CRAB’s biostatistical team encompasses a wide variety of backgrounds and expertise with decades of experience in the field of oncology clinical trials. Several statisticians have affiliate appointments at the Fred Hutchinson Cancer Research Center and the Biostatistics Department at the University of Washington.
We have experience in the design and analysis of a wide variety of oncology clinical trials with associated translational data. Trials include single-institution oncology trials, co-operative group SWOG trials as well as industry sponsored trials. In addition to designing and analyzing trials, CRAB statisticians are involved with cutting-edge methodological research on novel clinical trial designs and have led or contributed to many publications in that area.
Some of our recent projects and associated expertise include the following:
We are in the 8th revision of the International Association for the Study of Lung Cancer, staging project.
- Retrospective and prospective data collection analysis for new revision of 100,000 lung cancer cases world-wide
- Mesothelioma and thymic cancers to be included in the 8th revision for first time.
We are the Statistics Core for the P01 grant housed at the University of Arkansas Medical Center (UAMS). Responsibilities with regard to this grant include:
- Design all clinical trials performed at the Myeloma Institute for Research and Therapy (MIRT).
- Write DSMB reports.
- Perform Interim Analyses.
- Maintain webpage with approximately 1400 reports on protocol status, including survival endpoints, response and toxicities, updated weekly.
- Analyze clinical and correlative data for peer-reviewed manuscripts, scientific abstract submissions and presentations.
We have long-standing experience in the Analysis of High-Dimensional data, such as Gene Expression data and SNP data included in the UAMS P01 project. Together with our collaborators at the UAMS we have developed a risk score based on the gene expression of 70 genes. This risk score has proven to be the most predictive indicator of the outcome of a Myeloma patient and has led to the formation of a new company that makes this gene signature available to every clinic.
We have a variety of statistical consulting contracts in place with several individual pharmaceutical companies. Services include:
- Consulting in the Design of Clinical Trials, including endpoint selection, most appropriate trial design, sample size and power calculation.
- Writing statistical analysis plans (SAPs)
- Accompany companies as Biostastistics Representative to type B meetings at the FDA.
We are the statistics core for the Stand Up to Cancer Pancreatic Dream Team. Services included are similar to the ones reported above.
Drs. Crowley and Hoering have edited the third edition of the Handbook of Statistics in Clinical Oncology which is due to be published in early 2012. This third edition expands on the first and second edition as a compilation of statistical topics relevant to cancer research in general and to oncology clinical trials and translational research in particular. Since the last edition, published in 2006, many new challenges have arisen in this area and the current addition has added new chapters specifically addressing areas of trial design issues pertaining to targeted trials, adaptive trials, analysis of high-dimensional data and imaging techniques. In addition, previous sections of the second edition have been revised to reflect the current state of the art.
Clinical Trials in Oncology has been fully revised and this third edition is ready for publication in 2012.
We collaborate on several projects with the International Myeloma Foundation. We analyze retrospective historical control data of Myeloma patients relapsing on Immunomodulatory agents (IMiDs). We are also updating long-term follow-up on patients treated on a variety of trials world-wide.