OncologyInformationService
Real World Databases
Evidence based Healthcare and Market Research

Real World Evidence (Non-Interventional studies)

Objectives Description of clinical reality regarding patient characteristics, healthcare structures, diagnostics, biomarker testing, treatment algorithms and their compliance with clinical guidelines, gap analysis, outcomes and tolerability

Sample 5-10% of treated prevalence reported in a representative sample of centers reflecting the healthcare structure and distribution of treated prevalence in the respective country

Method Patient and clinical characteristics are collected to provide characteristics of target patient population and for the treatment algorithm. Data originates from patients records available in the participating sites and is collected retrospectively or prospectively from date of diagnosis to extraction date. The indication specific Case Report Form (eCRF) is in the local language and web-based. In updates the centers report follow up data and new incident patients continuously. Patient consent or ethic approval obligatory.

Contents The eCRF consists of modules for reporting the entire clinical pathway of the target population including diagnostics, socio-demographic characteristics, treatment regimens by lines of treatment, dosage, intervals and number of administrations incl. adjustments in course of treatment. Optional: report of healthcare resource utilization

Deliverables

  • Descriptive statistics
  • Treatment algorithm in clinical reality in comparison with the clinical guidelines, gap analysis
  • Treatment management (agents, dosage, intervalls, number of administrations, duration of treatment) and adjustments in course of treatment
  • Outcomes and tolerability analysis, overall survival, progression free survival
  • Key drivers for treatment choice (multivariate analysis)