Epidemiology and Biostatistics

ToxStrategies, and our division EpidStrategies, provide consulting services 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 consulting scientists aid clients in the conduct, evaluation, and interpretation of epidemiological studies. ToxStrategies’ research on behalf of our clients 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