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Study, Database Design, and Support

Study Design and Biostatistics

Our federated model contains numerous groups with both experience and aptitude in assisting with study design and biostatistical support. Our groups all espouse missions that include educating and working with researchers to help them formulate research questions, develop their study design and protocol, and subsequently participate in study implementation, data analysis and interpretation, manuscript development, and presentation of results. As such, faculty in the Division of Biostatistics often work as integral members of the study team, collaborating with all units on the UTHSC campus including those in the College of Medicine, College of Dentistry, College of Pharmacy, College of Nursing, and College of Health Professions. The Biostatistics, Epidemiology, and Research Design (BERD) unit is available for clinical trials and also provides easily-accessible, free consultations for researchers across all of UTHSC’s campuses in the areas of biostatistics, epidemiology, and research design.

Database Building and Bioinformatics

Medicine is currently undergoing a fundamental ‘information transformation’, spurred in large part by the increasing ability to electronically capture, store and utilize large amounts of clinical data for healthcare research and delivery. For the first time in Tennessee, UTHSC is poised to lead an initiative to establish a statewide electronic data warehouse. This data warehouse will allow researchers to utilize extensive clinical information on patients across the entire state, and will stimulate UTHSC’s participation in large-scale clinical trials across the state.

 The UTHSC Center for Biomedical Informatics (CBMI) is establishing collaborations with UT’s Knoxville, Chattanooga and Nashville campuses to extend its federated enterprise data warehouse model to each of these sites. Once completed, these data warehouses together will contain extensive clinical and outcomes data, including quality of life data, from Tennessee medical centers and communities, enabling comprehensive studies into the effectiveness and long-term outcomes of new cancer therapies. Future versions of these data warehouses will house extensive sensor data (and other types of data) from mobile, household or personal devices. 

By collecting and integrating patient generated data with clinical data from the electronic medical record (EMR), biomedical informatics and database support will be available to all interested researchers throughout the clinical research system. 

Recruitment Support

Our federated system has extensive experience recruiting participants for clinical research studies from the community through advertisement, mass mail, internet recruitment and community screenings. For example, the Department of Preventive Medicine Research Group utilizes a Pitney Bose mass mail printer with the capacity of producing up to 34,000 pieces of mail per week for recruitment purposes, and a telephone computer software system (phone tree) that allows a recorded recruitment message describing a research study to be delivered by phone for recruitment purposes to preprogrammed phone numbers.

Recruitment support will also be available through the Center for Biomedical Informatics, which has integrated its research Enterprise Data Warehouse capabilities in a partnership with TriNetX, in which de-identified data may be made available to researchers on patients within the University’s partner healthcare systems. Using population level data in this way can help investigators determine the feasibility of conducting studies at UTHSC, in their practice, or in a larger system. The system can also allow researchers to identify patients that might meet study eligibility criteria. The functionality of this system allows for better analysis of individual study opportunities, provides information to potential sponsors as to our capabilities to support sponsored research studies, and fosters development of inter and intra-campus networks to fully realize recruitment goals.

Investigator Education

Continuing education and elevation of skills toward excellence in clinical investigation is of primary importance in an academic clinical trials program. As such, UTHSC, through the Department of Preventive Medicine, offers a Master of Science in Epidemiology degree with the purpose of assisting faculty at UTHSC to develop the necessary skills to  become NIH-funded clinical researchers. The Department also offers an online Certificate Program in Clinical Research. The epidemiology graduate program and the certificate program have been integral to the university in providing training that transcends health-science disciplines and produces clinical scientists equipped to conduct clinical and translational research, as well as fostering research and collaboration among local, regional and national entities.

The various clinical research offices have additionally developed short-course format clinical research training for residents, fellows, and junior faculty. One such program is run by the Clinical Research arm of the Children’s Foundation Research Institute, one of our federated members. The course consists of one topic weekly for 10 weeks. Training is broken into units which include:

  • Responsible Conduct of Research (including good clinical practice, intellectual property, research integrity, conflicts of interest, regulatory basics, biological materials, animal studies, and research ethics)
  • Investigator-Initiated Clinical Research
  • Industry Sponsored Clinical Research
  • Regulatory Compliance (including training on institutional review boards, informed consent documents, adverse events recording, and creation and maintenance of regulatory binders)

Medical Writing

Medical writing expertise will be provided through the federated model for clinical research. Medical writers assist investigators and sponsors in a variety of ways, including:

  • Manuscript development, editing, and formatting to ensure compliance with journal specifications
  • Grant development, editing, and formatting to ensure compliance with funder specifications
  • Development of tables and figures for publication using graphics programs
  • Development of templates for poster and oral presentations
  • Generation of publication reports for departments and institutions
  • Reference management using programs such as EndNote
  • Provision of education to researchers and staff on scientific writing
  • Assist researchers in their responses to reviewer comments and critiques
May 26, 2022