ArticleLeukemia2017
The relationship between eligibility criteria and adverse events in randomized controlled trials of hematologic malignancies.
Article in Leukemia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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, 25 citations in OpenAlex.
- Defining and predicting disease progression in myeloproliferative neoplasms: a proposed biomarker-driven approach.Leukemia · 2026Review
- Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement.Blood · 2025Article
- Drug development in higher-risk myelodysplastic syndromes.Blood cancer journal · 2024Article
- CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial.Cancers · 2024Article
- Survival of patients with newly diagnosed high-grade myeloid neoplasms who do not meet standard trial eligibility.Haematologica · 2021Article
- Characterizing inclusion and exclusion criteria in clinical trials for chimeric antigen receptor (CAR) T-cell therapy among adults with hematologic malignancies.Journal of geriatric oncology · 2021Article
- Eligibility of real-world patients with metastatic breast cancer for clinical trials.Breast (Edinburgh, Scotland) · 2020Article
- Representation of therapy-related myelodysplastic syndrome in clinical trials over the past 20 years.Blood advances · 2019Article
- New drugs in AML: uses and abuses.Leukemia · 2018Article
- Article
- The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.Journal of the American Medical Informatics Association : JAMIA · 2018Article
- Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To minimize adverse events (AEs) unrelated to drugs and maximize the likelihood of drug approvals, eligibility criteria for randomized controlled trials (RCTs) may be overly restrictive. The purpose of this study was to determine if RCTs in hematologic malignancies exclude patients irrespective of known toxicities or observed AEs. MEDLINE was searched from 1/2010 to 1/2015 for RCTs published in high-impact journals. Of 97 trials, 33% were conducted in leukemia, 28% in lymphoma, 34% in multiple myeloma and 5% in myelodysplastic syndromes or myelofibrosis. Expected toxicities at thresholds of ⩾10%, ⩾5% and <5% were not correlated with cardiac, hepatic or renal eligibility criteria (logistic regression). To explore this lack of correlation we tested the concordance of expected toxicities and eligibility criteria using a modified version of McNemar's test: at each threshold, hepatic, renal and cardiac expected toxicities were significantly discordant with eligibility criteria. Hepatic and renal eligibility criteria were also not correlated with observed AEs, P=0.69 and P=0.77, respectively, but a significant correlation was detected between cardiac eligibility criteria and observed AEs, P=0.02. Thus, the analyzed RCTs excluding patients with organ dysfunction do not reflect expected toxicities, based on prescription drug labels/prior experience, or reported AEs on the trials.
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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.