Bioethics Research Center, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Clin Trials. 2020 Apr;17(2):166-175. doi: 10.1177/1740774519893301. Epub 2020 Jan 27.
Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice.
We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation.
During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order).
The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.
良好临床实践是设计和进行临床试验的国际标准，旨在确保伦理和科学的完整性。最近，美国国立卫生研究院的政策要求所有参与美国国立卫生研究院资助的临床试验的研究人员和工作人员接受良好临床实践培训，但良好临床实践培训的方法差异很大。临床试验工作人员对良好临床实践知识的了解有限，也没有关于学习良好临床实践有效方法的证据。
我们使用了探索性序贯混合方法设计。我们对 18 名临床研究协调员进行了 18 次探索性定性访谈，以帮助为定量调查的发展提供信息。然后，我们在美国三个学术医疗中心对 625 名临床研究协调员进行了一项经过验证的 32 项多项选择测试，以测试他们对良好临床实践知识的掌握情况，并对他们的工作和培训经验进行了调查。与良好临床实践知识显著相关的变量被纳入多元回归分析，以确定良好临床实践知识的独特预测因素。我们控制了言语-数字推理和学习倾向。
在定性访谈中，临床研究协调员报告说，正式的良好临床实践培训有价值，但他们同时强调经验、日常实践以及观察同事和导师的重要性，认为这些是补充正式培训的必要条件。在我们的定量调查中，有五个变量总共预测了良好临床实践知识得分的 22%的方差：作为临床研究协调员的工作年限、参与不同类型的试验、支持行业资助的试验、获得临床研究协调员认证以及在线和面对面培训的累计时间（按此顺序）。
作为临床研究协调员的工作经验的持续时间和丰富程度是良好临床实践知识的最强预测因素，这一发现与我们的探索性定性访谈结果一致。我们的研究结果表明，正式的在线和面对面培训对良好临床实践知识的影响很小。培训类型（在线或面对面）对良好临床实践知识分数没有显著影响。良好临床实践知识的大部分差异仍未得到解释，这需要在该领域进行进一步研究。
