Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals

IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Breast Pub Date : 2024-07-03 DOI:10.1016/j.breast.2024.103766
Bo Lan , Xuenan Peng , Fei Ma
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Abstract

Background

Clinical research competence determines the quality of clinical research and the reliability of research findings. We aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China.

Methods

This was a department-based cross-sectional study conducted in the form of electronic questionnaires on the Wenjuanxing platform from 7th August to 31st August 2023 among hospitals from the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers in China.

Results

A total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9 %) departments received good clinical practice (GCP) training. The steps of the approval process from research initiation to completion lasted 2–4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment.

Conclusions

Most departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation of clinical research, are required in future development.

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中国医院乳腺癌治疗科药物临床研究实施能力的问卷调查与分析。
背景:临床研究能力决定了临床研究的质量和研究结果的可靠性。我们旨在探讨中国乳腺癌治疗科室的临床研究实施能力:方法:这是一项以科室为单位的横断面研究,于 2023 年 8 月 7 日至 8 月 31 日在文娟星平台上对中国首批乳腺癌规范化诊疗质量控制试点中心的医院进行了电子问卷调查:最终共有来自 122 家医院的 127 份问卷被纳入分析。118个科室(92.9%)参与临床研究的医务人员接受了良好临床实践(GCP)培训。从研究启动到完成的审批过程持续了 2-4 周或更长的时间。大多数科室在过去一年中启动或参与了 2 个或更少的临床研究项目。在不同科室之间的差异中,肿瘤内科的资质情况和流程要好于肿瘤外科,启动和参与的临床研究数量也更多。对于需求和问题,大多数科室都有开展临床研究和接受专业培训的强烈意愿;在开展研究的过程中,最常见的问题是招募病人:结论:大多数科室普遍具备开展临床研究的能力。结论:大多数科室普遍具备开展临床研究的能力,但在实施效率、研究质量和患者招募方面仍需改进。在未来的发展中,需要进行专业培训和沟通,并推荐临床研究。
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来源期刊
Breast
Breast 医学-妇产科学
CiteScore
8.70
自引率
2.60%
发文量
165
审稿时长
59 days
期刊介绍: The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.
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