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Background <p>Investigator-initiated clinical trials have flourished in China. However, research on stakeholders’ perceptions and management capacity of investigator-initiated clinical trials, which are crucial for optimizing resource utilization, timely identifying barriers affecting high-quality Investigator-initiated clinical trials output, and providing evidence for establishing, improving, and evaluating the quality management system for Investigator-initiated clinical trials, is rare. Our objective is to assess the perception of the standardized quality management of Investigator-initiated clinical trials among stakeholders at different levels of healthcare institutions.</p> Methods <p>We conducted a cross-sectional study using an electronic survey designed using REDCap conducted between June and September 2024 in Healthcare institutions of various levels in Beijing, China. Hospital level, education level, years in research, familiarity, distinction ability, medical personnel, research administrators, methodologists, and other personnel were investigated as potential influencing factors. The primary outcomes were the total number of correct answers and weighted correct rates for each domain and all six domains.</p> Results <p>A total of 717 individuals participated in the study. The distribution of total correct answers and weighted correct rates across all domains was 20.0 (15.0–23.0) and 0.8 (0.6–0.9), respectively. Participants from higher-level hospitals, those with higher education levels, greater familiarity, and higher distinction ability, and administrators performed significantly better in terms of the total number of correct answers and weighted correct rates across all domains.</p> Conclusions <p>The stakeholders performed well overall. However, much room for improvement still exists. Hospital level, education level, familiarity, distinction ability, and the role of research administrators can influence the overall performance of stakeholders. Establishing, improving, and evaluating a quality management system for Investigator-initiated clinical trials in China is crucial.</p> Trial registration <p>Not applicable.</p>

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Stakeholder perception of quality management of investigator-initiated clinical trials

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月30日

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  • Wenqiang Li,
  • Kailibinuer Ailimu,
  • Nanxi Jia,
  • Hongling Chu,
  • Yiming Zhao,
  • Liyuan Tao,
  • Siyan Zhan,
  • Lin Zeng

摘要

Background

Investigator-initiated clinical trials have flourished in China. However, research on stakeholders’ perceptions and management capacity of investigator-initiated clinical trials, which are crucial for optimizing resource utilization, timely identifying barriers affecting high-quality Investigator-initiated clinical trials output, and providing evidence for establishing, improving, and evaluating the quality management system for Investigator-initiated clinical trials, is rare. Our objective is to assess the perception of the standardized quality management of Investigator-initiated clinical trials among stakeholders at different levels of healthcare institutions.

Methods

We conducted a cross-sectional study using an electronic survey designed using REDCap conducted between June and September 2024 in Healthcare institutions of various levels in Beijing, China. Hospital level, education level, years in research, familiarity, distinction ability, medical personnel, research administrators, methodologists, and other personnel were investigated as potential influencing factors. The primary outcomes were the total number of correct answers and weighted correct rates for each domain and all six domains.

Results

A total of 717 individuals participated in the study. The distribution of total correct answers and weighted correct rates across all domains was 20.0 (15.0–23.0) and 0.8 (0.6–0.9), respectively. Participants from higher-level hospitals, those with higher education levels, greater familiarity, and higher distinction ability, and administrators performed significantly better in terms of the total number of correct answers and weighted correct rates across all domains.

Conclusions

The stakeholders performed well overall. However, much room for improvement still exists. Hospital level, education level, familiarity, distinction ability, and the role of research administrators can influence the overall performance of stakeholders. Establishing, improving, and evaluating a quality management system for Investigator-initiated clinical trials in China is crucial.

Trial registration

Not applicable.