What Makes The VCRC Unique? h1 >
The VCRC Repository
At each study visit, multiple biological specimens are collected and are banked for future research: plasma (EDTA and citrate), serum, and urine. Whole blood is collected for genomic DNA, and RNA is collected in a number of clinical trials. Aliquots are stored in barcode-labeled vials, and barcodes allow linkage to the clinical data stored at the DMCC.
The VCRC Biomarker, Genetics, and Clinical Research Program
One of the major goals of the VCRC is to use the specimen repository and clinical data to discover better biomarkers of disease activity, organ damage, and prognosis including risk of disease flare. Multiple projects have been initiated in collaboration with laboratories around the world. Ideas for projects have been initiated by VCRC investigators or non-VCRC-affiliated scientists, and brief project proposals are submitted to and reviewed by the Steering Committee. The VCRC also serves as a valuable resource for genetics studies, proposals for which are reviewed in the same manner.
The VCRC-VF Fellowship Program
The VCRC-VF Fellowship is a mentored training program of up to two years for physician-investigators who have a strong interest in vasculitis and wish to pursue a period of specialized training with an emphasis on clinical and/or translational patient-oriented clinical investigation. The trainee will undertake the Fellowship at a VCRC-affiliated site in North America that has an established distinct clinical and research program in vasculitis and availability of senior faculty mentors.
What is the DMCC and what resources does it have?
The DMCC provides coordination for the RDN by organizing meetings and conference calls, supporting Network committees and providing tools to disseminate information to the public and the larger community of health care providers about rare diseases. Among the tools and functionality provided is a public website that contains information about each consortium and a contact registry where individuals self-register for information about studies in which they might want to participate.
The public website is also a portal to the password protected website where we have consortium specific folders, calendars and protocols. It is a place where both network wide materials are posted along with materials that are consortium specific. Protocol or study specific tools available on the members page include the ability to 1) register and/or randomize subjects, 2) enter data on electronic case report forms, 3) report/manage and review adverse events, 4) upload or view laboratory and image data, 5) maintain a log of sample shipments to reference laboratories, 6) monitor study progress and view progress reports, 7) view consortium authored videos and 8) conduct web-based video conferences.
What statistical support does the VCRC have/provide?
The VCRC has access to biostatistical and informatics support to assist it in the design, conduct and analysis of epidemiological studies and clinical trials. Issues related to alternative study designs, sample size calculations and univariate and multivariate analyses are within the scope of the VCRC biostatistical core. As well, the group can assist investigators with regulatory issues for both US and foreign sites. Typically data systems and reporting meet GCP and ICH requirements and the biostatistical core has work effectively with both NIH/FDA and industry supported trials.