The Duke CFAR Clinical Core provides support to Duke CFAR investigators in the areas of design, implementation, analysis of clinical trials and dissemination of clinical trial results.  In addition, the Core provides a critical link between laboratory investigators and clinical material, whether that be in the form of access to patients, archived clinical materials or clinical investigators with necessary expertise.   Specific areas of expertise and support include:

 

 

         The Duke Leadership and Core members will review study proposals and

         Provide guidance into optimal study design, logistacal issues with implementation,

         and suggestions for data collection and analysis.

 

 

         The Clinical Core coordinator will help with the preparation of initial regulatory

         submissions, yearly continuing reviews, study amendments and in filing severe

         adverse event reports to the Duke IRB.

 

 

         Dr. Cunningham and the Clinical coordinator will work with you to facilitate the

         development and submission of applications to NIH-funded networks to request

         repository samples for translational research.

 

 

        After reviewing your grant application, out highly experienced and dedicated investigators

        will provide you with suggestions for potential sources of funding that may be appropriate

        for your study.

 

 

        Once the grant is approved and you have secured regulatory documents and approvals,

        we will assist you to develop and implement novel recruitment strategies to facilitate

        recruitment into investigator-initiated clinical trials.  We do have an existing patient

        database with detailed medical information regarding both the Duke Pediatric and Adult

        HIV clinics.  These may be helpful in identifying patients for your study.

 

 

        The Clinical Core can provide critical assistance in the analysis of study results.  If you

        have data from a study and need assistance in the clinical and/or statistical analysis of

        your data, a meeting will be arranged with the Clinical Core investigators and the

        Biostatistical Core to assist with data analysis and interpretation.  The CFAR investigators

        will also assist you in preparation of the manuscript.  We can also provide you help with

        identifying appropriate journals for submission of your manuscript and presenting your

        data to the clinical audience.

 

 

Please see Getting Help for information on how to access Clinical Core services.