The focus of the Biostatistics Shared Resource (BSSR) is to collaborate with and provide support to Wake Forest Baptist Comprehensive Cancer Center members by providing analytical expertise and rigor that enhances peer-reviewed research to reduce the incidence of cancer, improve response and survival, reduce morbidity, manage symptoms, improve health-related quality of life and translate important laboratory discoveries into clinical practice.

Goals and Focus Areas

The focus of the BSSR is to collaborate with and provide support to Wake Forest Baptist Comprehensive Cancer Center members by providing analytical expertise and rigor that:

  • Enhance peer-reviewed research to reduce the incidence of cancer.
  • Improve response and survival.
  • Reduce morbidity.
  • Manage symptoms.
  • Improve health-related quality of life.
  • Translate important laboratory discoveries into clinical practice.

The BSSR is responsible for methodological, statistical and analytical issues that may arise during projects. It is also responsible for computational issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews and final analyses.

These responsibilities are encompassed within the BSSR’s four goals:

  • Goal 1: Support investigator-initiated clinical protocol development, including developing appropriate statistical designs, preparing statistical sections, and reviewing the statistical content of protocols submitted for review to the Protocol Review Committee of the Comprehensive Cancer Center.
  • Goal 2: Provide operational and analytical support for clinical protocols, including monitoring patient accrual, providing support for quality assurance efforts, and performing interim and final analyses when needed.
  • Goal 3: Collaborate with Comprehensive Cancer Center investigators from all programs to provide statistical design and data analysis in support of grant development, abstracts, presentations and publications.
  • Goal 4: Provide leadership, education and training in support of the Comprehensive Cancer Center mission, including participation in graduate-level courses, T32-supported training grants, mentoring teams for K awardees and other young investigators, and leadership on committees responsible for scientific and administrative decisions for the Comprehensive Cancer Center, as well as conducting multiple seminar series on topics such as meta-analysis, survival analysis and early-phase adaptive designs for Comprehensive Cancer Center members.

Services We Provide

Clinical Protocol Development

BSSR statisticians provide clinical protocol assistance in the following areas:

  • Specifying study objectives.
  • Defining end points.
  • Selecting appropriate information for data collection.
  • Determining sample sizes necessary to realize study objectives with reasonable power.
  • Assessing study feasibility given the sample size needed and the projected participant pool.

Protocol Monitoring/Analyses

BSSR statisticians conduct the following protocol monitoring and analyses:

  • Perform interim analyses when required by the protocol.
  • Monitor the trial for data quality and safety.
  • Coordinate clinical team meetings to review data integrity and composition to enhance quality control in clinical trials.

Statistical Design and Analyses in Support of Grant Development and Publications

BSSR members support the design of research studies, including basic science grants, as well as the data processing and analysis that follows after the study is completed. This includes:

  • Determination of the experimental design
  • Data generation/collection
  • Data analyses

Three times a year, the BSSR conducts grant planning sessions where potential principal investigators (and research teams) are invited to meet with BSSR statisticians to discuss research designs for upcoming grant submissions.