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GCP驻科药师在皮肤病专业药物临床试验管理中的实践路径与效果评价
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| 篇名： | GCP驻科药师在皮肤病专业药物临床试验管理中的实践路径与效果评价 |
| TITLE： | Practice pathway and effectiveness evaluation of GCP resident pharmacists in the management of dermatolo-gical drug clinical trials |
| 摘要： | 目的 探索药物临床试验机构办公室驻科药师（下称“GCP驻科药师”）在皮肤病专业药物临床试验管理中的实践路径并评价其效果。方法对我院GCP驻科药师参与皮肤病专业药物临床试验的实践路径进行介绍；回顾性分析2021－2024年我院皮肤病专业药物临床试验相关数据，对比皮肤病专业药物临床试验项目与其他专业项目的效率指标和质量指标。结果我院GCP驻科药师全程参与皮肤病专业药物临床试验的流程建设和优化，建立该专业药物临床试验专属质控体系，并优化该专业药物临床试验受试者入组加速策略。GCP驻科药师工作开展后，2021－2023年我院皮肤病专业药物临床试验项目数的复合年均增长率为69.56%。效率指标方面，皮肤病专业药物临床试验项目的立项等待时间为（12.31±4.99）d，显著短于其他专业项目的（19.68±6.09）d（P＜0.05）。质量指标方面，皮肤病专业药物临床试验项目入组率为75.71%（50.00%，114.48%），显著高于其他专业项目的51.00%（25.00%，174.17%）（P＜0.05）；首次质控问题条目数（[8.31±3.25）条vs.（11.68±4.49）条]、方案偏离次数[5.5（2.0，11.0）次vs.11.0（5.5，17.5）次]均显著少于其他专业项目（P＜0.05）。结论GCP驻科药师显著提升了皮肤病专业药物临床试验的整体效能，对确保药物临床试验可靠、真实，保障受试者权益、安全具有重要作用。 |
| ABSTRACT： | OBJECTIVE To explore the practice pathway and evaluate the effectiveness of the resident pharmacists stationed in the Drug Clinical Trial Institution Office （hereinafter referred to as the “GCP resident pharmacist”） in the management of dermatological drug clinical trials. METHODS The practical approach of GCP resident pharmacists participating in dermatological drug clinical trials at our hospital was introduced. A retrospective analysis was conducted on the data of dermatological drug clinical trials from 2021 to 2024， comparing efficiency and quality indicators between dermatological clinical trials and those of other specialties. RESULTS With the involvement of our hospital’s GCP resident pharmacists throughout, the process for dermatology drug clinical trials was constructed and optimized， a dedicated quality control system was established， and the acceleration strategy for subject enrollment was optimized. The number of dermatological drug clinical trials at our hospital showed a compound annual growth rate of 69.56% from 2021 to 2023. In terms of efficiency indicators， the approval waiting time for dermatological drug clinical trials was （12.31±4.99） days， which was significantly shorter than that of other specialties （[ 19.68±6.09） days， P＜0.05]. Regarding quality indicators， the enrollment rate for dermatological drug clinical trials was 75.71%（50.00%，114.48%）， which was significantly higher than that of other specialties [51.00%（25.00%，174.17%）， P＜0.05]. The numbers of first quality control issues （[ 8.31±3.25）items vs.（ 11.68±4.49）items] and protocol deviations [5.5（2.0，11.0）times vs. 11.0（5.5，17.5）times] were significantly lower than those of other specialties （P＜0.05）. CONCLUSIONS GCP resident pharmacists significantly enhance the overall efficiency of dermatological drug clinical trials， playing a crucial role in ensuring the reliability and authenticity of drug clinical trials， as well as safeguarding the rights and safety of trial subjects. |
| 期刊： | 2025年第36卷第20期 |
| 作者： | 王云龙；周立敏；章华；李全超 |
| AUTHORS： | WANG Yunlong，ZHOU Limin，ZHANG Hua，LI Quanchao |
| 关键字： | GCP驻科药师；药物临床试验；皮肤病专业；质量控制 |
| KEYWORDS： | GCP resident pharmacist； drug clinical trials； dermatological specialty； quality control |
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