Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.
Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.
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DOI：
10.6004/jnccn.2020.7643
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发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Lee SJC
中科院分区：
文献类型：
--
作者：
Gerber DE;Sheffield TY;Beg MS;Williams EL;Clark VL;Xie Y;Holbein MEB;Skinner CS;Lee SJC
在2019冠状病毒病突发公共卫生事件期间，美国食品药品监督管理局（FDA）和美国国立卫生研究院（NIH）发布了关于开展临床试验的指导意见，包括保护参与者和管理研究开展的调整。鉴于他们对研究方案的详细了解以及与患者、临床医生和申办者的定期接触，临床研究专业人员对这些变化提供了重要的观点。我们开发并分发了一份匿名调查，评估COVID-19相关临床试验调整的经验、看法和建议，以供哈罗德C.西蒙斯综合癌症中心使用Fisher精确检验比较反应。在109名联系的研究人员中，共有94人（87%）做出了回应。在这些人中，58%的人拥有超过5年的临床研究专业经验，56%的人有COVID-19相关变化的个人经历。受访者认为这些变化对患者安全性、治疗疗效、患者和工作人员体验以及与患者、研究者和申办者的沟通产生了积极影响。超过90%的受访者认为，在COVID-19之后，积极的变化应该继续下去。对于远程同意、远程医疗、治疗运送、非现场诊断和远程监测，具有特定变化的个人经验的个人和具有>5年专业经验的个人在数字上更有可能建议继续调整，并且这些差异对于远程医疗（P=0.04）和治疗运送（P=0.02）是显著的。临床研究专业人士认为，COVID-19相关的临床试验调整对研究开展的多个方面产生了积极影响。那些对COVID-19变化和更普遍的变化有最丰富经验的人更有可能建议未来继续进行这些调整。
During the COVID-19 public health emergency, the Food and Drug Administration and the National Institutes of Health have issued guidance on the conduct of clinical trials, including adjustments to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. We developed and distributed an anonymous survey assessing COVID-19-related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel in the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using Fisher’s exact test. A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had more than 5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19-related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. Over 90 percent felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=0.04) and therapy shipment (P=0.02). Clinical research professionals perceive that COVID-19-related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19 changes and more generally—are more likely to recommend these adjustments continue in the future.
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作者：
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DOI：
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发表时间：
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