Zhongguo quanke yixue (Dec 2022)
Paths to Cultivate Practical Sci-tech Innovation Talents in District (County) Hospitals: a Case Study of the Treatment of Clinical Trial Protocol Violations
Abstract
Background District (county) hospitals are leading institutions delivering primary health services, which are responsible for providing local healthcare services, teaching and training medical talents, and carrying out medical research. However, their high-quality development has been restricted by limited scientific and technological innovation capability. Objective To review the studies published in recent 10 years on the treatment of clinical trial protocol violations, providing evidence for exploring paths to solve such violations during the cultivation of practical sci-tech innovation talents in district (county) hospitals. Methods In January 2022, studies on clinical trial protocol violations published between January 1, 2010 and December 31, 2021 were searched in databases of CNKI, WanFang Data, CQVIP, Baidu Wenku, PubMed, Medline, the Cochrane Library, Embase, and ClinicalKey using "临床试验" "医学伦理" "违规问题" as search terms in Chinese, and "Clinical Trial" "Ethical Issues" "Clinical Trial" "Ethical Problems" as terms in English. Clinical trial protocol violations were extracted and classified according to the nature of the violations. Systematic clustering algorithm was used to implement cluster analysis of the violations according to inter-cluster connection. Root cause analysis was used to explore the root causes of the violations. Results The violations were divided into five classes (covering 27 subclasses) , and the first three were human subject protection (n=42, 33.6%) , clinical trial protocol (n=33, 26.4%) and informed consent (n=31, 24.8%) . Cluster analysis showed that the 125 violations could be grouped into two categories: authenticity (academic fraud) and compliance (violations) . The root causes of academic fraud and violations were as follows: insufficient research capability and low level of ethical knowledge in individuals or institutions; unsatisfactory punishment on individuals or institutions committing academic fraud; inadequate supervision of the sci-tech innovation achievements assessment and the ethical review system. Conclusion To solve academic fraud and ethical violations in trials, it is suggested to provide sci-tech innovation talents with practical ideology education on medical ethics that they should abide by in carrying out clinical trials by hospitals and colleges.
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