How close are the clinical studies required for the approval of a drug to the reality of the patient? This is research work that is carried out on selected patient populations. Therefore, it is important to continue studying a drug in real life even after it has been introduced to the market. In Italy i real datathis is real life, for various reasons they are still underused and little used, but doctors, pharmaceutical companies, regulators and health authorities are becoming interested in them.

“Real-world data can be used to complement the scientific evidence obtained from randomized controlled trials,” he affirms Alessandra Gennari, Professor of Oncology at the University of Eastern Piedmont and Director of the University Structure of Medical Oncology at the Maggiore Hospital of Novara. “In real-world data, patient characteristics may differ slightly from those of patients involved in randomized clinical trials, and this may account for slightly different drug efficacy in clinical practice.” reflect clinical practice, but are not sufficient to approve a drug, since a study with a control arm with standard therapy is always necessary.”

Breast cancer: how to evaluate the effectiveness of drugs in real life?

A paradigmatic example of the value of real data in oncology is lo P-REALITY-X studydeveloped by Pfizer to help understand the efficacy of first-line combination therapy of palbociclib with an aromatase inhibitor in a real-world setting, which is critical to improving patient care metastatic breast cancer.

“The P-REALITY-X study is a real-world study evaluating the efficacy of palbociclib that demonstrated survival and progression-free survival benefit in the cohort of patients
received palbociclib with an aromatase inhibitor with an increase in survival from 43 months to 57 months,” he explains Joseph CuriglianoProfessor of Medical Oncology at the University of Milan and Director of the Department for the Development of New Drugs for Innovative Therapies, European Institute of Oncology in Milan.

Real-world studies are now considered to complement, not replace, randomized clinical trials that confirm the effectiveness of a new treatment. In addition, they represent valuable data for deepening, above all, the safety profile of a medicinal product and therefore make it possible to fill important gaps in the scientific panorama.