Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols.
Saved in:
| Title: | Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols. |
|---|---|
| Authors: | Dahò, Margherita (AUTHOR), Coppini, Veronica (AUTHOR), Ferrari, Maria Vittoria (AUTHOR), Ferraris, Giulia (AUTHOR), Sanchini, Virginia (AUTHOR), Monzani, Dario (AUTHOR), Grasso, Roberto (AUTHOR), Agnello, Chiara (AUTHOR), Badalamenti, Giuseppe (AUTHOR), Algeri, Laura (AUTHOR), Pravettoni, Gabriella (AUTHOR) |
| Source: | Psycho-Oncology. May2025, Vol. 34 Issue 5, p1-8. 8p. |
| Subjects: | Neurological disorders, Mental illness, Research protocols, Poor communities, Ethical problems, Clinical trials, Diversity & inclusion policies, Inclusion (Disability rights) |
| Abstract: | Background: Cancer clinical trials often employ exclusion criteria that can impact vulnerable populations, particularly individuals with psychological, psychiatric, or neurological conditions. Aims: This study aimed to analyze the prevalence and nature of exclusion criteria in clinical trials for prostate, breast, and lung cancers. Methods: The 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. Results: After 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. Conclusions: The 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Psycho-Oncology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
|
Full text is not displayed to guests.
Login for full access.
|
|
| FullText | Links: – Type: pdflink Text: Availability: 1 |
|---|---|
| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 185453333 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
| IllustrationInfo | |
| Items | – Name: Title Label: Title Group: Ti Data: Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Dahò%2C+Margherita%22">Dahò, Margherita</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Coppini%2C+Veronica%22">Coppini, Veronica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferrari%2C+Maria+Vittoria%22">Ferrari, Maria Vittoria</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferraris%2C+Giulia%22">Ferraris, Giulia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sanchini%2C+Virginia%22">Sanchini, Virginia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Monzani%2C+Dario%22">Monzani, Dario</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grasso%2C+Roberto%22">Grasso, Roberto</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Agnello%2C+Chiara%22">Agnello, Chiara</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Badalamenti%2C+Giuseppe%22">Badalamenti, Giuseppe</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Algeri%2C+Laura%22">Algeri, Laura</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pravettoni%2C+Gabriella%22">Pravettoni, Gabriella</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Psycho-Oncology%22">Psycho-Oncology</searchLink>. May2025, Vol. 34 Issue 5, p1-8. 8p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Neurological+disorders%22">Neurological disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+illness%22">Mental illness</searchLink><br /><searchLink fieldCode="DE" term="%22Research+protocols%22">Research protocols</searchLink><br /><searchLink fieldCode="DE" term="%22Poor+communities%22">Poor communities</searchLink><br /><searchLink fieldCode="DE" term="%22Ethical+problems%22">Ethical problems</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Diversity+%26+inclusion+policies%22">Diversity & inclusion policies</searchLink><br /><searchLink fieldCode="DE" term="%22Inclusion+%28Disability+rights%29%22">Inclusion (Disability rights)</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Background: Cancer clinical trials often employ exclusion criteria that can impact vulnerable populations, particularly individuals with psychological, psychiatric, or neurological conditions. Aims: This study aimed to analyze the prevalence and nature of exclusion criteria in clinical trials for prostate, breast, and lung cancers. Methods: The 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. Results: After 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. Conclusions: The 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Psycho-Oncology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=185453333 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/pon.70182 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 8 StartPage: 1 Subjects: – SubjectFull: Neurological disorders Type: general – SubjectFull: Mental illness Type: general – SubjectFull: Research protocols Type: general – SubjectFull: Poor communities Type: general – SubjectFull: Ethical problems Type: general – SubjectFull: Clinical trials Type: general – SubjectFull: Diversity & inclusion policies Type: general – SubjectFull: Inclusion (Disability rights) Type: general Titles: – TitleFull: Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Dahò, Margherita – PersonEntity: Name: NameFull: Coppini, Veronica – PersonEntity: Name: NameFull: Ferrari, Maria Vittoria – PersonEntity: Name: NameFull: Ferraris, Giulia – PersonEntity: Name: NameFull: Sanchini, Virginia – PersonEntity: Name: NameFull: Monzani, Dario – PersonEntity: Name: NameFull: Grasso, Roberto – PersonEntity: Name: NameFull: Agnello, Chiara – PersonEntity: Name: NameFull: Badalamenti, Giuseppe – PersonEntity: Name: NameFull: Algeri, Laura – PersonEntity: Name: NameFull: Pravettoni, Gabriella IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 05 Text: May2025 Type: published Y: 2025 Identifiers: – Type: issn-print Value: 10579249 Numbering: – Type: volume Value: 34 – Type: issue Value: 5 Titles: – TitleFull: Psycho-Oncology Type: main |
| ResultId | 1 |
