Scientific Writing Linda A. Smith UTHSCSA-School of Allied Health Course Co-Leader-Molecular Biology Michael P. Stern UTHSCSA-Medical School Course Leader-Data Management Kenneth Williams UTHSCSA-Medical School Course Co-Leader, Data Management PHS 398 (Rev. 05/01 ) Page _2 Form Page 2 Principal Investigator/Program Director (Last, first, middle): Lichtenstein, Michael J.