Biostatistics Core

Duke University, Durham NC

Investigators

Linked publications, trials & patents

Abstract

The Biostatistics Shared Resource (BSR) provides statistical expertise and collaboration for Duke Cancer Institute (DCI)-member pre-clinical, clinical, translational, data science, and population cancer research. DCI-BSR faculty (9) and staff (14) biostatisticians provide support to researchers in all seven DCI Research Programs. Within Programs, BSR biostatisticians focus on relevant disease and modality groups, allowing each statistician to develop specific areas of statistical expertise and strong, long-term relationships with clinical and laboratory investigators in each CCSG Research Program and across all disease groups. Members seeking initial statistical support can submit requests directly to DCI-Biostatistics via a REDCap survey or via the Biostatistics, Epidemiology, and Research Methods Design (BERD) Core (Duke CTSA UL1TR002553). BSR provides assistance with clinical trial development, compliance, reporting, and oversight. To illustrate, DCIBSR biostatisticians Susan Halabi, PhD, (CRDI) and Lauren Howard, MB, are co-authors on a recent ASCO 2023 abstract: “A prospective trial of apalutamide and abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer,” a trial that addressed potential disparities in treatment. The BSR also participates in and co-leads the development and testing of appropriate systems for trial data management and linkages through Advarra, RedCap, OnCore and other tools. The BSR continues to expand activities in cancer research areas such as Community Outreach, Engagement. One key example is BSR leadership participation (Donna Niedzwiecki, PhD, PCMIT, Samantha Thomas, MB, CRDI) and staff support (Frances Wang, MS) for the Center for Research To Reduce Disparities and Enhance Representation in Cancer through Systematic and Transformative Change (CREST) dashboard development initiative led by Tomi Akinyemiju, PhD (CRDI). The CREST dashboard facilitates evaluation of disparities in the DCI catchment area. The BSR interacts closely with several entities within the DCI, DCI Bioinformatics shared resource, the DCI Information Systems shared resource, the DCI Chief Data Officer, to appropriately meet DCI data and analytic needs. DCI-BSR leadership also engages closely with the the DCI Protocol Review and Monitoring Committee (PRMC) to set and implement policy. Several DCI-BSR faculty members serve on the PRMC as scientific reviewers as well as mentor junior investigators through the Duke Clinical Research Training Program (CRTP). For FY19-FY22, the BSR provided statistical support for a yearly average of 305 data analyses, 65 grant submissions, 10 letters of intent (LOIs), 237 manuscripts, 61 database builds, and 99 clinical trial protocols on an average of 537 activities on studies that were in development, completed, or ongoing per year. In FY22, the BSR provided services to 152 DCI member investigators, representing 100% of usage and all 7 DCI Research Programs. Four hundred and forty-two (442) publications used the BSR over this grant period with 72 papers in journals with impact score of 10 or greater.