医院临床试验培训现状分析及优化探索

Analysis of Current Status of Clinical Trial Training in Hospitals and Optimization Suggestions

目的:分析医院临床试验培训现状,发现存在的问题,提出改进措施。方法:通过查阅档案和发放调查问卷,对102名临床试验研究人员的培训情况进行分析。结果:培训时间安排不合理(53.9%)、培训内容实用性不高(49.0%)、针对性不强(45.1%)、培训方式单一(43.1%)是临床试验培训中较为突出的问题。大部分研究人员参加培训的目的是为了提高临床试验的质量。临床试验研究人员普遍愿意参与非休息时间的培训,影响临床试验培训积极性的因素中占比最高的是没有时间接受培训(60.8%)。研究人员表现出高熟练度的实施、低掌握度的专业知识。76.5%的研究人员期望线上培训的比重在21%以上,新媒体培训受欢迎度很高。29.4%的研究人员能一年参加2次以上培训,从未参加过培训的占4.9%。人口学差异对临床试验培训动机和需求没有明显影响,而人员学历和年龄对培训意愿的影响有统计学差异,临床试验培训效果和满意度在人员学历上均存在统计学差异。结论:需要优化培训模式、内容,建立健全培训体系,进一步提高培训的效率和成效。

Objective:To analyze current status of clinical trial training of Shanghai Chest Hospital,so as to find existing problems and put forward solutions.Methods:Through file review and questionnaire survey,clinical trial training of 102 researchers was analyzed.Results:Main problems in clinical trial training included poor scheduling(53.9%),low applicability of training content(49.0%),lack of relevance(45.1%),and monotonous training method(43.1%).The purpose of most researchers participating in the training was to improve the quality of clinical trials.They were generally willing to participate in training during work hours,and time was the biggest factor affecting their enthusiasm for participation(60.8%).Researchers showed high proficiency in conducting clinical trials and low mastery of trial methods.76.5%of researchers expected online training to account for more than 21%,and training using new media enjoyed high popularity.29.4%of researchers were able to participate in more than two training a year,but 4%had never participated in any training.Demographic differences had no significant impact on training motivation and demand,while educational background and age showed a statistical significant difference in researchers’willingness to participate in training.Educational background also had statistically difference in training effects and satisfaction.Conclusion:It is necessary to optimize the training design and contents,establish a sound training system,and further improve the efficiency and effectiveness of training.