Evidence map›Paper›PMID 41971155›Full record

ArticleBMJ oncology2026

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

Saeid Shahraz, On Yee Wong, Rina Chotai, Sarah Knight, Denise Globe, Mira J Patel, Ankita Kaushik, Olalekan Lee Aiyegbusi, Melanie Calvert

Abstract read
In one paragraph

Article in BMJ oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Saeid ShahrazGlobal Value & Access, Health Economics Outcomes Research, Center of Excellence, Gilead Sciences Inc, Foster City, California, USA.ORCID https://orcid.org/0000-0003-4550-3843
On Yee WongClarivate Plc, London, UK.ORCID https://orcid.org/0009-0007-6641-2023
Rina ChotaiClarivate Plc, London, UK.ORCID https://orcid.org/0009-0006-9975-8277
Sarah KnightClarivate Plc, London, UK.
Denise GlobeGilead Sciences Inc, Foster City, California, USA.
Mira J PatelGilead Sciences Inc, Foster City, California, USA.ORCID https://orcid.org/0009-0005-3211-9334
Ankita KaushikGilead Sciences Inc, Foster City, California, USA.
Olalekan Lee AiyegbusiDirector of the Centre for Patient Reported Outcomes Research, University of Birmingham (working as an independent private consultant), Birmingham, UK.ORCID https://orcid.org/0000-0001-9122-8251
Melanie CalvertDirector of the Centre for Patient Reported Outcomes Research, University of Birmingham (working as an independent private consultant), Birmingham, UK.ORCID https://orcid.org/0000-0002-1856-837X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Breast cancer (female)Clinical TrialGastric cancerLung cancer (non-small cell)Oesophageal cancer

Identifiers

PMID41971155
PMCPMC13064142

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.