Real World Evidence in Oncology: an Italian examples-based expert opinion on advancing clinical and regulatory decision-making

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Healthcare resource utilisation

  Method development or testing
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Uterine cancer

  Prostate cancer metastatic

  Breast cancer

  Lung cancer metastatic

  Diffuse large B-cell lymphoma

Population studied

• Short description of the study population:
  Italian inhabitants beneficiaries of the Italian National Health Service (SSN) included in the ReS database. All subjects who had received a diagnosis of cancer (according to the specific code of the ICD9-CM system,; which allows a standardized classification of the different tumor sites) in the period between 2014 and 2022; were considered.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  Patients with tumor from 2014 to 2022 were identified and analysed as prevalent cases and/or incident cases. Epidemiology and demographics were described at baseline. According to the specific objective, drug utilisation and healthcare utilisation could also be assessed.
• Main study objective:
  The RWE Oncology Project aims to reach a consensus on the use of Real-World Data (RWD), in particular; administrative health data, to identify eligible patients (target populations) for new oncology drugs and analyze; them in their different peculiarities.; This report illustrates some examples of identification of populations affected by specific tumors and analyses; that can be conducted to generate Real World Evidence (RWE) in the oncology field, in order to suggest how; administrative health data can be used for different analytical purposes.
• Setting:
  Inhospital/local outpatient settings