Overcoming Challenges with Critical Care Trials During COVID-19
Mixed methods study gathered responses from study investigators to identify barriers, solutions, and opportunities associated with continuing critical care randomized trials during the pandemic.
There is no doubting the impact of the COVID-19 pandemic on clinical research. According to a study published in the Journal of the American College of Cardiology which utilized a sample of 321,218 non–COVID-19–related trials, 5,758 were stopped from January 1, 2020, to May 31, 2020 at an average rate of 1,147 trials/month. Conversely, 22,934 trials were stopped from January 1, 2017, to December 31, 2019, at an average rate of just 638 trials/month.1
“We found that during the initial months of the COVID-19 pandemic, the rate of clinical trials that were stopped increased significantly compared with the pre-pandemic era,” the study authors wrote of their findings. “Of concern, the number of trials stopped per month increased significantly with time during the pandemic, suggesting that the consequences of the crisis may be worse than suggested by our data.”
It is clear that stakeholders needed to address a plethora of challenges to continue clinical trials during COVID-19. While many came up short and were ultimately discontinued, new strategies for the execution of trials emerged—and are still useful in the present.
A study posted on JAMA Network Open sought to identify some of these useful strategies, as well as the barriers and opportunities that were associated with continuing critical care randomized trials during the pandemic.2
“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,” the study authors wrote.
The authors 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. The trials studied were actively enrolling patients on March 11, 2020.
The analysis was then measured by importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. A combination of descriptive statistics qualitative and content analysis was used to evaluate the data.
Of 13 total clinical trials run by 29 PIs and PCs, 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]). Among suggestions to enable trial progress and completion were implementing technology for communication and data management, fostering site engagement, and streamlining ethics and contract review.
“This mixed-methods study analyzed barriers confronted by research teams managing randomized trials during the pandemic while identifying multifaceted mitigating strategies,” the authors wrote. “These included maintaining scientific leadership in crisis and implementing technology for virtual communication and data management. Trial teams suggested facilitating broader consent methods, building flexibility into protocols to ensure feasibility, and adapting them as necessary.”
“[…] the pandemic sparked innovations to ensure the rigor and safety of ongoing trials,” the authors concluded. “While increasing public awareness about the vital role of research in society and drawing the scientific community together with a common purpose, learnings from the pandemic may prove to be useful long thereafter, heralding a stronger, more vibrant clinical trials enterprise in the future.”
References
1. Gaudino M, Arvind V, Hameed I, Di Franco A, Spadaccio C, Bhatt DL, Bagiella E. Effects of the COVID-19 Pandemic on Active Non-COVID Clinical Trials. J Am Coll Cardiol. 2020 Sep 29;76(13):1605-1606. doi: 10.1016/j.jacc.2020.07.051. Epub 2020 Jul 31. PMID: 32745501; PMCID: PMC7834205.
2. Cook D, Taneja S, Krewulak K, et al. Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic. JAMA Netw Open. 2024;7(7):e2420458. doi: 10.1001/jamanetworkopen.2024.20458.
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