Biostatistics and Informatics

• Investigator-initiated, industry-sponsored and multi-center clinical trials
• Experimental design and power/sample size calculations
• Novel trial designs and simulation: fixed and/or adaptive
• Development of randomization schemes
• Prospective Institutional Review Board (IRB)-approved translational trials in a protocol setting
• Retrospective studies (laboratory-based or otherwise) with clinical correlations
• Grant and manuscript preparation

• Experimental design and power/sample size calculations
• Statistical analysis and interpretation
• Data visualization and graphic/figure generation
• Grant and manuscript preparation

• Experimental design and power/sample size calculations
• Array-based platforms (e.g., genotyping, gene expression arrays, DNA methylation, etc.)
• Preprocessing, quality control and analysis of next-generation sequencing data (e.g., RNA-seq, DNA-seq, miRNA-seq, ChIP-seq, 16S rRNA sequencing, etc.)
• Data visualization and pathways analyses
• Access to Ingenuity Pathways Analysis IPA^TM software
• High-performance computing for large ‘omic data sets
• Grant and manuscript preparation

• Experimental design and power/sample size calculations
• Development of randomization schemes
• Statistical analysis, data visualization, and interpretation
• Grant and manuscript preparation

• Case report form building
• CRF Part 11 compliance certified Clinical Trials Management System (called CRIS)
• Data acquisition, governance and engineering
• Custom database creation
• Machine learning and data mining support
• Development of systems for smart patient screening techniques for clinical trials
• Development of visualizations that aid in prioritizing action items for cancer center
• Grant and manuscript preparation

The Accrual Prediction Program provides accrual information, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets for all KU Cancer Center clinical trials. View application, here.

C3OD merges data and allows querying through a single unified platform. By centralizing access and maintaining appropriate controls, C3OD allows researchers to more rapidly obtain detailed information to accelerate eligibility screening. For more information, click here.

OPTIK helps streamline the process of synthesizing data regarding Kansas and Missouri demographics, cancer risk factors, and incidence and mortality rates. OPTIK standardizes these diverse data sources to analyze the cancer burden at local, regional, and national levels while upholding a strict standard of patient privacy. View application, here. 

KU Cancer Center Clinical Trials Finder helps navigate current active clinical trials and helps physicians/clinicians refer patients to an ongoing trial that might help with their treatment. Download the Clinical Trials Finder app for Android and Apple. 

This pilot study was conducted to evaluate the feasibility and effects on risk biomarkers for postmenopausal breast cancer after 6 months of treatment with tissue-selective estrogen complex bazedoxifene and conjugated estrogen (Duavee). The BISR participated in the design and analysis of genomic data collected, which included conducting an unsupervised model-based clustering analysis to cluster participants based on how their expression signatures changed from baseline to post-intervention, along with follow-up analyses aimed at identifying patient-level clinical features that associated with cluster membership.

The results of the study showed significant changes in risk biomarkers for postmenopausal breast cancer, as well as a decrease in reported hot flashes. Learn more.

A clinical study conducted by researchers at The University of Kansas Cancer Center sheds light on the unique challenges African American smokers encounter when trying to quit tobacco. Over the course of a 5-year study, the research team enrolled about 450 socioeconomically disadvantaged African American and white smokers who were interested in quitting. Study results suggested that lower quit rates were not due to race or biological differences in nicotine metabolism; rather, the race difference was explained by socioeconomic factors, such as home ownership, income and neighborhood problems, as well as smoking and treatment process factors. These findings were among the first to illuminate why African American smokers have a harder time quitting smoking, and these learnings can help develop tailored and more effective tobacco cessation treatments. The BISR provided support for the design of this study, statistical analysis and interpretation of study findings. Learn more.

Data used to determine patient eligibility for cancer clinical trials often come from disparate sources typically maintained by different groups within an institution, use differing technologies and are stored in different formats. Collecting data and resolving inconsistencies across sources increase the time it takes to screen eligible patients, potentially delaying study completion. To address these challenges, the BISR at The University of Kansas Cancer Center developed the Curated Cancer Clinical Outcomes Database, also called C3OD. The database merges data from the electronic health record, tumor registry, biospecimen and data registry, and allows querying through a single unified platform. By centralizing access and maintaining appropriate controls, C3OD allows researchers to more rapidly obtain detailed information about each patient, and in doing so, has the potential to accelerate eligibility screening. Some specific examples of use cases of C3OD include: prescreening, projection, retrospective studies, linking to biospecimens and aid preventative health studies. Learn more.