CERGAS Seminar "Evidence generation and use of patient-reported outcomes: the PRO4all project"

Coauthors: Oriana Ciani and Michela Meregaglia (CERGAS SDA Bocconi)

In recent years, attention to the use of PROs (patient reported outcomes) has gradually increased in the wake of the transformation toward a patient-centered approach to the drug development process and health service delivery, in general. These dimensions are measured through tools, scales, and questionnaires (patient reported outcome measures, PROMs) that, combined with clinical data, provide a more complete picture of patient health status to inform shared choices, personalized care, and approval and reimbursement decisions.

Recently, the European Medicines Agency (EMA) and the Italian Medicines Agency (AIFA) have advocated the adoption of a patient-centered approach, incorporating the patient's voice through the use of PRO/PROMs in evidence generation. In clinical research, the use of PRO/PROMs is not always consistent and standardized, reducing their adoption and value, even when they are crucial for additional treatment evaluation. Recently, digital solutions (e-health) have emerged as a facilitating factor in enabling a broader and more standardized collection of PROs. These considerations led to the start of PRO4all project with the overall goal of consolidating awareness of the potential offered by PRO/PROMs among various stakeholders in the drug development pathway (e.g., patients, clinicians, scientific societies, decision makers).

More specifically, the project's objectives were:

- To investigate the role of PROs, in terms of clinical trial registration, EMA evaluations through the publication of EPARs (European public assessment reports) and in AIFA's decisions on approval, reimbursement and possible innovativeness in the national territory.

- To map the PROMs available in oncology, developing an accessible repository of them and bringing out which outcome domains (PROs) are covered by the tools (PROMs) currently available.

The seminar will illustrate the main findings published in four different peer reviewed manuscripts and the accompanying dissemination activities performed with the stakeholders in the drug related decision-making process.

Speaker:

Francesco Malandrini is Knowledge Analyst at SDA Bocconi School of Management in the Government, Health and Non Profit (GHNP) Division. He is member of CeRGAS Observatory on Pharmaceuticals and Pharmaceutical Policies (OSFAR). He holds a PharmD degree from the University of Eastern Piedmont. The core research themes in his work include pharmacoeconomics, patient-reported outcomes, pharmaceutical policies, market access and P&R of medicines.

Link zoom: https://unibocconi-it.zoom.us/j/98682204675?pwd=cUhtOHVwTnVkVlBVb1N3MVFOK2M3UT09

Meeting ID: 986 8220 4675

Passcode: 740781

Lunch bags at the end of the meeting: for those willing to participate in person, click here before the 12th of December.