Biostatistics faculty and staff serving on the BISR have a variety of research interests and expertise, including: SEER/Medicare data, mixed models, survival analysis, clinical trial conduct/monitoring, prediction modeling, tumor registry, Bayesian methods, missing data, and longitudinal data analysis.   They provide collaborative support on study design / trial design, data quality control, statistical analysis, interpretation of results, data coordinating, power and sample size, and DSMB/regulatory reporting.   Educational support is also provided through workshops and statistical training, VELOS eResearch training, and mentors/co-mentors for students/junior faculty research projects.

The BISR supports data management, study design and statistical analysis of phase I, phase II and phase I/II clinical trials conducted by University of Kansas Cancer Center Members. 

To support trial design, we have developed an electronic Case Report From (eCRF) Content Toolkit that is flexible and not system dependent.  The fields were developed using Clinical Data Acquisition Standards Harmonization (CDASH) standards published by the Clinical Data Interchange Standards Consortium (CDISC) when available and inter-disciplinary collaboration with the University of Kansas Cancer Center when CDASH standards were not available.  Researchers use the tool to design study eCRFs by selecting the fields they want included, indicating whether they are mandatory or optional, and dictating the order of presentation.  Should the study require a modified field to achieve study objectives, a new field or variable will be added to the repository of variables in the Content Toolkit. To get a copy of the current toolkit, please contact Dr. Byron Gajewski (bgajewski@kumc.edu).

In addition to creating the eCRF toolkit, the BISR has developed workflows/diagrams which illustrate the BISR role in clinical trials and the process for eCRF development.

The Informatics faculty and staff serving on the BISR provide expertise in data and specimen collection systems and software tools used in cancer research.  Services provided are hospital billing data collection, regulatory data reporting, research database management, data collection training, and integration of third-party software/tools. 

Three major initiatives in the BISR Informatics group have been

• The development of a biospecimens database for the tracking of samples collected and stored in the Biospecimens Shared Resource.
• The development of the Curated Cancer Clinical Outcomes Database (C³OD), which pulls electronic data from EMR and combines it with manually abstracted data, prospectively collected data, and Clinical Trial Collected data.  The end result is a repository of curated cancer outcomes data that can then be used in future research endeavors.
  • C30D - Curated Cancer Clinical Outcomes Database
• The development and use of standardized electronic case report forms (eCRFs) across all Cancer Center studies.  This has been done by the development of the eCRF Content Toolkit with provides standardized data field content selection options to researchers starting new studies. Click here for a recorded eCRF Development Process Presentation.

The Bioinformatics faculty and staff serving on the BISR provide support to researchers both within and outside KUMC on both grant-funded and chargeback-based projects for management and analysis of large-scale molecular datasets produced by high-throughput technologies, such as microarray or next-generation sequencing, including managing, visualizing, analyzing, and interpreting high-dimensional 'omic data produced from human or model organisms.  The BISR has partnered with the KUMC K-INBRE Bioinformatics Core, directed by Dr. Devin Koestler, to provide researchers with access to  Ingenuity Pathway Analysis (IPA) software and high performance computing (HPC) at KU-Lawrence.  This partnership provides a large community cluster, a 20-fold increase in processing power, capability of supporting over 24,000 processing cores, and 60-80 TB of storage for research projects supported by BISR/K-INBRE.  

If the biostatistics, informatics or bioinformatics faculty and staff had substantial participation in the study design, analysis or interpretation of data, along with drafting portion of the manuscript, they will be included as a Co-Author on the manuscript. They will also be given the opportunity to review the final manuscript for approval prior to submission. This is in adherence to the guidelines set out by the International Committee of Medical Journal Editors (http://www.icmje.org).

All manuscripts using the Bioinformatics Core service need to include the following statement in the acknowledgement section of the paper.

"Statistical, informatics and bioinformatics related analyses presented in this manuscript were performed by the Biostatistics and Informatics Shared Resource that is supported in part by the National Cancer Institute Cancer Center Shared Grant award P30 CA168524."

User Agreement of use of IPA

The strongest grant proposals are those in which the proposal team is assembled at least two-four months before submission. Holding team meetings every three weeks or more often and having at least two major revisions of the proposal are optimal. When bioinformatics faculty or statistics faculty have sufficient time to do their best jobs, the likelihood of funding is significantly enhanced.

With rare exception, we cannot provide assistance with proposals without a minimum of 1 month advance notice. As the core faculty and staff are working on multiple projects, grant applications and teaching courses for KUMC at a given time, sufficient notice is needed to allocate the time needed for grant preparation. This includes time for meetings with the faculty member working on the grant preparation to go over the aims of the grant, study design, budgeting and any questions that might arise with the grant. It is also expected that the faculty member working on the grant will also be including on the grant with the appropriate FTE as either a Co-Investigator or Statistician.

The core does not allow an investigator to use the name of a Ph.D. or M.S. bioinformaticians or biostatisticians on a grant or contract proposal unless they have fully participated in the development of the proposal and can vouch for the study design, analysis workflows and analysis plan.