Biostatistics

Our Biostatisticians are Experts in Clinical Trials, Molecular Biomarker Assessment, Cancer Staging, and Statistical Methodology

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.

Staging

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.

Genetic Predictors

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.

Learn more on our Friends of Cancer Research collaboration page

Registration Trials

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.

Cancer Biomarkers

CRAB 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. We also developed a risk score based on gene expression profiling that has proven to be the most predictive indicator of the outcomes for myeloma patients.

Ovarian Tumor Microenvironment
Ovarian Tumor Microenvironment

We Conduct Phase I Through Phase III Multi-Institutional Trials

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 trials.

Among the services we offer are:

  • Design of clinical trials, including selection of most appropriate endpoints and sample size and power calculations
  • Development of Statistical Analysis Plans (SAPs)
  • Development and generation of interim analyses
  • Participation on Data Safety Monitoring Committees (DSMC/DMC)
  • Generation of DSMC reports and providing Independent Statistician in support of DSMC Meetings
  • Review of electronic case report forms for compliance to Clinical Data Acquisition Standards Harmonization (CDASH) standards
  • Developing and maintaining web-based reports on protocol status, survival endpoints, response and toxicities
  • Analyzing clinical and correlative data for peer-reviewed manuscripts, scientific abstract submissions and presentations
  • Preparing materials for and participating in FDA meetings

Our biostatisticians provide other cancer-related services including:

  • Analysis of high-dimensional data such as gene expression and single nucleotide polymorphism (SNP) data to identify reproducible genetic markers
  • Statistical support to cancer staging projects
  • Cutting edge methodological research on novel clinical trial designs

Data Metrics: We build and deliver reports critical to the overall management of your study.

Data Protection: Our state-of-the-art Data Center keeps your electronic data safe and secure at all times. In addition, we routinely back-up your data to an off-site location as part of our disaster preparedness plan.