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

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

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

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

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

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

Recourses available through CCORDA Center for Collaboration on Research Design and Analysis (CCORDA) http://www.unmc.edu/publichealth/centers/ccorda/index.html Center Director Fang, Yu, PhD Director Of CCORDA and Associate Professor Of Biostatistics Phone: 402-559-9436 fangyu@unmc.edu Center Associate Director Elizabeth, Lyden, M.S. Instructor Phone: 402-559-6061 elyden@unmc.edu

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.

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

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.

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

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

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

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.

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 https://www.unmc.edu/publichealth/centers/ccorda/request.html

Questions?