The design and analysis of a wide variety of oncology clinical trials constitutes the majority of our work. Trials range from Phase I single or multi -institution industry sponsored to Phase III multi-institutional cooperative group trials. Some clients request only a subset of our clinical trial statistical services.
Among these are:
- Design of clinical trials, including selection of most appropriate endpoints and, sample size and power calculations
- Development of Statistical Analysis Plans (SAPs)
- Perform interim analyses
- Write DSMC reports and participate on DSMCs
- Serve as Independent Statisticians to support DSMC
- Develop and maintain web-based reports on protocol status, survival endpoints, response and toxicities
- Analyze clinical and correlative data for peer-reviewed manuscripts, scientific abstract submissions and presentations
- Prepare materials for and participate in FDA meetings
Our biostatisticians provide other cancer related services including the
- analysis of high-dimensional data such as gene expression and SNP data to identify reproducible genetic markers
- cancer staging projects
- collections and analysis of data on cancer outcomes
Finally, CRAB statisticians are involved with cutting edge methodological research on novel clinical trial designs.
CRAB is a member of the Clinical Data Interchange Standards Consortium (CDISC), an international, non-profit organization that develops and supports global data standards for medical research. We support and implement CDISC standards as appropriate in the conduct of research.