SynthesisJournal of the National Cancer Institute2021
Patient-Reported Outcomes in Clinical Trials Leading to Cancer Immunotherapy Drug Approvals From 2011 to 2018: A Systematic Review.
Synthesis in Journal of the National Cancer Institute, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05812274 (A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer), which is not on this map. Cited by 20 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.
A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Social determinants of health in studies using PROMs to assess toxicities associated with immune checkpoint inhibitor treatment: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Patient-reported quality-of-life outcomes in immune checkpoint inhibitor therapy: addressing gaps, capturing patient experience, and advancing the field.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- The opportunities and barriers for developing tumour-infiltrating lymphocyte therapy for patients with advanced genitourinary cancers.Nature reviews. Urology · 2026Review
- Increasing Life Expectancy in Patients with Genitourinary Malignancies: Impact of Treatment Burden on Disease Management and Quality of Life.European urology · 2025Review
- Revitalizing oncology medications access in Saudi Arabia: Current challenges and recommendations by the Saudi Oncology Pharmacy Assembly.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2025Article
- Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005-2020: an observational study.The Lancet regional health. Western Pacific · 2024Article
- Analyses of quality of life in cancer drug trials - a review of measurements and analytical choices in post-reimbursement studies.BMC cancer · 2024Review
- 15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis.EClinicalMedicine · 2024Article
- Clinical outcome assessment trends in clinical trials-Contrasting oncology and non-oncology trials.Cancer medicine · 2023Article
- Patient-reported outcomes in CD30-directed CAR-T cells against relapsed/refractory CD30+ lymphomas.Journal for immunotherapy of cancer · 2023Article
- Patient-reported outcomes in metastatic renal cell carcinoma trials using combinations versus sunitinib as first-line treatment.Nature reviews. Urology · 2023Review
- Analysis of patient-reported outcomes in the approval of novel oncology drugs in the United States, 2017-2022.EClinicalMedicine · 2023Review
- Symptom Trajectories Informing Patient Care After Lung Cancer Surgery: A Longitudinal Patient-Reported Outcome Study.Annals of surgical oncology · 2023Article
- Patient-Reported Outcomes in Cancer Patients with HIV.Cancers · 2022Article
- Statistical methods and graphical displays of quality of life with survival outcomes in oncology clinical trials for supporting the estimand framework.BMC medical research methodology · 2022Review
- Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments.Current oncology (Toronto, Ont.) · 2022Review
- Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer.Translational oncology · 2022Review
- Evaluation of Patient-Reported Outcomes (PROs) Protocol Content and Reporting for Clinical Trials that Lead to the approval of frontline Immune Checkpoint Blockade Combination for Patients with Advanced Renal Cell Carcinoma - The Patients' Voice or a Missed Opportunity.Clinical genitourinary cancer · 2022Article
- A 15 Year Review (2006-2020) of Patient-Reported Outcome (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience.Archives of internal medicine research · 2022Article
- The current issues and future perspective of artificial intelligence for developing new treatment strategy in non-small cell lung cancer: harmonization of molecular cancer biology and artificial intelligence.Cancer cell international · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundPatient-reported outcomes (PROs) promote patient centeredness in clinical trials; however, in the field of rapidly emerging and clinically impressive immunotherapy, data on PROs are limited.
methodsWe systematically identified all immunotherapy approvals from 2011 through 2018 and assessed the analytic tools and reporting quality of associated PRO reports. For randomized clinical trials (RCTs), we developed a novel 24-point scoring scale: the PRO Endpoints Analysis Score based on 24 criteria derived from the recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.
resultsWe assessed 44 trial publications supporting 42 immunotherapy approvals. PROs were published for 21 of the 44 (47.7%) trial publications. Twenty-three trials (52.3%) were RCTs and 21 (47.7%) pertained to single-arm trials. The median time between primary clinical outcomes publications and their corresponding secondary PRO publications was 19 months (interquartile range = 9-29 months). Of the 21 PRO reports, 4 (19.0%) reported a specific hypothesis, and most (85.7%) used descriptive statistics. Three (3 of 21 [14.3%]) studies performed a control for type I error. As for RCTs, 14 of 23 (60.9%) published PRO data, including 13 (56.5%) that published a secondary dedicated manuscript. One-half of these 14 trials scored less than 13 points on the 24-point PRO Endpoints Analysis Score. The mean score was 12.71 (range = 5-17, SD = 3.71), and none met all the recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.
conclusionsSuboptimal reporting of PROs occurs regularly in cancer immunotherapy trials. Increased efforts are needed to maximize the value of these data in cancer immunotherapy development and approval.
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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.