Services > Biostatistical Projects
Experience. CRAB’s biostatistical team encompasses a wide variety of backgrounds and areas of expertise with decades of oncology experience. Several of our senior-level biostatisticians have affiliate appointments at the Fred Hutchinson Research Center, the Biostatistics Department at the University of Washington, and the Oregon Health and Science University.
Our clinical trial experience includes the design and analysis of single- and multi-institution trials and cooperative group SWOG trials, as well as Industry-sponsored trials for new drug registrations. (see Collaborations).
Research. In addition to design and support of clinical trials, CRAB biostatisticians have generated cutting-edge methodological research on clinical trial designs that have led to many peer-reviewed publications.
The third Edition of the Handbook of Statistics in Clinical Oncology, edited by John Crowley (CRAB Founder) and Antje Hoering (CRAB CEO), was published in Spring 2012. In addition, John Crowley along with Shigeyuki Matsui edited a forthcoming volume titled Frontiers of Biostatistical Methods and Applications in Clinical Oncology which includes biostatistical articles on novel methods in oncology. More information about our contributions to clinical trials and biostatistics can be found in our CVs under the Biostatisticians and Other Publications sections.
Our first staging project was the development of the International Staging System for Myeloma. Building on that expertise we provided data gathering (over 200,000 retrospective cases, world-wide) and statistical services for the 7th and 8th editions of the stage classification for lung cancer, under the leadership of International Association for the Study of Lung Cancer (IASLC). Contracted again by IASLC we are currently working on the 9th edition for lung, as well as for mesothelioma and thymic cancers. The 9th edition will also incorporate biomarker and treatment data into the analyses.
CRAB has collaborated with the University of Arkansas for Medical Sciences Myeloma Center, for over 20 years. CRAB designed clinical trials performed at Myeloma Center, as well as performed the analysis and reporting of studies in peer-reviewed journals.
The Myeloma Center has for many years tracked gene expression data before, during and after treatment. This has afforded CRAB biostatisticians the opportunity to develop methodology and analytic skills for high-dimensional genomic data. Together with our collaborators at the Myeloma Center we developed a valid and reliable risk score based on the expression levels of 70 gene probes. This risk score has proven to be the most predictive indicator of the outcomes for myeloma patients, and led to the formation of a new company that makes this gene signature available to every clinic.
Serving as the statistical consultants for Celator Pharmaceuticals (since acquired by Jazz Pharmaceuticals), CRAB biostatisticians were instrumental in generating the design of a successful randomized Phase 3 study in high-risk secondary Acute myeloid leukemia (AML). This trial enrolled over 300 patients and met its primary objective of showing superior survival in the patients treated with the new drug regimen. Sophisticated analyses taking account of time of transplant and other time-dependent covariates were generated to support the primary efficacy finding.
The “ctDNA to Monitor Treatment Response” (ctMoniTR) project aims to study circulating tumor DNA (ctDNA) as a non-invasive monitoring tool for evaluating tumor response and as a potential surrogate endpoint. CRAB currently serves as the Independent Analysis Center (IAC) for the ctMoniTR project, which is sponsored by Friends of Cancer Research, a non-profit cancer research think tank and advocacy organization located in Washington DC.
As the IAC for the ctMoniTR Project, CRAB securely received clinical and ctDNA assay data from academic, pharmaceutical, and sequencing companies, coordinated input from collaborators, merged and pooled datasets, and analyzed the aggregated dataset to meet the project’s objectives. During this project, CRAB developed data dictionaries and statistical analysis plans, as well as cleaned, mapped, and harmonized disparate datasets from multiple clinical studies. Results from the analyses will eventually be used to assist clinicians in using ctDNA to guide patient care, as well as to investigate ctDNA assays as potential companion diagnostics or qualified biomarker.