An INTERACT3-based survey of neurosurgeons’ preferences for investigator-initiated trails_West China Medical Journal

Authors：

LI Qi ¹ , GAO Zijing ² , TENG Bang ² ,  HU Xin ²

1. Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
2. Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

HU Xin, Email: huxingxxy@gmail.com

Keywords：

Neurosurgeon; clinical research; questionnaire

DOI：

10.7507/1002-0179.202310071

Video：

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Objective To understand the current status of the preferences and opinions on the investigator-initiated trails (IIT) of the neurosurgeons participating in INTERACT3 in China, as well as the design preference for IIT projects, and to provide a basis for the design and organization of multi-center clinical studies in the future. Methods Neurosurgeons with different seniority and professional titles from 89 domestic research institutions participating in the INTERACT3 project were collected from September to October 2023. The questionnaires were collected by questionnaire star. Results A total of 56 valid questionnaires were collected from 29 units. Among the 56 respondents, 52 neurosurgeons (92.86%) were from teaching hospitals and 45 (80.36%) were from grade A tertiary hospitals. 30 neurosurgeons (53.57%) had experience in conducting various clinical studies, and 55 neurosurgeons (98.21%) had experience in participating in various clinical studies. The main purposes of presiding over or participating in clinical research focused on “accumulating relevant experience and preparing for future projects” and “standardizing clinical diagnosis and treatment”, which were 89.29% and 83.93%. Respectively, regarding the way the case report form completing, respondents preferred to use electronic data collection systems (83.93%). Conclusions The purpose of the neurosurgeons interviewed to host or participate in clinical research is mainly to assist clinical and scientific research. Economic reasons have little impact on whether to participate in clinical research. The rationality and ease of operation of the trail design are the keys to attracting respondents to participate in clinical researches, and the level of remuneration has little impact on the decision-making of the respondents. The safety of clinical studies and the difficulty of enrolling subjects are the key factors that hinder respondents’ participation in clinical studies.

Citation： LI Qi, GAO Zijing, TENG Bang, HU Xin. An INTERACT3-based survey of neurosurgeons’ preferences for investigator-initiated trails. West China Medical Journal, 2024, 39(5): 749-753. doi: 10.7507/1002-0179.202310071 Copy

1.	陆俊, 郑华龙, 许斌斌, 等. 对高质量前瞻性临床研究的认识与体会. 中国实用外科杂志, 2022, 42(4): 388-390.
2.	Ma L, Hu X, Song L, et al. The third intensive care bundle with blood pressure reduction in acute cerebral haemorrhage trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet, 2023, 402(10395): 27-40.
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5.	苏毓, 覃开舟, 许健, 等. 研究者发起的临床研究中电子数据采集系统的研究与实践. 中国现代医生, 2022, 60(34): 111-115.
6.	朱琪, 李梦诗, 金晶, 等. 新时期研究者发起的临床研究管理实践. 中华医学科研管理杂志, 2023, 36(4): 308-311.
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9.	高深甚, 李俊, 刘文豪. 医院在研究者发起的临床研究中的作用. 中国研究型医院, 2022, 9(4): 60-63.
10.	汪朝晖, 杨忠奇, 杜彦萍, 等. 谈药物临床试验中研究者依从性的管理. 江西中医药大学学报, 2009, 21(1): 20-22.
11.	巩福莲, 王晓玲, 梁宇光. 中国医疗机构内研究者发起的临床研究之管理要素分析. 现代医院, 2022, 22(8): 1149-1152, 1156.
12.	储召群, 张语馨, 姜梅玲, 等. 某医院研究者发起的临床研究现状与发展对策分析. 药物流行病学, 2022, 31(12): 850-853.
13.	严小芳, 孙颖, 张丽萍, 等. 研究者发起的临床研究分中心研究者依从性管理探讨. 中国新药与临床杂志, 2022, 41(11): 659-664.
14.	杨志敏, 耿莹, 高晨燕. 对研究者发起的临床研究的认识和思考. 中国新药杂志, 2014, 23(4): 384-390.
15.	胡婷婷, 吕文文, 沈恩璐, 等. 研究者发起的临床研究常见质量问题和对策分析. 中国新药与临床杂志, 2011, 40(11): 746-749.
16.	朱梓嫣, 陈贞, 张绿, 等. 研究者发起的临床研究成果管理探索与思考. 中国研究型医院, 2023, 10(2): 1-5.

1. 陆俊, 郑华龙, 许斌斌, 等. 对高质量前瞻性临床研究的认识与体会. 中国实用外科杂志, 2022, 42(4): 388-390.
2. Ma L, Hu X, Song L, et al. The third intensive care bundle with blood pressure reduction in acute cerebral haemorrhage trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet, 2023, 402(10395): 27-40.
3. Ouyang M, Anderson CS, Song L, et al. Process evaluation of an implementation trial: design, rationale, and early lessons learnt from an international cluster clinical trial in intracerebral hemorrhage. Front Med (Lausanne). 2022, 9: 813749.
4. 赵继宗. 临床神经科学发展面临的新机遇与挑战. 中华医学杂志, 2018, 98(29): 2297-2298.
5. 苏毓, 覃开舟, 许健, 等. 研究者发起的临床研究中电子数据采集系统的研究与实践. 中国现代医生, 2022, 60(34): 111-115.
6. 朱琪, 李梦诗, 金晶, 等. 新时期研究者发起的临床研究管理实践. 中华医学科研管理杂志, 2023, 36(4): 308-311.
7. 彭树涛, 仇晓春. 上海交通大学医学院临床试验研究现状分析. 上海交通大学学报 (医学版), 2022, 42(8): 971-979.
8. 彭晓霞. 把握临床研究创新要点提高临床研究创新水平. 中华医学杂志, 2020, 100(44): 3479-3483.
9. 高深甚, 李俊, 刘文豪. 医院在研究者发起的临床研究中的作用. 中国研究型医院, 2022, 9(4): 60-63.
10. 汪朝晖, 杨忠奇, 杜彦萍, 等. 谈药物临床试验中研究者依从性的管理. 江西中医药大学学报, 2009, 21(1): 20-22.
11. 巩福莲, 王晓玲, 梁宇光. 中国医疗机构内研究者发起的临床研究之管理要素分析. 现代医院, 2022, 22(8): 1149-1152, 1156.
12. 储召群, 张语馨, 姜梅玲, 等. 某医院研究者发起的临床研究现状与发展对策分析. 药物流行病学, 2022, 31(12): 850-853.
13. 严小芳, 孙颖, 张丽萍, 等. 研究者发起的临床研究分中心研究者依从性管理探讨. 中国新药与临床杂志, 2022, 41(11): 659-664.
14. 杨志敏, 耿莹, 高晨燕. 对研究者发起的临床研究的认识和思考. 中国新药杂志, 2014, 23(4): 384-390.
15. 胡婷婷, 吕文文, 沈恩璐, 等. 研究者发起的临床研究常见质量问题和对策分析. 中国新药与临床杂志, 2011, 40(11): 746-749.
16. 朱梓嫣, 陈贞, 张绿, 等. 研究者发起的临床研究成果管理探索与思考. 中国研究型医院, 2023, 10(2): 1-5.

West China Medical Journal

An INTERACT3-based survey of neurosurgeons’ preferences for investigator-initiated trails

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