{"title":"Discretionary exclusion criteria in oncology clinical trials and exclusion of people with psychiatric and cognitive disabilities.","authors":"Nicole D Agaronnik, Elyse R Park, Lisa I Iezzoni","doi":"10.1016/j.dhjo.2025.101824","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Clinical trial protocols often allow investigators discretion to determine whether individuals are eligible to participate.</p><p><strong>Objective: </strong>To examine the frequency and impact of discretionary eligibility criteria in oncology clinical trials, including whether they specifically target populations with psychiatric or cognitive disabilities for exclusion.</p><p><strong>Methods: </strong>We identified interventional Phase III and Phase IV oncology clinical trials on ClinicalTrials.gov starting between January 1, 2019, and December 31, 2023. Among these, we included trials with at least one US location, patient populations aged 18-65 or 65+, and a posted study protocol. We used descriptive statistics to capture prevalence of broad investigator discretion in eligibility criteria. We reviewed statements concerning discretionary eligibility criteria for text relating to psychiatric or cognitive disability, and we applied qualitative content analysis techniques to identify themes.</p><p><strong>Results: </strong>Ninety-six trials met inclusion criteria for this study. Of these, 82 (85.4 %) of trials allowed broad investigator discretion to determine eligibility. Content analysis revealed concerns about participants' safety (i.e., posing undue risk to patients), potential difficulties adhering to study protocols (e.g., because of patients' physical, psychiatric, or social condition), perceived ability to obtain informed consent, and completing assessments of patients to determine results of interventions. All trials required informed consent.</p><p><strong>Conclusions: </strong>Most oncology clinical trials allow investigators broad discretion in determining the eligibility of individuals to participate. These discretionary criteria may particularly target persons with psychiatric or cognitive disabilities, excluding them from participating in clinical trials. Further research should examine whether certain rationales for excluding these populations are appropriate.</p>","PeriodicalId":49300,"journal":{"name":"Disability and Health Journal","volume":" ","pages":"101824"},"PeriodicalIF":3.7000,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Disability and Health Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.dhjo.2025.101824","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Clinical trial protocols often allow investigators discretion to determine whether individuals are eligible to participate.
Objective: To examine the frequency and impact of discretionary eligibility criteria in oncology clinical trials, including whether they specifically target populations with psychiatric or cognitive disabilities for exclusion.
Methods: We identified interventional Phase III and Phase IV oncology clinical trials on ClinicalTrials.gov starting between January 1, 2019, and December 31, 2023. Among these, we included trials with at least one US location, patient populations aged 18-65 or 65+, and a posted study protocol. We used descriptive statistics to capture prevalence of broad investigator discretion in eligibility criteria. We reviewed statements concerning discretionary eligibility criteria for text relating to psychiatric or cognitive disability, and we applied qualitative content analysis techniques to identify themes.
Results: Ninety-six trials met inclusion criteria for this study. Of these, 82 (85.4 %) of trials allowed broad investigator discretion to determine eligibility. Content analysis revealed concerns about participants' safety (i.e., posing undue risk to patients), potential difficulties adhering to study protocols (e.g., because of patients' physical, psychiatric, or social condition), perceived ability to obtain informed consent, and completing assessments of patients to determine results of interventions. All trials required informed consent.
Conclusions: Most oncology clinical trials allow investigators broad discretion in determining the eligibility of individuals to participate. These discretionary criteria may particularly target persons with psychiatric or cognitive disabilities, excluding them from participating in clinical trials. Further research should examine whether certain rationales for excluding these populations are appropriate.
期刊介绍：
Disability and Health Journal is a scientific, scholarly, and multidisciplinary journal for reporting original contributions that advance knowledge in disability and health. Topics may be related to global health, quality of life, and specific health conditions as they relate to disability. Such contributions include:
• Reports of empirical research on the characteristics of persons with disabilities, environment, health outcomes, and determinants of health
• Reports of empirical research on the Systematic or other evidence-based reviews and tightly conceived theoretical interpretations of research literature
• Reports of empirical research on the Evaluative research on new interventions, technologies, and programs
• Reports of empirical research on the Reports on issues or policies affecting the health and/or quality of life for persons with disabilities, using a scientific base.
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