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The Center for Human Studies (CHS) plays a central role in achieving the CTSI mission and goals by promoting and supporting human studies that bridge novel scientific discoveries to their application in community health care. The CHS places human studies at the hub of our institutional efforts to create a culture of interdisciplinary and translational research. The CHS has a number of unique features and strengths that include:
• One of the largest and most successful GCRC programs in the nation, spanning the diverse urban population of inner city Los Angeles (primary sites at USC Health Sciences Campus and Children’s Hospital Los Angeles), is under transformation to a more highly integrated, expansive program through the Center for Human Studies;
• New, expanded and renovated Clinical Trials Units at USC and CHLA replaces the prior GCRC units and serve as the home base for clinical research for the CTSI;
• Strong institutional support with cost sharing and new clinical research space at USC and CHLA;
• A new focus on off-unit and off-site services that will allow the CHS to bring high-quality human research into our diverse urban community with its unique socioeconomic research participation;
• Close ties to strong CTSI programs in Regulatory Knowledge and Support (RKSP) and in Research Ethics that will partner with the CHS to assure that high quality research is conducted with the highest ethical standards and in full compliance with applicable laws and regulations; and
• New opportunities to develop academic-industry partnerships through the USC Health Research Association.
The aims of the CHS are as follows:
1. Develop mechanisms to promote and support a broad range of clinical research and interdisciplinary studies:
• expand facilities to accommodate greater volume, especially for outpatient testing, in CHS space;
• develop new mechanisms to promote and support studies outside CHS in community settings;
• refining strategies to promote greater participation of underprivileged minorities in clinical research;
• overcome barriers to collaboration between institutions by implementing integrated IRB services and providing videoconferencing and computer interfacing.
2. Develop and expand mechanisms to assure that clinical research is conducted with the highest standards for design, safety, and compliance:
• providing assistance and training in Good Clinical Practice and standards of ethical conduct in research;
• providing comprehensive regulatory support including IND/IDE applications;
• integrating our Quality Assurance and Safety Program to develop common standards and practices across the CTSI;
• assuring robust study design and biostatistical analysis through interactions with CTSI Information Sciences;
• implementing greater informatics support to facilitate clinical trials management.
3. Support new project development and enhance academic-industry relationships in clinical research by:
• establishing integrated Clinical Trials Units (CTUs) to provide greater opportunity to translate important laboratory discoveries, to better support new projects developed by the CTSI Office of Research Development, and to expand relationships with industry;
• harnessing relationships that the USC Health Research Association has developed with industry via quarterly think tank seminars to generate new opportunities for academic-industry partnerships;
• utilizing expertise and industry relations of the USC Stevens Institute for Innovation to facilitate development of novel therapies.
4. Develop approaches to identify, recruit, train, and support new clinical researchers by:
• providing financial resources through the CTSI Pilot Grant Program;
• developing colloquia and workshops through the CTSI Office of Research Development to inform young investigators about careers in clinical research and provide opportunities for collaboration;
• directing promising clinical researchers into the K12 program and orienting them about the CHS;
• screening faculty candidates through the Faculty Research Council and Faculty Appointment Promotion and Tenure Committee, and directing them to university-wide mentoring programs;
• providing comprehensive clinical trials support such as statistical and regulatory consultation, training in GCP, access to study coordinators, and assistance with off-site/off-unit testing.