ArticleESMO open2024
Association between health-related quality-of-life results, outcomes of efficacy and drug approvals: a meta-research study of randomized phase III trials in oncology.
Article in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Quality of Life Endpoints in Advanced Gastrointestinal Cancer Trials: Systematic Review of Inclusion, Challenges, and Implications (2020-2024).Clinical oncology (Royal College of Radiologists (Great Britain)) · 2026Pooled it
- Deriving Health Utility Values Using Mapping Methods Among the Chinese Population: A Systematic Review.Applied health economics and health policy · 2026Pooled it
- Health-related quality of life assessment in trials testing tyrosine kinase inhibitors or immune checkpoints inhibitors in early-stage NSCLC.The oncologist · 2025Pooled it
- First-line anlotinib versus bevacizumab plus CapeOX in RAS/BRAF wild-type unresectable metastatic colorectal cancer (ANCHOR): a multicenter, prospective, randomized, phase 3 trial.Signal transduction and targeted therapy · 2026Trial
- When Survival Improves But Quality of Life Does Not: A Model-Based Meta-Analysis of Immune Checkpoint Inhibitors.medRxiv : the preprint server for health sciences · 2026Article
- Quality of life in oncology drug approvals: evidence from Swiss decisions in relation to global regulatory trends.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Association of haematological cancer drugs recommendation levels in Chinese Society of Clinical Oncology guideline with different approval approaches: a cross-sectional study.BMJ public health · 2026Article
- Evaluating Food and Drug Administration approved gastrointestinal cancer drugs: clinical benefit and trial endpoints over the past two decades.The oncologist · 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
- Article
- Tearing down inequalities in the healthcare system across Europe: the BEACON project.Frontiers in public health · 2025Review
- Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite the interest from the scientific community and regulatory agencies, limited data are available on the association between health-related quality-of-life (QoL) results, outcome of efficacy and drug approvals. MATERIALS AND
methodsWe updated the previously published meta-research study of phase III clinical trials in patients with solid tumours treated with systemic treatments, published from 2012 to 2021 in 11 selected journals. For the present analysis, we focused on studies conducted in the advanced setting. The primary outcome was the association of global QoL results with study primary endpoints (EP1), overall survival (OS) and progression-free survival (PFS), while a secondary outcome was the frequency of positive global QoL results among treatments approved by regulatory agencies [European Medicines Agency (EMA)/Food and Drug Administration (FDA)]. A descriptive analysis was carried out and the association between QoL results and characteristics of studies and of publications was tested.
resultsFive hundred and ninety-two eligible publications were identified from 2012 to 2021. The primary endpoint was OS in 298 clinical trials (50.3%) and PFS in 304 clinical trials (51.4%). A positive result in EP1 analysis was reported in 124 trials (41.6%) with OS as EP1 and in 182 trials (59.5%) with PFS as EP1. Among studies with positive OS and PFS, global QoL results were positive in 39 (31.5%) and 45 studies (24.7%), respectively. FDA and EMA approvals were available for 143 (24.2%) and 142 studies (24%), respectively. Among these, global QoL results were positive in 55 (38.5%) and 56 studies (39.4%), respectively. QoL results were available for most drugs approved by regulatory agencies, but the proportion of approvals with positive global QoL results was not significantly increased from 2012-2016 to 2017-2021.
conclusionsDespite QoL data being available for most cancer treatments recently approved by regulatory agencies, QoL improvement has been demonstrated in a minority of studies with positive results in the primary endpoint.
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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.