The Clinical Trials Statistics group at the DCRI represents a blend of both Duke University faculty- and nonfaculty-level statisticians and statistical programmers, including:

• 13 full-time Duke University faculty statisticians
• 37 non-faculty statisticians
• 18 statistical programmers
• 2 part-time faculty-level consultants

The statistics group provides full-service statistical operations for multicenter trials in various therapeutic areas. Each trial is assigned a lead statistician responsible for coordinating the statistical needs of the project, a faculty or senior statistician serving in an advisory and reviewing role, and one or more statistical programmers.

In addition, expanding databases residing at the DCRI provide a rich and sizable resource that can aid development of current assumptions for future clinical trials, as well as answer secondary clinical questions of interest to clients, physicians, and the larger medical community.

Statisticians performing analyses for secondary interests work in close collaboration with physicians and sponsors worldwide to assist in correct interpretation of results. Our analyses are used to produce abstracts and presentations at major medical meetings, as well as publication in the top medical journal articles. No other research organization in the world can match the DCRI’s dedication to disseminating research results that stand up to the most stringent scrutiny.

Faculty Leader: Kerry Lee, PhD
Contact: Kristina Sigmon, Director, Clinical Trials Statistics

Services

• Design of studies and sample-size calculations
• Development of plans for interim analyses and criteria
   for trial discontinuation or modification
• Generation of randomization schemes
• Development of analysis plans, database specifications,
   and mock tables
• Programming and validation of analysis databases
   and statistical tables, figures, listings, and
   advanced statistical analysis
• Production and validation of interim and final trial results
• Coordination of Data and Safety Monitoring Board meetings

Our statistics faculty also conducts methodological research into issues on the cutting edge of biostatistics. Current statistical research interests include randomly repeated measures modeling, meta-analysis, dose-response analysis, multiple testing, correlated categorical data modeling, evaluation of diagnostic tests, and statistical genetics. Faculty contribute as leaders and advisors for trial and manuscript efforts to ensure that the most current and appropriate statistical methods are employed.