1. Biostatistics Resources for Clinical and Translational Research
Fang Yu, Ph.D.
Director of CCORDA
Associate Professor of Biostatistics, UNMC
Director of Clinical Research Design, Epidemiology and Biostatistics, GP IDeA-CTR Network

2. Overview What biostatisticians can (and cannot) do for you
Center for Collaboration on Research Design and Analysis (CCORDA)
Role of CCORDA in the Great Plains IDeA-CTR Network
CCORDA services
When to Contact CCORDA

5. Why and when to work with a biostatistician?
Planning the study
Writing specific aims/hypotheses
Experimental design, randomization, sample size, IRB
Grant writing
- Statistical considerations, sample size justification
Conducting the study
Data collection methods, interim analyses, DSMB

6. Why and when to work with a biostatistician?
Database
- variables collected, data checking and cleaning
Reporting and interpreting results
- data analysis, manuscript preparation, presentations

7. Complex analysis issues
Notes:
Correlated values - multiple measurements on same subject Clustering
Missing data and drop outs
High-dimensionsal data microarrays, proteomics
Multiple comparisons

8. What we can’t do
Fix a poorly designed study Make the result significant (p-value < 0.05, data snooping) Reveal interim results for data under purview of a DSMC Compensate for poorly collected data or variables that were not collected

10. Recourses available through CCORDA
Center for Collaboration on Research Design and Analysis (CCORDA) Center Director Fang, Yu, PhD Director Of CCORDA and Associate Professor Of Biostatistics Phone: Center Associate Director Elizabeth, Lyden, M.S. Instructor Phone:

11. CCORDA
Coordinate services provided by faculty and staff in the College of Public Health
Make resources more easily accessible to investigators
Faculty and staff of the College of Public Health will become an integral part of the research team.

12. Research Areas
Former Statistical Center for the Children’s Oncology group
Biostatistics Shared Resource of the (NCI-designated) UNMC Fred & Pamela Buffett Cancer Center
Core for pancreatic cancer SPORE
Biostatistics core for Boys Town
National Research Hospital

13. Role of CCORDA in the Great Plains IDeA-CTR Network
Serve as Clinical Research Design, Epidemiology and Biostatistics Core
Our objective is to develop the infrastructure to conduct high-quality CTR and enhance development of competitive
CTR programs and
research teams across
Great Plains.

14. CCORDA services to CTR Research Design Design Consultation for:
Laboratory based studies
Experiments producing high-dimensional ‘omic’ data
Clinical trials
Clinical epidemiologic studies
Genetic epidemiology studies
Multi-center studies
Community and population-based epidemiology studies
Secondary analysis of complex survey data
Qualitative studies, Mixed methods studies
Systematic review studies
Sample size calculations
Randomization sequences
Recruitment plan development
Statistical analysis plan development
Protocol and grant development
Protocol coordination

15. CCORDA Services to CTR Data Acquisition and Management Data management
Data and safety monitoring
Data query reports
Develop, monitor and manage study databases
Data linkage
Develop web-based surveys
Develop case report forms
Develop web-based data entry programs
Program scannable case report forms
Instrument validity and reliability
Conduct systematic review
Perform complex data acquisition, merging and processing

16. CCORDA Services to CTR Analysis and Reporting
Analyze and develop a report on:
Experiments producing high-dimensional ‘omic’ data (i.e. Affymetrics/Illumina Microarray, Next-Generation Sequencing (NGS), Proteomics, Methylation)
RT-PCR data
Genome Wide Association (GWAS) data and candidate gene/SNP data
Clinical study data
Community- and population-based epidemiology data
Complex survey data
Qualitative research data
Mixed methods research data
Systematic review data (including meta analysis)
Manuscript writing

17. When to contact the CCORDA
When you need expertise in these areas
The expertise and knowledge of the CCORDA members can supplement your area of expertise and enhance the quality, integrity and validity of your study or project.

18. Online Requests for Services
Indicate important time deadlines (abstracts etc.)
Reason for deadline:
□grant submission □ IDEA-CTR Project □ abstract
□ presentation □ manuscript □ other
Project title:
Type of support requested:
□Research Design/Development
□Database development
□Data Acquisition and Management
□Clinical research ethics
□Data Analysis/Statistical Support
□ Research with underserved populations □ Community-Based Participatory Research
Brief goals and description of the project

19. Questions?