Overview

The Biostatistics Shared Resource collaborates on clinical, translational, and scientific research within the Duke Cancer Institute to study conception and design, grant writing and protocol development,  statistical analysis plan creation and implementation, participation in the DSMP, case report form and electronic data capture database design, data manipulation and statistical analysis for manuscripts, abstracts, and presentations, and other critical research activities.

These efforts are aligned with the DCI disease groups and centers, with teams of faculty and staff biostatisticians collaborating across all areas of research within DCI. This includes participating in research developmental meetings and providing research methodological leadership in support of DCI’s scientific initiatives. These alignments have resulted in strengthened grant funding, an increase in high-impact publications, and an enhanced research-training environment at DCI.

Services

• Access to state-of-the-art expertise in biostatistics methods for study design, analysis, and reporting.
• Partnerships in disease-specific clusters and centers with embedded biostatistics teams providing ongoing development of research, grant applications, and clinical protocols.
• Participation and co-leadership in the development and testing of appropriate systems for trial data management and linkages through Advarra, REDCap, and other tools.
• Assistance with compliance of clinical protocols through the support of clinicaltrials.gov reporting, preparation of DSMB summaries, and participation in the DSMC meetings. Scientific review of all DCI protocols, service on the Protocol Review and Monitoring Committee, and the Safety Oversight Committee.

Technologies

The Biostatistics Shared Resource members have numerous types of statistical computing software available for the analytic needs of the DCI. These include but are not limited to SAS, R, Stata, nQuery, PASS, MPlus, , Matlab, Maple, and Mathematica. Most are available through University-based site licensing or through departmental group licenses.

Equipment

Most of the Biostatistics Shared Resource efforts are dependent upon computing and associated infrastructure. The computing hardware infrastructure of the Biostatistics Shared Resource comprises dedicated hardware owned by the Biostatistics Shared Resource and managed and maintained by the Duke University Office of Academic Solutions and Information Systems (OASIS). Additional computing resources are also available through collaboration with the DCI Bioinformatics shared resource, DCI Information Systems), Duke University Office of Information Technology, and the Duke Clinical and Translational Science Institute.

Accessing the Biostatistics Shared Resource

The DCI Biostatistics Shared Resource is available for collaboration on DCI member-led research projects. Collaboration prioritization is based on study funding availability, which may come from sponsors, grants, or departmental funds, and on DCI’s scientific initiatives and goals. Collaboration on trainee projects is considered as long as the trainee’s mentor is a DCI member and funding is available to support the statistical effort. Collaboration on unfunded projects is considered for non-trainee projects that have no other funding availability. Unfunded projects are prioritized based on future grant application planning, DCI initiatives, and available statistician effort.

Collaboration requests can be submitted directly to the DCI-Biostatistics Shared Resource by completing the DCI-Biostatistics Collaboration Request Form 

Biostatistics faculty and staff regularly participate in the disease group research meetings, according to their assigned alignments. This enables the Biostatistics faculty and staff to remain aware of research priorities, allows participation in discussion of research directions, and allows for the appropriate planning regarding protocols, grants, manuscripts, and projects.

For new or underdeveloped research directions that are not sufficiently supported, DCI-Biostatistics leadership arranges and participates in meetings to discuss needs and appropriate staffing for the research area. DCI-Biostatistics leadership then determines required resources and personnel to ensure that the needs are met. This process may require DCI Administrative leadership review and approval for necessary resources such as hiring of additional biostatisticians.

Additional Resources

• Clinical Trial Design Systems Operations Manual (PDF, 142 KB)

Contacts

Director
Donna Niedzwiecki, Ph.D.

Manager
Samantha Thomas, MS
919-668-5892

Core Location
Hock Plaza, 8th floor, 2424 Erwin Rd., Durham, NC