Improving the capture and reporting of adverse events in clinical trials of non-pharmacological interventions: learnings from the PaCCSC/CST membership.

Saleh Moussa, R; Power, J; Yenson, V; Fazekas, B; Marston, C; Hosie, A; Edwards, L; Disalvo, D; Brown, L; Gilmore, I; Stubbs, J; Cross, A; Fielding, S; Agar, MR

Improving the capture and reporting of adverse events in clinical trials of non-pharmacological interventions: learnings from the PaCCSC/CST membership.

Saleh Moussa, R Power, J Yenson, V

Fazekas, B Marston, C Hosie, A

Edwards, L

Disalvo, D Brown, L Gilmore, I Stubbs, J Cross, A Fielding, S Agar, MR

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Publisher:: Springer Nature
Publication Type:: Journal Article
Citation:: Trials, 2025, 26, (1), pp. 95
Issue Date:: 2025-03-18

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Field	Value	Language
dc.contributor.author	Saleh Moussa, R
dc.contributor.author	Power, J
dc.contributor.author	Yenson, V https://orcid.org/0000-0002-7112-0785
dc.contributor.author	Fazekas, B
dc.contributor.author	Marston, C
dc.contributor.author	Hosie, A https://orcid.org/0000-0003-1674-2124
dc.contributor.author	Edwards, L https://orcid.org/0000-0001-9951-237X
dc.contributor.author	Disalvo, D
dc.contributor.author	Brown, L
dc.contributor.author	Gilmore, I
dc.contributor.author	Stubbs, J
dc.contributor.author	Cross, A
dc.contributor.author	Fielding, S
dc.contributor.author	Agar, MR
dc.date.accessioned	2025-03-25T01:24:48Z
dc.date.available	2025-03-06
dc.date.available	2025-03-25T01:24:48Z
dc.date.issued	2025-03-18
dc.identifier.citation	Trials, 2025, 26, (1), pp. 95
dc.identifier.issn	1745-6215
dc.identifier.issn	1745-6215
dc.identifier.uri	http://hdl.handle.net/10453/186185
dc.description.abstract	BACKGROUND: Accurate capture and reporting of adverse events (AEs) in clinical trials is critical to understanding the potential harms of prospective interventions. Current AE-reporting frameworks are specifically constructed for pharmacological interventions and adaptation of these frameworks imparts the risk of excluding AEs unique to non-pharmacological interventions that have not yet been defined. As a result, clinical trials of non-pharmacological interventions seldom include a systematic method to capturing and reporting AEs, often using no method at all. These gaps make it likely that AEs in trials of non-pharmacological interventions are underreported, providing insufficient information about the safety of such interventions prior to their implementation in clinical practice. In addition, clinical trials focus primarily on participants receiving the intervention, with current AE-reporting frameworks not designed to capture potential harms to other personnel involved (i.e. family/carers, and clinical and research staff). A series of collaborative group discussions with consumers and interdisciplinary clinical trialists, and case study analyses were conducted to explore gaps in the capture and reporting of AEs specific to non-pharmacological trials, and their mitigation. MAIN BODY: Two case examples are provided. The first case example highlights that current methods are inadequate, resulting in inconsistencies in capturing AEs, influenced by the environmental context of the clinical trial. The second case example highlights the need for both systematic and simplified AE-reporting frameworks, particularly for clinical trials conducted in medically complex populations where participants may be at high risk of experiencing AEs. We recommend future trials of non-pharmacological interventions adopt a four-step framework that incorporates: (1) enhanced trial protocol development to define the participant, environmental context in which the intervention is taking place and identify other personnel involved; (2) pre-specify anticipated AEs in trial protocol; (3) selection of the most appropriate measurement system to define, report and grade AEs; and (4) develop corrective and preventative action plans. CONCLUSION: We provide recommendations for an AE-reporting framework for future trials that encompass risks unique to non-pharmacological interventions and all individuals involved. By focusing on these directions, we can streamline the process of capturing and reporting AEs and contribute to more impactful and sustainable outcomes.
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Nature
dc.relation	Cancer Australia
dc.relation.ispartof	Trials
dc.relation.isbasedon	10.1186/s13063-025-08801-1
dc.rights	info:eu-repo/semantics/restrictedAccess
dc.subject	1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
dc.subject.classification	Cardiovascular System & Hematology
dc.subject.classification	General & Internal Medicine
dc.subject.classification	3202 Clinical sciences
dc.subject.classification	4202 Epidemiology
dc.subject.classification	4203 Health services and systems
dc.subject.mesh	Humans
dc.subject.mesh	Clinical Trials as Topic
dc.subject.mesh	Research Design
dc.subject.mesh	Humans
dc.subject.mesh	Research Design
dc.subject.mesh	Clinical Trials as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Clinical Trials as Topic
dc.subject.mesh	Research Design
dc.title	Improving the capture and reporting of adverse events in clinical trials of non-pharmacological interventions: learnings from the PaCCSC/CST membership.
dc.type	Journal Article
utslib.citation.volume	26
utslib.location.activity	England
utslib.for	1102 Cardiorespiratory Medicine and Haematology
utslib.for	1103 Clinical Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)
pubs.organisational-group	University of Technology Sydney/UTS Groups/INSIGHT: Institute for Innovative Solutions for Wellbeing and Health
utslib.copyright.status	recently_added	*
dc.date.updated	2025-03-25T01:24:46Z
pubs.issue	1
pubs.publication-status	Published online
pubs.volume	26
utslib.citation.issue	1

Abstract:

BACKGROUND: Accurate capture and reporting of adverse events (AEs) in clinical trials is critical to understanding the potential harms of prospective interventions. Current AE-reporting frameworks are specifically constructed for pharmacological interventions and adaptation of these frameworks imparts the risk of excluding AEs unique to non-pharmacological interventions that have not yet been defined. As a result, clinical trials of non-pharmacological interventions seldom include a systematic method to capturing and reporting AEs, often using no method at all. These gaps make it likely that AEs in trials of non-pharmacological interventions are underreported, providing insufficient information about the safety of such interventions prior to their implementation in clinical practice. In addition, clinical trials focus primarily on participants receiving the intervention, with current AE-reporting frameworks not designed to capture potential harms to other personnel involved (i.e. family/carers, and clinical and research staff). A series of collaborative group discussions with consumers and interdisciplinary clinical trialists, and case study analyses were conducted to explore gaps in the capture and reporting of AEs specific to non-pharmacological trials, and their mitigation. MAIN BODY: Two case examples are provided. The first case example highlights that current methods are inadequate, resulting in inconsistencies in capturing AEs, influenced by the environmental context of the clinical trial. The second case example highlights the need for both systematic and simplified AE-reporting frameworks, particularly for clinical trials conducted in medically complex populations where participants may be at high risk of experiencing AEs. We recommend future trials of non-pharmacological interventions adopt a four-step framework that incorporates: (1) enhanced trial protocol development to define the participant, environmental context in which the intervention is taking place and identify other personnel involved; (2) pre-specify anticipated AEs in trial protocol; (3) selection of the most appropriate measurement system to define, report and grade AEs; and (4) develop corrective and preventative action plans. CONCLUSION: We provide recommendations for an AE-reporting framework for future trials that encompass risks unique to non-pharmacological interventions and all individuals involved. By focusing on these directions, we can streamline the process of capturing and reporting AEs and contribute to more impactful and sustainable outcomes.

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http://hdl.handle.net/10453/186185