Establishing the clinical IDS pharmacist role in a phase 1 clinic.

IF 0.9 4区 医学 Q4 ONCOLOGY
Felecity Estrella, Julia Lewin, Anneliese Schuessler
{"title":"Establishing the clinical IDS pharmacist role in a phase 1 clinic.","authors":"Felecity Estrella, Julia Lewin, Anneliese Schuessler","doi":"10.1177/10781552251376302","DOIUrl":null,"url":null,"abstract":"<p><p>BackgroundPhase 1 oncology clinical trials are complex and prioritize patient safety. Clinical pharmacists-experts in pharmacotherapy and patient-centered care-can enhance these trials by managing drug regimens and interactions. Despite demonstrated benefits, their integration into trial teams remains inconsistent. To address this, the Fred Hutch Phase 1 Clinical Trials Program embedded a clinical Investigational Drug Services (IDS) pharmacist into the clinic. This study assessed pharmacist utilization, intervention types, time spent, and inquiry sources.MethodsA retrospective review compared a pilot phase (Apr 2021-Apr 2022) and a follow-up (Apr-Sept 2023). Intervention type, frequency, duration, and communication modality were descriptively analyzed.ResultsDuring the pilot phase, 311 interventions were documented, primarily related to concomitant medication reviews (77%) and drug information (16%). In the 6-month follow-up period, 302 interventions were recorded, demonstrating an increased reliance on pharmacist services. Concomitant medication reviews remained high at 83%, indicating the pharmacist's critical role in medication management. Total intervention time was 93 h (pilot) compared to 72 h (follow-up), with a consistent median time per intervention. Over 85% of inquiries originated from study coordinators and nurses. The adoption of digital communication tools supported streamlined workflows and timely responses, aligning with broader clinic operational enhancements.ConclusionsThe integration of clinical IDS pharmacists enhanced the management of phase 1 trials while maintaining high safety and compliance standards. This study demonstrates the important contributions of pharmacists in supporting early-phase clinical trial research and highlights opportunities for expanding their role to meet growing trial complexities.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376302"},"PeriodicalIF":0.9000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Oncology Pharmacy Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10781552251376302","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

BackgroundPhase 1 oncology clinical trials are complex and prioritize patient safety. Clinical pharmacists-experts in pharmacotherapy and patient-centered care-can enhance these trials by managing drug regimens and interactions. Despite demonstrated benefits, their integration into trial teams remains inconsistent. To address this, the Fred Hutch Phase 1 Clinical Trials Program embedded a clinical Investigational Drug Services (IDS) pharmacist into the clinic. This study assessed pharmacist utilization, intervention types, time spent, and inquiry sources.MethodsA retrospective review compared a pilot phase (Apr 2021-Apr 2022) and a follow-up (Apr-Sept 2023). Intervention type, frequency, duration, and communication modality were descriptively analyzed.ResultsDuring the pilot phase, 311 interventions were documented, primarily related to concomitant medication reviews (77%) and drug information (16%). In the 6-month follow-up period, 302 interventions were recorded, demonstrating an increased reliance on pharmacist services. Concomitant medication reviews remained high at 83%, indicating the pharmacist's critical role in medication management. Total intervention time was 93 h (pilot) compared to 72 h (follow-up), with a consistent median time per intervention. Over 85% of inquiries originated from study coordinators and nurses. The adoption of digital communication tools supported streamlined workflows and timely responses, aligning with broader clinic operational enhancements.ConclusionsThe integration of clinical IDS pharmacists enhanced the management of phase 1 trials while maintaining high safety and compliance standards. This study demonstrates the important contributions of pharmacists in supporting early-phase clinical trial research and highlights opportunities for expanding their role to meet growing trial complexities.

在一期临床中建立临床IDS药剂师的角色。
1期肿瘤临床试验是复杂的,并且优先考虑患者的安全性。临床药理学家——药物治疗和以病人为中心的护理方面的专家——可以通过管理药物方案和相互作用来加强这些试验。尽管证明了它们的好处,但它们与试验团队的集成仍然不一致。为了解决这个问题,Fred Hutch一期临床试验项目在临床研究药物服务(IDS)药剂师中嵌入了一名药剂师。本研究评估了药剂师的使用情况、干预类型、花费的时间和询问来源。方法一项回顾性评价比较了试点阶段(2021年4月- 2022年4月)和随访阶段(2023年4月- 9月)。对干预类型、频率、持续时间和沟通方式进行描述性分析。结果在试点阶段,记录了311项干预措施,主要与伴随用药回顾(77%)和药物信息(16%)有关。在6个月的随访期间,记录了302项干预措施,表明对药剂师服务的依赖程度有所增加。伴随用药复查保持在83%的高位,表明药师在用药管理中的关键作用。总干预时间为93小时(先导),而72小时(随访),每次干预的中位数时间一致。超过85%的询问来自研究协调员和护士。采用数字通信工具支持简化工作流程和及时响应,与更广泛的诊所业务改进相一致。结论IDS临床药师的整合加强了i期试验的管理,同时保持了较高的安全性和依从性标准。本研究证明了药师在支持早期临床试验研究方面的重要贡献,并强调了扩大其作用以满足日益增长的试验复杂性的机会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信