Services of the Division of Biostatistics and Bioinformatics

Services Provided by the Division of Biostatistics and Bioinformatics at National Jewish Medical and Research Center in support of Clinical and Pre-Clinical Studies.

Study Services
Data Processing and Analysis Services
Training

Study Services:

• Training of Research and Operational Staff in the Functioning of the Study

• Study Design

  • Structure—e.g., Clinical Trials, Phase I, II, III and IV designs; Pharmacokenetic/dynamic designs; Post-Marketing, Adverse Event and Pharmacoepidemiology designs
  • Sample Size and Power
  • Randomization Schemes including Web-based
  • Protocol explanations for Institutional Review Boards
  • Structures to improve subject compliance

• Study Management

  • Provide staff for independent Data and Safety Monitoring Boards
  • Develop research plans and conduct independent interim statistical analyses
  • Compliance reports for clinical centers

• Data Management

  • Provide Web, Fax, electronic (PDF), scanned and manual entry
  • Data capture, storage and sharing procedures in compliance with federal regulations regarding the integrity and confidentiality of patient data
  • Develop appropriate database structures and reporting schemes
  • Provide ongoing data quality monitoring and analysis

• Data Analysis

  • Development and execution of standard analysis schemes to determine significant differences and influential variables including:
    • Repeated Measures Analysis of Variance to compare baseline to later study time results both between and within subjects and groups—application of mixed-model procedures
    • Analysis of Trends and Time Series
    • Data Imputation to adjust for missing values
    • Microarray and proteomics analysis

• Utilization Analysis

  • Analysis of the factors influencing effective utilization
    • Examination of cluster and nested effects that produce differences in such factors as clinics, clinicians, plans, clients, or patients

• Economic Analysis

  • Cost and cost/benefit analysis using standard clinical and quality of life measurement
  • Development of prediction models that cansuggest how appropriate utilization can result in cost savings
    • Conducting studies to verify the effectiveness of these predictions

• Presentation

  • Present and interpret results for Data and Safety Monitoring Boards or Scientific Advisory Boards
  • Graphs, tables, and reports tailored to the audience and linked to examples using individual patient profiles
  • Writing of final reports or papers and providing appropriate presentation materials

Data Processing and Analysis Services

Provide statistically and clinically meaningful reports of the following types of analyses:

1. Comparing outcome changes between baseline and predetermined intervals from one patient group to another. Groups can be divided by provider type, co-morbid state, demographic information, socioeconomic information, etc.
2. Trend Analysis: Evaluation of trends within the same patient groups at predetermined intervals.
3. Time-series Analysis: This sophisticated technique allows data sets to be analyzed to determine if seasonal or other time factors affect results.
4. Cluster Analysis: Some patients are clustered within certain groupings, such as physicians, clinics, plans, or clients. Some statistical techniques (like a random-effects mixed model) can test for significant differences between these clusters.
5. Regression models to identify risk factors of high utilization. This technique would analyze factors that can become predictors of certain outcomes.
6. Quality Control/Quality Assurance schemes can vary from simple range checking on data entry to cross-variable validation and re-randomized sub-sample comparisons.

Training

In addition to the above support for investigator protocols, staff personnel provide classes in basic statistics and the use of SAS and JMP-SAS for clinical and basic science investigators. Core faculty also teach graduate level statistics courses at the University of Colorado at Denver and Health Sciences Center, Department of Preventive Medicine. The Division of Biostatistics and Bioinformatics maintains a web page on the National Jewish Intranet with useful statistical information, links to obtain additional information, and a list serve for questions about SAS or JMP-SAS. Core members also assist in training fellows and in serving as advisors for investigators, fellows or Ph.D. candidates who take advance training in quantitative aspects of medicine, biostatistics, or epidemiology.

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