Description of study population: breast cancer, ALS

Use Case 1 (description of the study population) aims to assess the value of real-world data (RWD) from national healthcare registers and claims data in generating high-quality, accessible, population-based information on amyotrophic lateral sclerosis and breast cancer (diagnosis, treatment, outcomes).

woman at laptop
© Adobe Stock/Andrey Popov

Real4Reg will examine and display the heterogeneity of people affected by breast cancer or amyotrophic lateral sclerosis (ALS):

  • We will describe the natural history of ALS, its incidence, prevalence, mortality, survival time and signals for disease progression.
  • We will describe the natural history of breast cancer, its incidence, prevalence, 5-year and 10-year recurrence-free survival, mortality, and signals for disease progression. We will also describe changes in the standard of care for breast cancer in general and identify breast cancer subtypes in different data.

We will describe the heterogeneity in the context of data captured depending on the source including coding practices in the four partners, accessibility, representativeness, temporal variation, bias, and completeness.

This information can be useful for the design of comparative effectiveness studies that support reimbursement decisions (e.g., some subgroup analyses that were not included in a clinical trial).

Information for Patients

Our website comprises a section dedicated to the public and particularly patients. Our patient organisations partners (EUpALS and EIWH) were actively involved in developing the content.

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In this use case, we will also analyse the accessibility and usability of the different data sources for describing the study population in clinical trials differentiated for breast cancer and ALS. In doing so, we describe similarities and differences between countries and data sources included.

We will employ workflows that allow users to:

  • select patients in real-world datasets by demographic characteristics, diagnoses, and medication(s).
  • display patient trajectories in RWD, e.g., via Sankey diagrams.
  • compare patient characteristics of ALS and breast cancer included in clinical trials with those observed in real-world datasets.

Overview: All Use Cases

Use Case 1: Description of study population: breast cancer, ALS
Use Case 2: Historical controls and synthetic data: breast cancer, ALS
Use Case 3: Safety: fluoroquinolones
Use Case 4: Effectiveness and drug repurposing: SGLT2 Inhibitors