Data from the Italian Medicines Agency's Monitoring Registries on various oncological drugs were analysed in a study entitled "Comparison of baseline characteristics of patients in Italian monitoring registries of oncological drugs and registrative clinical trials: a cross-sectional real-world study", published in the journal The Lancet Regional Health - Europe.

The AIFA Monitoring Registries platform, since its first establishment in 2005, was created to guide physicians and pharmacists in the therapeutic path for the purposes of NHS reimbursement of innovative and high-cost drugs, having as its main objective the appropriateness of use and the integration of Managed Entry Agreements (MEAs) in Italian clinical practice. The current platform, in operation since 2013, is a unique experience in the European context, thanks to which it is also possible to collect census and national "Real-world" data, with important returns on public health and pharmaco-epidemiology issues, as demonstrated by the analysis published in the Lancet journal.

This important study is the result of a fruitful and exemplary collaboration between the Agency and the Italian Association of Medical Oncology (AIOM), aimed at the scientific development of the Monitoring Registries' data and at restoring their value to the Italian and international scientific community.

The cross-sectional study compared certain characteristics at baseline (gender, age and ECOG performance status), among patients included in 129 AIFA oncology registries, for a total of approximately 420,000 treatments, with 87,452 patients enrolled in clinical trials for the same medicines in the same therapeutic indications. This comparison showed that patients treated in clinical practice are older both in absolute terms, with a median age difference of 5.3 years, and in terms of the percentage difference of patients aged 65 years or older (+17.2%). From the point of view of ECOG performance status, patients treated in the Italian clinical practice started at baseline with a score of 2 or higher were higher in relative terms than patients enrolled in the clinical trials, for a mean difference of 1.3%. The percentages of men and women initiated in clinical practice with respect to the frequencies of the relevant trials also showed differences, but only in certain tumour types.

The extracted data revealed substantial differences that could result from an excessive rigidity of the inclusion criteria of the experimental setting and that recommend caution in extending the results obtained from the trial to the specific context of Italian clinical practice.

In the "Analysis of monitoring registries" section of the AIFA website, the complete list of contributions developed with the collaboration of the institutions and scientific societies of reference in the various therapeutic areas is available.