ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2023
International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.
Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled 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.
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
8 citing papers in PubMed, 1 synthesis or guideline 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
- Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients.Cancer medicine · 2025Trial
- Dynamic prediction of adverse outcomes in discharged COPD patients using patient-reported outcomes.BMC medical research methodology · 2026Observational
- Measuring What Matters: RECIST Response Does Not Predict HRQoL in Early-Phase Clinical Trials.Cancers · 2026Article
- Review
- Symptom and functional networks of patients with cancer in different latent risk subgroups based on patient-reported outcomes.BMC cancer · 2025Article
- Using patient-reported outcome measures in clinical trials: perspectives for and against a modular approach.The Medical journal of Australia · 2025Article
- Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial.JMIR research protocols · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field.
Indexed as
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What OpenQuestion holds
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.