Communicating clinical trial information about cancer drug products to patients and healthcare professionals: review of patient-reported outcome messaging

Objectives: Patient-reported outcomes (PROs) are essential for understanding how cancer treatments affect individuals’ symptoms, daily functioning and quality of life. This study examined how PRO data from pivotal clinical trials in breast cancer (BC), gastrointestinal (GI) cancers and non-small cell lung cancer (NSCLC) are reflected in regulatory drug labels and public-facing communications such as American Society of Clinical Oncology daily news. The goal was to identify gaps in the communication of these data, particularly in formats accessible to non-technical audiences and to highlight opportunities for improvement.

Methods and analysis: We conducted a targeted review of oncology drugs approved between 2014 and 2024 by the US Food and Drug Administration and the European Medicines Agency. For each product, we assessed pivotal trials for PRO endpoints and reviewed regulatory labels for PRO claims. Public-facing materials—including sponsor websites, medical society platforms and patient advocacy content—were evaluated for the presence, clarity and visibility of PRO messaging. Messaging strength was internally rated as low, medium or high.

Results: Among 128 pivotal trials (28 BC, 34 GI, 66 NSCLC), 105 (82%) included PROs—84 as secondary and 40 as exploratory endpoints. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) was used in 83 trials (79.0%), and EuroQol Group in 72 (68.6%). Only 10 products included PRO content in their regulatory labelling. Of 16 BC drugs, all had PRO data, but only 4 had regulatory PRO claims. Most sponsor websites lacked PRO content; only seven products across all indications included healthcare professional-facing PRO narratives and only two on patient-facing websites. No product achieved a high messaging strength rating; 53 of 64 rated products were categorised as low (limited or no PRO communication).

Conclusions: Despite widespread PRO data collection, integration into labelling and public communication remains limited. While label inclusion supports compliant dissemination, some PRO findings appear in public materials without formal claims. Advancing both methodological rigour and clear regulatory guidance is essential to promote balanced, patient-relevant communication in oncology.