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

Study identification

• EU PAS number:
  EUPAS1000000624
• Study ID:
  1000000624
• Official title and acronym:
  Real World Evidence in Oncology: an Italian examples-based expert opinion on advancing clinical and regulatory decision-making
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Real World Evidence (RWE) is transforming oncology by integrating insights from randomized clinical trials (RCTs) with real-world data, enhancing personalized care, optimizing treatments, and informing clinical and regulatory decisions. ; This expert opinion, based on a multidisciplinary Italian project, demonstrates RWE’s ability to address gaps in RCTs, especially for complex or underrepresented populations, using case studies from the Fondazione Ricerca e Salute (ReS) healthcare database. While RWE shows transformative potential, challenges remain in data quality, accessibility, and regulatory integration. Experts emphasize standardizing data collection and harmonizing methodologies across healthcare systems to ensure actionable insights. ; RWE is also crucial for pricing, reimbursement, and regulatory approvals, particularly in cases where large-scale trials are infeasible or raise ethical concerns. The integration of artificial intelligence tools is highlighted as essential for advancing data processing and analysis, enabling RWE to provide more nuanced insights. Collaboration among healthcare providers, researchers, and policymakers is critical to harness RWE’s full potential. ; By addressing these challenges, RWE can improve patient outcomes, streamline resource allocation, and enhance decision-making in oncology, driving progress toward more efficient and personalized cancer care.; This study highlights how real-world evidence complements clinical trials, advancing precision oncology and supporting regulatory and healthcare decision-making for improved patient outcomes.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fondazione ReS (Ricerca e Salute), CINECA partner

Italy

Study timelines

Date when funding contract was signed

Actual: 07/02/2023

Study start date

Actual: 03/07/2023

Date of final study report

Actual: 01/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

unconditional contribution of: AstraZeneca S.p.A., Glaxosmithkline S.p.A., Pfizer S.r.l., Roche S.p.A

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable