The Biostatistics, Epidemiology and Research Design (BERD) key function provides support in the areas of biostatistics, epidemiology and research design to CCTS researchers. Services include consultations on study design for clinical trials, community-based participatory research, and population-based (epidemiologic) studies, and quantitative data analysis. These services are provided to support pilot studies, grant submissions, and publications. In addition, BERD members review protocols; the optimal time to seek input on a protocol is before it is submitted to the CCTS for a formal review.
Study design consultations occur at the initial stage of study planning, preferably before IRB submission. Design issues vary by study type (clinical trial, community-based participatory research, healthcare big data or population-based study). Potential topics for consultation include:
- statistical analysis plan
- endpoint determination
- randomization schedules and implementation
- identification of population risk sets and exposures
- protocol review
- sample size considerations and calculations
- eligibility criteria for prospective studies and healthcare big data
- conversion of research data management to analysis datasets
- pilot study planning and letter of intent (LOI) development
- development of extramural grant application
Data analysis consultations occur throughout the project from initial planning to dissemination. Support is available for most quantitative data analysis methods. In addition, the BERD is available to support dissemination of findings by creating effective graphical summaries of project data. To support data management and stakeholder communication, summary reports and executive summaries can be produced at regular, predetermined intervals. Final materials (e.g. analysis plans, tables and figures, analytical write-ups) will be provided based on timelines and goals established at initial consultations. Research within team science is an iterative and ongoing process, so materials will be stored and maintained through project completion. Support for secondary data analysis is available within the areas of clinical interest for each BERD member.