Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials

GUO Chunyan; ZHANG Yi; YANG Yuxin; LIANG Yuguang; DING Qian; WANG Qian; ZHANG Chengyue; SUN Yu; GUO Peng

doi:10.6039/j.issn.1001-0408.2026.09.17

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Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials

更新时间：2026-05-14

- Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
- ZHONGGUO YAOFANG Vol. 37, Issue 9, Pages: 1206-1210(2026)
- 作者机构：
  
  国家儿童医学中心/首都医科大学附属北京儿童医院临床研究中心，北京　100045
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.09.17
  CLC： R95
- Received：11 December 2025，
  
  Revised：2026-04-23，
  
  Accepted：23 April 2026，
  
  Published：15 May 2026
- 稿件说明：
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郭春彦,张怡,杨禹欣,等.根因分析结合知信行理论的药学服务降低儿童临床试验用药品方案违背发生率的效果评价 [J].中国药房,2026,37(09):1206-1210.

GUO Chunyan,ZHANG Yi,YANG Yuxin,et al.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials[J].ZHONGGUO YAOFANG,2026,37(09):1206-1210.
郭春彦,张怡,杨禹欣,等.根因分析结合知信行理论的药学服务降低儿童临床试验用药品方案违背发生率的效果评价 [J].中国药房,2026,37(09):1206-1210. DOI： 10.6039/j.issn.1001-0408.2026.09.17.

GUO Chunyan,ZHANG Yi,YANG Yuxin,et al.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials[J].ZHONGGUO YAOFANG,2026,37(09):1206-1210. DOI： 10.6039/j.issn.1001-0408.2026.09.17.

摘要

目的

探讨基于根因分析（RCA）问题导向与知信行（KAP）理论的药学服务在降低儿童临床试验用药品方案违背发生率方面的应用效果。

方法

选取我院2016年1月－2020年12月开展的69个药物临床试验项目的617名研究参与者作为对照组，2022年1月－2025年12月开展的72个药物临床试验项目的868名研究参与者作为观察组。通过对对照组发生的试验用药品方案违背进行RCA，确定方案违背类型及其发生原因。对照组开展药物临床试验常规药学服务；观察组在常规药学服务基础上，基于RCA发现的造成问题的根本原因，从知识、态度、行为3个层面实施精准药学服务。比较两组试验用药品方案违背的发生情况。

结果

观察组试验用药品方案违背总体发生率、轻微方案违背发生率、重大方案违背发生率均较对照组显著降低（

＜0.001）。两组发生的方案违背类型主要为漏用/少用/多用药品、给药时间不符合要求、未按要求调整药品剂量和违背方案合并用药/疫苗等。在试验用药品方案违背的责任主体方面，观察组中由研究参与者及其监护人以及研究人员、偶发性因素为责任主体导致的方案违背发生率均显著低于对照组（

＜0.001、

＝0.025）；而由申办者导致的方案违背发生率与对照组比较差异无统计学意义（

＞0.05）。

结论

由药师主导的基于RCA问题导向结合KAP理论的药学服务，可有效降低儿童临床试验用药品方案违背发生率，从而有效保障研究参与者的安全与权益。

Abstract

OBJECTIVE

To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials.

METHODS

A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups.

RESULTS

The total incidence of protocol violations of investigational medicinal products， as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the control group （

＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications， non-adherence to administration time， failure to adjust dosage as required， and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations， the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group （

＜0.001，

＝0.025）. However， there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups （

＞0.05）.

CONCLUSIONS

Pharmaceutical services led by pharmacists， based on problem-oriented RCA and combined with KAP theory， can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials， thereby safeguarding the safety and rights of study participants.

关键词

Keywords

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