Biostatistical Projects

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, cooperative group SWOG trials, as well as industry-sponsored trials (see Key Partnerships).

In addition to designing and analyzing trials, CRAB biostatisticians are involved with cutting-edge methodological research on novel clinical trial designs and have led or contributed to many publications in that area. The third edition of The Handbook of Statistics in Clinical Oncology, edited by Drs Crowley and Hoering, and the third edition of Clinical Trials in Oncology, Green, Benedetti, Smith and Crowley, both are scheduled for publication in the spring of 2012. More information about our contributions to clinical trials and biostatisitics can be found in our CVs under the Biostatisticians and Other Publications sections.

There are a number of projects our biostatisticians conduct beyond what normally occur in clinical trials.

Staging
Our first staging project was done for Myeloma. Building on that expertise we provided data gathering (over 100,000 retrospective cases, world-wide) and statistical services for the 7th Revision of the Lung Staging funded by Eli Lilly and under the leadership of International Association for the Study of Lung Cancer (IASLC). Contracted again by IASLC we are currently working on the 8th revision for lung, mesothelioma and thymic cancers.

Genetic Predictors
CRAB is the Statistics Core for the P01 grant for the Myeloma Institute for Research and Therapy (MIRT) housed at the University of Arkansas Medical Center (UAMS). CRAB responsibilities include the design of all clinical trials performed at MIRT, as well as the analysis and reporting of studies in peer-reviewed journals.

MIRT has tracked gene expression and SNP data before, during and after treatment. This has afforded us the opportunity to develop methodology and analytic skills for high-dimensional genomic data. Together with our collaborators at MIRT we have developed a valid and reliable 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.

In the past ten years, myeloma has gone from being a deadly cancer to becoming a manageable chronic disease. The word cure is even being used thanks to the diagnostic advances and treatments we have studied with our colleagues at MIRT.

Historical Controls
Phase II trials classically are single arm designs. We have conducted historical control projects for lung, pancreatic and myeloma cancers providing benchmarks for standard treatment.

  • We have analyzed 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. Both projects have been under the auspices of the International Myeloma Foundation.
  • The lung and pancreatic historical control projects have the same intent and have been funded by the National Cancer Institute.