Felecity Estrella, Julia Lewin, Anneliese Schuessler
{"title":"在一期临床中建立临床IDS药剂师的角色。","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":"{\"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}","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}
Establishing the clinical IDS pharmacist role in a phase 1 clinic.
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.
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...