Biostatistics & Study Design

Spectrum provides assistance to investigators for designing clinical trials through the Center for Innovative Study Design (CISD) which is housed in Health Research and Policy.

CISD staff is available to individual investigators pre-award to foster and improve the initial planning and design of studies. Its primary function is to assist investigators in formulating their scientific problems in statistical terms, and to align their experimental design, data collection, and analysis plans with their scientific aims.

The staff also assists with post-award advice on setup of data management, working with the Spectrum Informatics and Operations, Training & Compliance programs.

CISD staff participates in training clinical researchers and their staff in design of studies, statistical analysis, and the use of data visualization and exploration tools.

The operating core of the CISD consists of the HRP biostatistics faculty and academic staff biostatisticians, and key individuals from the faculty of other departments in the School of Medicine and the Statistics Department in the School of Humanities and Sciences.

CISD Grand Aim

In addition to its general collaborative role in research at Stanford, the CISD is oriented toward a transformative ‘grand aim’ – to fully integrate the tools of statistical design into the practice of medicine, helping to advance drug development and create a system of health care that is capable of automatic knowledge-driven improvement at a much faster pace. Besides methodological development toward this aim, the CISD also develops software and computational tools to implement the innovative design and analysis methods developed. It also organizes periodic conferences and short courses to disseminate and discuss recent research findings and developments.

Spectrum, in association with the Department of Health Research and Policy – Center for Innovative Study Design (CISD), offers a free one-hour consultation for help with all aspects of study design, including ethics, biostatistics and data collection.

Discussion topics of interest:

• Statistical design, sample size and power
• Statistical analysis of preliminary data (limited availability)
• Other data management issues (e.g. validation) – data entry services not available
• Advice on analyzing data
• Statistical analysis of data (limited availability)
• Formulating a statistical analysis plan
• Organizing your data for capture into a database
• Statistical support for Data Safety Monitoring Board (limited availability)
• Advice on responding to journal review
• Help in designing a cancer clinical protocol

Prior to your appointment:

• Review Guidelines for Pre-Award Statistical Consultation with SPCTRM (pdf)
• In order to assist you with preparing your data collection tools, see Guidelines for Describing Data as it Relates to Data Collection and Analysis. These codes will help you, and if applicable, your biostatistician when it is time to evaluate/analyze the data. – Data Submission (pdf)
• Example for building your code book/data dictionary – Sample Form (pdf)
• Data collection code book – Variable Information (xls)

The Study Design Workshop (SDW) provides an opportunity for biomedical researchers who are designing a study to meet with members of the biostatistics staff at Stanford and collaboratively develop a research plan.

The researchers typically provide a brief orientation to the problem they are trying to solve and then have a collegial conversation with world class experts on all aspects of study design including sample size, statistical analysis methods and data management. The conversations always center around the idea of how to design the optimal study, which will afford the opportunity to make inferences to the world using as few subjects as possible.

Researchers leave the SDW with well thought through, specific aims and the core methods sections needed for preparing grants and conducting a successful research project.

The SDW forms long term teams to assure that biostatisticians can see a study through to its completion.

The CISD was created in March 2009 to integrate efforts that had been dispersed in the School of Medicine, including the:

• Biostatistics Data Coordinating Center (providing design and implementation of specialized, innovative clinical study data management and visualization tools)
• Biostatistics Shared Resource of the Stanford Cancer Center
• Spectrum Biostatistics and Design Program
• design and review capacity of the Clinical and Translational Research Unit (CTRU)
• clinical and translational research (CTR) offerings in pre-award design consultation service

Study design consultation services are provided through the Center for Innovative Study Design (CISD), which is housed in Health Research & Policy.

All biostatistics/study design consultations are scheduled through Study Navigator.

Center for Innovative Study Design
Dept. of Health Research and Policy
HRP Redwood Building
Stanford University
Stanford CA 94305-5405

Fax: (650) 725-6951

Support: Brit Turnbull, Biostatistician
Phone: (650) 725-4345
Email:

» Health Research & Policy website

» Division of Biostatistics website