Mission
- To identify, develop and apply sound statistical foundations and innovative statistical methodology essential for the advancement of science at PHRI.
- To ensure accurate design, implementation and maintenance of study data.
Vision
The research activities of PHRI are provided with optimal quality data, and timely, responsive, state-of-the-art statistical and methodological support.
Areas of application
- Cardiovascular diseases – prevention, arrhythmias, acute coronary syndromes
- Stroke and cognitive function
- Cardiac and non-cardiac perioperative medicine
- Diabetes
- Obesity
- Renal disease
- Cancer
- Frailty
- Gastrointestinal disorders
Study Conduct
- Study conduct reporting (recruitment, data quality, adherence, compliance, outcomes, adjudication tracking, AEs/SAEs, etc.)
- Data transfers to external parties
- Central Statistical Monitoring
- Emergency unblinding
- Randomization irregularity resolution
- Data Safety Monitoring Board reporting (DSMB)
- Statistical Analysis Plan (SAP) development
- Communicate with sponsors and/or external statisticians for data reconciliation or analysis validation
Study Planning
- Consult on, and draft, statistical methods as per study design and research hypotheses for grants and/or protocols
- Provide sample size and power calculations
- Determine scope of work and budget for statistics resources
Study Close-Out
- Additional data quality reports to ensure critical variables for analysis are clean
- SAP finalization
- Final analysis and unblinding of study results to Principal Investigator
- Provide methods section, analysis and critical statistical review of main publication
Subsequent Publications
- Review proposals
- Develop SAP
- Conduct appropriate analyses
- Draft methods section and critically review manuscript
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Types of Work
- Intervention studies
- Drugs, devices, surgical interventions
- Phase II-IV and registries
- Clustered designs
- Non-inferiority hypotheses
- Epidemiologic studies – case-control, cohorts, cross-sectional
Regulatory Requirements
- US FDA – STDM, ADAM datasets for Clinical Data Interchange Standards Consortium (CDISC) standards
- PHRI is a proud Platinum sponsor of CDISC