Departments of Medicine, Health Research Evidence & Impact, McMaster University, Hamilton, Canada.
Department of Health Research Evidence & Impact, McMaster University, Hamilton, Canada.
JAMA Netw Open. 2024 Jul 1;7(7):e2420458. doi: 10.1001/jamanetworkopen.2024.20458.
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.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
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.
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.
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.
COVID-19 大流行给全球临床试验带来了前所未有的挑战，威胁着试验的过早关闭和完整性。研究运营的每个阶段都受到了影响，通常需要修改方案设计和实施。
确定与继续进行关键性护理试验相关的障碍、解决方案和机会，这些试验在大流行期间被中断，并为未来的试验提出建议。
设计、环境和参与者：这项混合方法研究进行了一项解释性序贯分析，涉及加拿大危重病试验组的主要研究者 (PI) 和项目协调员 (PC) 进行的成人和儿科个体患者随机试验的自我管理电子调查和焦点小组。合格的试验正在 2020 年 3 月 11 日招募患者。数据在 2023 年 9 月至 2024 年 1 月之间进行分析。
对试验进行和完成的障碍、所采用的解决方案、出现的机会以及对未来试验的建议的重要性评级。使用描述性统计分析对定量数据进行分析。通过定性内容分析处理解决方案、机会和建议。整合涉及对 13 项试验的多源数据和观点进行三角测量，由一个整合了反思和成员检查的跨专业团队进行综合。
共纳入了 29 名 PI 和 PC 管理的 13 项试验（参与率为 100%）。在大流行期间继续进行的最高评级障碍（五分制）是暂停所有临床研究的决定（平均[标准差]评分，4.7 [0.8]）、专注于 COVID-19 研究（平均[标准差]评分，4.6 [0.8]）和限制医院内家属的存在（平均[标准差]评分，4.1 [0.8]）。为促进试验进展和完成提出的建议包括提供科学领导力、实施沟通和数据管理技术、促进知情同意过程、根据需要调整方案、促进现场参与、启动新的现场、简化伦理和合同审查以及设计嵌套研究。大流行需要新的资金机会来维持试验的入组。它提高了公众对危重病和随机试验证据重要性的认识。
虽然强调了研究在社会中的重要作用，并使科学界团结起来，具有共同的目标，但大流行表明需要创新，以确保正在进行的试验的严谨性和完成。为优化研究程序而吸取的经验教训将有助于确保未来充满活力的临床试验事业。
