PDF(Pubmed)
Abstract：
UNASSIGNED: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation.
UNASSIGNED: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials.
UNASSIGNED: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024.
UNASSIGNED: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking.
UNASSIGNED: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence.
UNASSIGNED: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.
UNASSIGNED: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials.
UNASSIGNED: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024.
UNASSIGNED: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking.
UNASSIGNED: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence.
UNASSIGNED: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.
摘要：
COVID-19大流行给全球临床试验带来了前所未有的挑战，威胁过早关闭和审判完整性。研究行动的每个阶段都受到影响，经常需要修改协议设计和实现。
■为了识别障碍，解决方案,以及与在大流行期间中断的持续重症监护试验相关的机会，并为未来的试验提供建议。
■这项混合方法研究进行了解释性序贯分析，其中包括自我管理的电子调查以及主要研究者（PI）和项目协调员（PC）的焦点小组，在COVID-19大流行期间进行加拿大重症监护试验组的成人和儿科患者随机试验。符合条件的试验于2020年3月11日积极招募患者。数据在2023年9月至2024年1月之间进行了分析。
■试验进行和完成障碍的重要性评级，采用的解决方案，出现的机会，并提出了未来试验的策略。使用描述性统计分析检查障碍的定量数据。数据寻址解决方案,机遇,并通过定性内容分析对建议进行了分析。集成涉及对13项试验的数据源和观点进行三角测量，由一个包含反身性和成员检查的跨专业团队合成。
■共纳入了由29个PI和PC进行的13项试验（参与率为100%）。大流行期间持续行为的最高等级障碍（5分制）是决定暂停所有临床研究（平均[SD]得分，4.7[0.8]),专注于COVID-19研究(平均[SD]得分，4.6[0.8]),和限制家属在医院的存在(平均[SD]得分，4.1[0.8])。使试验进展和完成的建议包括提供科学领导，通信和数据管理的实施技术，促进知情同意过程，根据需要调整协议，促进现场参与，启动新网站，简化道德操守和合同审查，设计嵌套研究。大流行需要新的资助机会来维持试验登记。它提高了公众对危重病的认识和随机试验证据的重要性。
■在强调研究在社会中的重要作用并将科学界与共同目标联系在一起的同时，大流行表明需要创新，以确保正在进行的试验的严格性和完成性。优化研究程序的经验教训将有助于确保未来充满活力的临床试验企业。
■为了识别障碍，解决方案,以及与在大流行期间中断的持续重症监护试验相关的机会，并为未来的试验提供建议。
■这项混合方法研究进行了解释性序贯分析，其中包括自我管理的电子调查以及主要研究者（PI）和项目协调员（PC）的焦点小组，在COVID-19大流行期间进行加拿大重症监护试验组的成人和儿科患者随机试验。符合条件的试验于2020年3月11日积极招募患者。数据在2023年9月至2024年1月之间进行了分析。
■试验进行和完成障碍的重要性评级，采用的解决方案，出现的机会，并提出了未来试验的策略。使用描述性统计分析检查障碍的定量数据。数据寻址解决方案,机遇,并通过定性内容分析对建议进行了分析。集成涉及对13项试验的数据源和观点进行三角测量，由一个包含反身性和成员检查的跨专业团队合成。
■共纳入了由29个PI和PC进行的13项试验（参与率为100%）。大流行期间持续行为的最高等级障碍（5分制）是决定暂停所有临床研究（平均[SD]得分，4.7[0.8]),专注于COVID-19研究(平均[SD]得分，4.6[0.8]),和限制家属在医院的存在(平均[SD]得分，4.1[0.8])。使试验进展和完成的建议包括提供科学领导，通信和数据管理的实施技术，促进知情同意过程，根据需要调整协议，促进现场参与，启动新网站，简化道德操守和合同审查，设计嵌套研究。大流行需要新的资助机会来维持试验登记。它提高了公众对危重病的认识和随机试验证据的重要性。
■在强调研究在社会中的重要作用并将科学界与共同目标联系在一起的同时，大流行表明需要创新，以确保正在进行的试验的严格性和完成性。优化研究程序的经验教训将有助于确保未来充满活力的临床试验企业。
