The value and role of pharmacists in clinical trial drugs
药师在临床试验用药品管理中的价值与作用

摘要

目的 本次研究主要分析药师在临床试验用药品管理中的价值与作用。方法 研究时间段为2021年1月-2023年1月，研究数量为临床试验项目35个，项目随机分为实验组与对照组，实验组项目安排药师来专职管理临床试验用药品，对照组由常规医护人员兼职管理临床试验用药品，观察两组试验用药品的质量安全评分、试验结果的科学性评分以及试验用药品的管理成本。结果 实验组的试验用药品质量安全评分以及试验结果科学性评分均高于对照组，试验用药品管理成本低于对照组，p＜0.05。结论 临床试验用药品中安排药师专职管理，可为试验项目的质量安全与管理提供保障。

Abstract

Objective: This study mainly analyzes the value and role of pharmacists in clinical trial drugs. Method: The study period was from January 2021 to January 2023, with a total of 35 clinical trial projects. The projects were randomly divided into an experimental group and a control group. The experimental group was assigned a pharmacist to manage the clinical trial drugs full-time, while the control group was managed by routine medical staff part-time. The quality and safety scores of the trial drugs, the scientific scores of the trial results, and the management costs of the trial drugs were observed in both groups. Result: The quality and safety score of experimental drugs and the scientific score of experimental results in the experimental group were higher than those in the control group, and the management cost of experimental drugs was lower than that in the control group, with a p<0.05.
Conclusion  : The arrangement of pharmacists for dedicated management in clinical trial drugs can provide assurance for the quality, safety, and management of trial projects.