ArticlePsycho-oncology2025
Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols.
Article in Psycho-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses 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
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Could Subjective Cognitive Complaints Give the Facts of Objective Cognitive Impairments in Non-Central Nervous System Cancer? A Systematic Review.Brain and behavior · 2026Pooled it
- Vulnerability in research ethics: A systematic review of policy guidelines and documents.PloS one · 2025Pooled it
- A Multidisciplinary Model for Risk Management and Detection of Ageist Bias in Healthcare Systems in the Era of Artificial Intelligence.Healthcare (Basel, Switzerland) · 2026Article
- Personalized Treatment Recommendation System in Head and Neck Cancer Using Survival Analysis and Deep Learning.Healthcare (Basel, Switzerland) · 2026Article
- Adherence to Breast, Cervical, and Colorectal Cancer Screening Among Women in Spain: Evidence from the 2023 Spanish Health Survey.Healthcare (Basel, Switzerland) · 2026Article
- Introducing the Metaphorical Anchor Model: A Mixed-Methods Study of Cognitive Metaphor Use in Palliative Care.Behavioral sciences (Basel, Switzerland) · 2026Article
- Supporting Parental Decision-Making After Life-Limiting Fetal Diagnoses: The Role of Perinatal Hospice and the NOVA-L Decision Support System.Healthcare (Basel, Switzerland) · 2026Article
- Modern Clinical Trials: Seamless Designs and Master Protocols.Cancer medicine · 2026Review
- Efficacy of Technology-Based Cognitive Rehabilitation Tools for Cancer-Related Cognitive Impairment in Non-CNS Cancer Patients: A Systematic Review.Healthcare (Basel, Switzerland) · 2026Review
- Exploring AI-assisted design of executive function rehabilitation programs for individuals with ADHD: a mixed-methods evaluation of prompts and chatgpt outputs.BMC psychology · 2025Article
- Clinical Decision Support Systems and Artificial Intelligence in ADHD Assessment and Rehabilitation: Opportunities and Challenges for Technology-Assisted Care.Healthcare (Basel, Switzerland) · 2025Article
- Emotional Responses in Clinical Ethics Consultation Decision-Making: An Exploratory Study.Behavioral sciences (Basel, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundCancer clinical trials often employ exclusion criteria that can impact vulnerable populations, particularly individuals with psychological, psychiatric, or neurological conditions.
aimsThis study aimed to analyze the prevalence and nature of exclusion criteria in clinical trials for prostate, breast, and lung cancers.
methodsThe EU Clinical Trials Register identified 51 protocols uploaded between 2022 and 2024. Thematic content analysis categorized exclusion criteria, and the justifications provided, while frequency analysis quantified their prevalence.
resultsAfter excluding five protocols (two non-English and three inaccessible), the final dataset comprised 46 protocols: 13 for prostate cancer (22.8%), 24 for breast cancer (42.1%), and 9 for lung cancer (15.8%). Exclusion criteria targeting vulnerable populations were present in 78.3% of protocols, categorized into five themes: psychiatric conditions (24.6%), neurological conditions (22.8%), other psychological conditions (22.8%), legal/guardianship status (5.3%), and unspecified conditions (24.6%). Compliance concerns (39.1%) were the most common justification, followed by informed consent challenges (32.6%), safety risks (13%), drug interference (10.9%), and not in the best interest (4.3%). Notably, 29.1% of protocols lacked justification for exclusions, raising ethical and transparency concerns.
conclusionsThe exclusion of vulnerable populations may limit the inclusivity and generalizability of cancer research. Heuristic biases and systemic practices can potentially influence this. Exploring the role of these factors and considering adaptive trial designs, along with providing detailed justifications for exclusion criteria, could support more equitable and representative clinical research.
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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.