University of Southern California

  The Primary vision for the Center for Human Studies (CHS) is to transform our highly successful General Clinical Research Center (GCRC) program into the CHS to serve as the bridge between important discoveries of novel therapeutic, diagnostic and mechanistic approaches from the Center for Scientific Translation (CST) and the application of those approaches to better health by the Center for Community Translation (CCT). The CHS will serve as the nexus for clinical testing and as a training ground for promising new clinical investigators in the setting of an unparalleled subject population. The subject-participant constituency of the Los Angeles basin will foster studies to evaluate the effects of race and ethnicity in developing better and safer therapies as needed for the local communities at risk.

  The principle academic partners of the existing clinical research programs include the University of Southern California (USC) and Childrens Hospital Los Angeles (CHLA).  During the transition from the GCRC to the CHS, a number of clinical and community affiliates will partner with the CHS to implement important goals and objectives.  The specific aims include plans to develop mechanisms 1) to promote and support a broader range of clinical research by expanding facilities to accommodate greater volume, especially outpatient testing, developing new mechanisms to support studies being conducted outside CHS space, both within and outside of our academic health centers, and overcoming barriers to collaboration between institutions, including implementation of integrated IRB services and the provision of videoconferencing and computer interfacing to enhance communications, 2) to develop new mechanisms to support the conduct of clinical trials by providing assistance (especially for Investigational New Drugs/Investigational Devices [IND/IDE] applications), and training in regulatory affairs providing didactic and practical training in principles of Good Clinical Practice (GCP) and high standards of ethical conduct in clinical research, integrating our QA-safety program to develop common standards and practices across the CTSI, and implementing informatics support for trials management, 3) to develop new methods for promoting academic-industry relationships in clinical research by establishing integrated National Center for Research Resources (NCRR) and industry funded Clinical Trials Units (CTUs) and to expand relationships with industry to promote greater opportunities to translate potentially important laboratory discoveries, and 4) to develop approaches to identify, recruit and train new clinical researchers by screening faculty candidates through the Faculty Research Council and Faculty Appointment Promotion and Tenure Committee; and directing them to University wide mentoring programs, developing colloquia and workshops through the CTSI Research Development Group (RDG) to encourage young investigators to pursue careers in clinical research and provide opportunities for collaboration, directing promising clinical researchers into the K12 program and orienting them about the CHS, and providing financial resources through the CTSI Pilot and Feasibility Grant Program.