Epidemiology and Biostatistics

ToxStrategies Consulting Services, and our division EpidStrategies, are founded on rigorous scientific principles that guide our research on complex health conditions. With a focus on pharmaceuticals, medical devices, nutritional products, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiological studies. Our research frequently results in peer-reviewed publications and presentations at scientific conferences and is also used in numerous regulatory documents in the US and Europe.

Core Services

  • Assisting clients in evaluating their need for epidemiological support • Designing and implementing research studies
  • Managing small and large data sets • Conducting statistical analyses, meta-analyses, and pooled Individual Patient Data (IPD) analyses
  • Conducting systematic literature reviews following established guidelines such as PRISMA, STROBE, and MOOSE
  • Writing scientific manuscripts following the guidelines of the International Committee of Medical Journal Editors (ICMJE)
  • Developing epidemiology sections for orphan drug applications, risk management plans, and other regulatory documents
  • Designing, conducting, and analyzing basic clinical trials, as well as conducting post hoc analyses
  • Providing training courses for clients in statistical software use and statistical methods and analyses

Research Study Development and Conduct

  • Study protocol development
  • Institutional Review Board applications
  • Design of collaborative studies with US and international medical centers
  • Study implementation and project management

Examples

  •  Longitudinal study of RSV phenotypic characterization and time trends in hospitalization
  •  Cohort study of patients at high risk for CVD, including lipid-lowering therapy prescribing patterns, cholesterol levels, and CVD event rates
  •  Retrospective cohort of cold agglutinin disease patients: demographic and clinical characterization and risk of adverse events
  •  Healthcare resource utilization and costs for Medicare-insured ESRD patients with arteriovenous grafts and fistulae

Databases Used

  • Surveillance, Epidemiology, and End Results Program (SEER)
  • National Health and Nutrition Examination Survey
    (NHANES)
  • National Death Index (NDI)
  • The Healthcare Cost and Utilization Project (HCUP)
  • The Health and Retirement Survey
  • CMS (Medicare) Claims
  • U.S. Census Bureau’s American Community Survey
  • U.S. Renal Data System (USRDS)
  • Optum database
  • Assistance in collaborations with proprietary client databases

Software tools

  • Comprehensive Meta-Analysis (CMA)
  • R
  • SEER*Stat
  • SAS
  • Stata
  • ArcGIS

Data Management and Statistical Analysis

  • Study design consultation
  • Randomization scheme design
  • Preparation of Statistical Analysis Plans
  • Data management, including complex data linkages
  • Conduct of statistical analyses, including: linear and non-linear regression models, multilevel models for dependent data, pooled (IPD) analysis, analyses of complex sample survey data

Examples

  • Statistical analysis of cross-over trial evaluating nutritional products for glycemic control
  • Systematic meta-analysis of arteriovenous fistulae patency
  • Pooled IPD analysis of growth and tolerance of partially hydrolyzed whey infant formula

Critical Evaluations of Epidemiologic Data and Studies

  • Systematic literature reviews and meta-analysis, including: Risk of bias for internal validity, Evaluating publication bias and heterogeneity, Sensitivity analyses
  • Technical comments to regulatory agencies and entities, including FDA and EFSA
  • Targeted literature reviews
  • Evidence-based causation analyses using Bradford-Hill criteria
  • Evaluation of study design and limitations