Real World Databases
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Real World Data (TherapieMonitor)

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

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 and anonymized 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 not obligatory. Optional: Patient reported healthcare resource utilization, drug adherence

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 (max. 4 months after contracting)

  • Descriptive statistics
  • Patientflow in course of disease, treatment duration, treatment free periods
  • Treatment algorithm in clinical reality in comparison with the clinical guidelines, gap analysis, clinical pathway
  • Treatment management (agents, dosage, intervalls, number of administrations, duration of treatment) and adjustments in course of treatment
  • Key drivers for treatment choice (multivariate analysis)
  • Predictive modeling for the use of specified regimens/agents