The PRO4ALL working group was set up in 2021 with the aim of understanding the role of the “patient voice” in clinical research and regulatory pathways, with a specific focus to Patient Reported Outcomes (PROs) and their measurement. The working group comprises Associazione Italiana Oncologia Medica (AIOM), Associazione Italiana di Miologia (AIM), Associazione Italiana Sclerosi Multipla (AISM), Federazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Federazione dei Gruppi Cooperativi Oncologici Italiani (FICOG), Società Italiana di Neurologia (SIN), Federazione Italiana Malattie Rare(UNIAMO) together with SDA Bocconi and the unconditional funding from Roche.

Patient-reported outcomes refer to any data on a patient's health status that comes directly from the patient, without interpretation by the clinician or others. The measurement of PROs is done by means of instruments, scales and questionnaires, collectively called patient reported outcome measures (PROMs) which allow to gather the perspective of the individual living with the disease or receiving a given treatment on physical, emotional, cognitive, social functioning, and psychological well-being and health-related quality of life.

The PRO4ALL project has carried out several research projects over the last two years. From the evaluation of the role of PROs in EMA assessment reports between 2017 and 2022, to the analysis of the association between PROs and drug reimbursement class and innovative status assigned by AIFA. Among reports related to authorized medicines concerning neurological or oncology indications, 57% or 51% reported any use of PROMs, respectively.

One of the conclusion reached by the working group is that a harmonisation and standardisation of the use of PROs and PROMs in clinical research is required, together with a commitment of relevant institutions to ensure that patients are at the centre of evaluation processes at every stage of drug development.

In relation to this aspect, we developed a comprehensive archive of patient-reported outcome measures (PROMs) in oncology and identified their main characteristics and target outcome domains. 

The archive is available at this link.

This archive represents a useful tool for guiding researchers and practitioners in selecting the most suitable measures and fostering a patient-centered approach in clinical trials, clinical practice, and regulatory activities.


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