The Clinical Core services fall into 5 broad categories:
Consultation on study design, implementation, analysis and manuscript preparation
Drs. Cunningham and Bartlett are highly experienced clinical investigators, and their experience offers a great service to laboratory-based investigators and junior investigators who need human subjects for their research. They average 20 consultations on studies per year. These consultations may provide input on study design, study interventions, study outcome measures, appropriate subject populations, project implementation, adverse events, study analysis, interpretation of results, and publication of manuscripts.
Clinical Research Support
The Clinical Core can assist with a number of issues related to the conduct of specific research studies. This may include consultations on study design, study feasibility and recruitment and retention issues. In addition, study coordinator assistance may be available for some studies. Salary support is requested for study coordinator assistance whenever possible. Stuart Carr has been working with various study teams on these issues for a number of years.
Regulatory compliance is essential by all Duke CFAR investigators, and the Clinical Core provides expertise and assistance in ensuring compliance. Regulatory support is the service most commonly requested by Clinical Core Users, and approximately 100 users access this service annually. Given the number of international studies and the number of countries in which CFAR investigators are engaged in research, the management of regulatory compliance has become enormously complex. The CFAR Clinical Core can assist international partners with requirements for DUHS IRB submissions, human subject protection training, and other specific requirements related to their research. Stuart Carr and Kathy Link have many years of regulatory experience working with various types of studies in the United States and internationally.
Database and Biorepository Access
The Clinical Core has established a database and biorepository. This Database includes nearly 1900 HIV-infected persons receiving care in the Duke University Adult Infectious Diseases Clinic and will soon include approximately 100 HIV-infected children and adolescents receiving care in the Pediatric Infectious Diseases Clinic. The demographics of these patient populations mirror the reported demographics for North Carolina (57% African American and 28% women). There are currently over 70,000 plasma samples in this biorepository.
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The Clinical Core supports Community Advisory Boards (CABs) in Durham, North Carolina and in Moshi, Tanzania. The CABs provide CFAR investigators with an important opportunity to interact with the community and receive feedback on study proposals and to disseminate research results back to the community. The Durham CAB meets every two months. The Moshi CAB meets monthly, and it has separate meetings for a Youth CAB. These CABs have been active within the National CFAR CAB Coalition, attending meetings in Philadelphia, Seattle and Boston and participate on conference calls. Julieta Giner is the Durham CAB liaison. Bona Shirima is the Moshi CAB liaison. Both have many years of experience working with the HIV- infected and HIV-affected communities.