Safety and compliance among newly qualified paramedics in a pre-hospital clinical trial of an investigational medicinal product: a post-hoc analysis of the PACKMaN randomised controlled trial.
Introduction: Pre-hospital research has unique challenges. Ambulance clinicians are required to enrol patients in research trials during emergency situations, often remote from the research team at time of recruitment. As newly qualified paramedics (NQPs) represent a significant and growing proporti...
| Published in: | British Paramedic Journal Vol. 10; no. 3; pp. 10 - 18 |
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| Main Authors: | , , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
College of Paramedics
Dec2025
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189630715&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189630715 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14784726 LFLE jtl: British Paramedic Journal issn: 14784726 maglogo: N pubinfo: dt: Dec2025 vid: 10 iid: 3 pid: 46865 pub: College of Paramedics artinfo: ui: 189630715 189630715 189630715 10.29045/14784726.2025.12.10.3.10 189630715 ppf: 10 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Safety and compliance among newly qualified paramedics in a pre-hospital clinical trial of an investigational medicinal product: a post-hoc analysis of the PACKMaN randomised controlled trial. aug: au: Rosser, Andy Gunson, Imogen Green, Zoe Lall, Ranjit Michelet, Felix Miller, Elisha Miller, Joshua Noordali, Hannah Perkins, Gavin Stanley, Owen Smyth, Michael affil: West Midlands Ambulance Service University NHS Foundation Trust sug: subj: Paramedics Occupational Safety Evaluation Professional Compliance Evaluation Clinical Trials Research Subject Recruitment Drugs, Investigational Therapeutic Use Ketamine Therapeutic Use Morphine Therapeutic Use Prehospital Care Analgesics Therapeutic Use Adverse Drug Event Epidemiology Protocols Human Male Female Adult Middle Age Post Hoc Analysis Confidence Intervals Odds Ratio Retrospective Design Fisher's Exact Test Chi Square Test Logistic Regression Descriptive Statistics England Funding Source Analgesia Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Introduction: Pre-hospital research has unique challenges. Ambulance clinicians are required to enrol patients in research trials during emergency situations, often remote from the research team at time of recruitment. As newly qualified paramedics (NQPs) represent a significant and growing proportion of ambulance clinicians, it is important to establish whether they can safely and effectively recruit patients to clinical trials. This article reports a post-hoc analysis of the PACKMaN trial, a large, double-blind randomised controlled trial of an investigational medicinal product of ketamine versus morphine in the pre-hospital setting. Methods: Adverse events (AEs) and serious adverse events (SAEs) experienced by patients recruited to the PACKMaN trial, as well as protocol non-compliances (NCs) experienced by paramedics during the trial, were retrospectively analysed. We compared recruitment, incidence and type of AE, as well as incidence of SAEs and NCs dichotomised by paramedic experience. Results: Of the 458 patients, 259 (56.6%) and 199 (43.4%) were recruited by experienced paramedics and NQPs, respectively. Incidence of AEs was similar regardless of experience: experienced paramedics reported 128/259 (49.8%) and NQPs reported 91/199 (45.7%) (OR 0.86 95% CI [0.60-1.25]). Incidence of SAEs were slightly increased in the NQP group (8/199 (4.0%)), compared to experienced paramedics (4/259 (1.5%)); however, this was not statistically significant (OR 2.67, 95% CI [0.66-9.00]). NC was similar in both groups: experienced paramedics 3/259 (1.2%) and NQPs 6/199 (3.0%) (OR 2.65 95% CI [0.66-10.74]). Conclusion: In a double-blind controlled trial of an investigational medicinal product, there was no statistical difference in the incidence of AEs or NCs between NQPs and experienced paramedics. NQPs made an important contribution to patient recruitment in this study, improving the generalisability. SAEs and NCs were rare, and patients received analgesics safely. There was no correlation between experience and AE likelihood, and no safety concerns identified arising from NQP participation. Our findings demonstrate that NQPs can safely recruit patients to clinical trials. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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