Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation.
Objectives: Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the r...
| Publicado en: | Journal of Patient Safety Vol. 19; no. 7; pp. 460 - 465 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Lippincott Williams & Wilkins
Oct2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=172432373&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 172432373 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15498417 1WYD jtl: Journal of Patient Safety issn: 15498417 maglogo: N pubinfo: dt: Oct2023 vid: 19 iid: 7 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 172432373 172432373 172432373 10.1097/pts.0000000000001154 172432373 ppf: 460 ppct: 5 formats: tig: atl: Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. aug: au: Loo, Vivian C. Sarah Kim Johnson, Lisa M. Kay, Howard Annie Yi Jason Chen Asmar-Abdien, Lisa O. affil: Department of Protocol Content Administration. sug: subj: Medication Errors Prevention and Control Patient Safety Methods Oncology Clinical Trials Implementation Science Human Content Analysis Diagnostic Errors Treatment Errors Adverse Drug Event Risk Assessment ab: Objectives: Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. Methods: A dedicated group of centralized clinical content specialists reviewed trial documents, including the protocol, laboratory manual, and pharmacy/cellular therapy manual, and collected intervention data over a 1-year period. Each trial was categorized by study phase and sponsor type, and multiple interventions could be identified per trial. Interventions were deemed administrative or PPSIs, with PPSIs further subcategorized as medication, laboratory, procedure related, or other. Results: Of 585 clinical trials reviewed, 269 (46%) required intervention (s). Among 1001 interventions, 171 (17.1%) were PPSIs. Most PPSIs were medication related (45.6%), with drug dosing interventions most frequently identified (53.8%). Phase 1 trials had the highest proportion of PPSIs (0.35:1) and administrative interventions (2:1) per trial compared with all other phases. Investigator-initiated trials saw the highest proportion of PPSIs per trial (0.44:1) of all sponsor types. Conclusions: This study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilization of a centralized team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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