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. 2025 Jun 17;4(1):e000783.
doi: 10.1136/bmjonc-2025-000783. eCollection 2025.

Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM)

Alberto Puccini  1   2 , Giuseppe Viscardi  3 , Oriana Ciani  4 , Fabio Efficace  5 , Angela Piattelli  6 , Giordano Domenico Beretta  7 , Davide Petruzzelli  8 , Patrizia Popoli  9 , Francesco De Lorenzo  10 , Francesco Longo  11 , Marco Zibellini  12 , Lara Gitto  13 , Antonella Brunello  14 , Evaristo Maiello  15 , Alberto Servetto  16 , Martina Pagliuca  17 , Alessandra Raimondi  18 , Laura Marandino  19 , Saverio Cinieri  20 , Elisabetta Iannelli  21 , Carla Ida Ripamonti  22 , Paolo Bossi  1   2 , Gianmauro Numico  23 , Tiziana Latiano  15 , Carmine Pinto  24 , Silvana Quaglini  25 , Laura Locati  26 , Gualberto Gussoni  27 , Gianluca Mignone  28 , Pricivel M Carrera  29 , Ethan Basch  30 , Massimo Di Maio  31 , Francesco Perrone  32
Affiliations

Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM)

Alberto Puccini et al. BMJ Oncol. .

Abstract

Objective: Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Italian Association of Medical Oncology, held in Bologna on 21-22 June 2024, with a focus on the integration and impact of PROs in oncology research and clinical practice.

Methods and analysis: Leading national and international experts presented and analysed data regarding the use of PROs in clinical trials and routine oncology care. Topics included the role of electronic PROs (ePROs), digital therapeutics, financial toxicity as a PRO and methodologies for standardising QoL assessment. Insights were drawn from expert presentations, consensus discussions and practical experiences shared during the conference sessions.

Results: Experts emphasised that PROs should be included as key endpoints in clinical trials, with timely publication of results and standardised methodologies for analysis and interpretation. The conference highlighted the critical importance of incorporating PROs and QoL measures throughout the cancer care continuum-from screening to survivorship. In clinical practice, PROs improve patient-centred care and communication, particularly when oncologists are trained to interpret QoL data. The use of ePROs was noted as a valuable tool to support digital health interventions. Financial toxicity emerged as a significant PRO, with screening tools recommended to identify and support at-risk patients. Key organisational challenges were identified, including technological barriers, resource constraints and the need for responsive infrastructure to support real-time PRO integration.

Conclusion: The implementation of PROs, including ePROs and financial toxicity assessments, is essential for advancing quality cancer care. Standardisation, digital innovation and targeted clinician education are critical to integrating PROs effectively in both research and clinical settings. Addressing infrastructural and technological challenges will be vital for optimising patient outcomes and ensuring optimal care across the cancer journey.

Keywords: Adverse effects; Clinical Trial; Patient Safety; Psycho-oncology.

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Conflict of interest statement

FP: reports honoraria from Pfizer, Glaxo, Bristol Myers Squibb, Menarini, Roche, Viatris Italia for consultancy or participation to advisory boards; AIOM President. MDM reports honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche. SC: reports honoraria from Lilly oncology, Menarini Stemlines, Lilly oncology, past president AIOM and Presidente AIOM Foundation. AP: reports honoraria from GlaxoSmithKline, Takeda Pharmaceuticals USA, Takeda Italia, Bayer, Daiichi Sankyo Italia, MSD Italia for consultancy or participation to advisory boards; from Pierre Fabre, Servier, Amgen as Invited Speaker; institutional funding for work in clinical trials/contracted research from GlaxoSmithKline, Amgen; from AstraZeneca, Amgen, Merck Serono for Travel, Accommodations, Expenses. All not related to this manuscript. AR: reports honoraria for speaker bureau and advisory board participation: Elma Academy, Servier, MSD, Nordic Pharma. PB: Participation to advisory board or conference honoraria for Merck, Sanofi-Regeneron, Merck Sharp from Pharmamar for travel and accommodation expenses. FE: consultancy or advisory role for AbbVie, Incyte, Novartis and JAZZ Pharmaceuticals. Research funding (institution) from Daiichi Sankyo. All are not related to this manuscript. MP: reports honoraria from Ipsen for travel and accomodation expenses; from Gilead for Research funding (to institution). GV: reports honoraria from MSD, Novartis for consultancy or participation to advisory boards; From Astra Zeneca, Novartis, Sanofi for Travel accommodation; from AstraZeneca, BMS, Merck, MSD, Regeneron, Roche, Takeda for Speaker fee CP: outside the submitted work personal fees for the advisory role, speaker engagements, and travel and accommodation expenses from Amgen, Astellas, AstraZeneca, Bayer, Bristol Meyer Squibb, Celgene, Daiichi Sankyo, Eisai, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, Sandoz, Sanofi, and Servier. LM: outside the submitted work personal fees for Speakers’ Bureau: Gilead Sciences, Merck; Research Funding: AstraZeneca; Travel, Accommodations, Expenses: Janssen, Immunocore.

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