CORE--BIOSTATISTICS FACILITY

Wake Forest University, Winston Salem NC

Investigators

Linked publications & trials

Abstract

The primary goal of the Biostatistics Core is to facilitate the peer- reviewed research of Cancer Center members. We are responsible for collaborating with clinical, cancer control, and basic science investigators throughout all phases of cancer-related research projects designed to reduce the incidence of cancer, increase treatment options, improve response and survival, reduce morbidity, manage symptoms, improve health-related quality of life, and move3 important laboratory discoveries into clinical practice. Major responsibilities are assumed for methodological, statistical, and computer related issues including study design, computer networking, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. Specifically, we are responsible for 1) ensuring that study designs are adequate, 2) writing the statistical sections for all treatment protocols, including plans for interim monitoring of trial results, 3) developing randomizing schemes for phase III clinical trials, 4) assisting with the development of sample survey instruments, 4) developing sampling plans, 5) monitoring ongoing protocol accrual, 6) providing methodologic support to CCWFU investigators, 7) perform interim data analysis, 8) performing ad hoc and final analyses, 9) collaborating in interpreting and publishing results, and 10) participating in CCCWFU committees responsible for the scientific and administrative direction of the CCCWFU. Each year, on average, statisticians in the Biostatistics Core worked with 55 different investigators from 16 departments or sections. Statistical sections were written or modified for 15 clinical protocols and assistance were provided for 19 grant submissions, 26 manuscripts, and 9 abstracts. Overall, 65% of the biostatistical effort was for externally peer reviewed funded projects. Statistical analyses and programming account for the majority of work (39% and 38%, respectively). Protocol and grant member accounted for 8% of the effort, biostatistical research 8%, and administration and development activities the remaining 7%. During the coming grant period, we are requesting 1.5 FTEs of statistical support and 0.25 FTEs of programming support to provide these services to Cancer Center members. This is approximately 40% of the total support of the Core.