ArticleCancer medicine2021
Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.
Article in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic Review of Patient-Reported Measures for Individuals Who Underwent Genetic Testing for Heritable Cancer.The patient · 2026Pooled it
- Measuring toxicity better: patient-reported outcome-informed calibration for CTCAE assessment.Translational cancer research · 2026Article
- Beyond Survival: Measuring Treatment Tolerability with Patient-Reported Outcomes in the Lymphoma Immunotherapy Era.Current hematologic malignancy reports · 2026Review
- PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.Statistical methods in medical research · 2026Article
- A single item for overall side effect impact: Association with clinician-reported adverse events and global health.Clinical trials (London, England) · 2026Article
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Systematic evaluation of patient-reported outcomes in clinical trials of digital health in cardiovascular diseases.NPJ digital medicine · 2025Article
- Association Between Health-Related Quality of Life Measures and Survival Endpoints in Oncology Clinical Trials and in Clinical Decision Making: A Narrative Review.Pharmaceutical medicine · 2025Review
- Burden of lung cancer and application of patient-reported outcomes in the Western Pacific Region: a systematic analysis.Frontiers in medicine · 2025Article
- Determining doses for backfill cohorts based on patient-reported outcome.BMC medical research methodology · 2024Article
- Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.EClinicalMedicine · 2024Review
- Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs.Research involvement and engagement · 2024Article
- Statistical methods and data visualisation of patient-reported outcomes in early phase dose-finding oncology trials: a methodological review.EClinicalMedicine · 2023Article
- A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.British journal of cancer · 2023Article
- Clinical outcome assessment trends in clinical trials-Contrasting oncology and non-oncology trials.Cancer medicine · 2023Article
- Trends in Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review.Orthopaedic journal of sports medicine · 2023Review
- Chimeric Antigen Receptor T-cell Therapy in Hematologic Malignancies and Patient-reported Outcomes: A Scoping Review.HemaSphere · 2022Article
- Patient-Reported Outcomes in Early Phase Clinical Trials: An Opportunity to Actively Promote Patient-Centered Care.The oncologist · 2022Article
- Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.The oncologist · 2022Article
- Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer medicine · 2021Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatient-reported adverse events (AEs) may be a useful adjunct to clinician-assessed AEs for assessing tolerability in early phase, dose-finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient-reported outcome (PRO) use.
methodsDFOTs commencing 01 January 2007 - 20 January 2020 with 'PROs' or 'quality of life' as an outcome were extracted and inclusion criteria confirmed. Study and PRO characteristics were extracted. Completed trials that reported PRO outcomes and published manuscripts on ClinicalTrials.gov were identified, and PRO reporting details were extracted.
results5.3% (548/10 372) DFOTs included PROs as an outcome. 231 (42.2%) were eligible: adult (224, 97%), solid tumour (175, 75.8%), and seamless phase 1/2 (108, 46.8%). PRO endpoints were identified in more trials (2.3 increase/year, 95% CI: 1.6-2.9) from an increasing variety of countries (0.7/year) (95% CI: 0.4-0.9) over time. PROs were typically secondary endpoints (207, 89.6%). 15/77 (19.5%) completed trials reported results on the ClinicalTrials.gov results database, and of those eight included their PRO results. Eighteen trials had published manuscripts available on ClinicalTrials.gov. Three (16.7%) used PROs to confirm the maximum tolerated dose. No trials identified who completed the PROs or how PROs were collected.
conclusionsPRO use in DFOT has increased but remains limited. Future work should explore the role of PROs in DFOT and determine what guidelines are needed to standardise PRO use.
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Registered trials
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.