{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T06:02:08Z","timestamp":1787724128456,"version":"build-2784847793"},"reference-count":53,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi240656-4\"><jats:title>Importance<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi240656-5\"><jats:title>Objectives<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi240656-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi240656-7\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi240656-8\"><jats:title>Results<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi240656-9\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.20458","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T15:31:39Z","timestamp":1720798299000},"page":"e2420458","source":"Crossref","is-referenced-by-count":15,"title":["Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic"],"prefix":"10.1001","volume":"7","author":[{"given":"Deborah","family":"Cook","sequence":"first","affiliation":[{"name":"Departments of Medicine, Health Research Evidence & Impact, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shipra","family":"Taneja","sequence":"additional","affiliation":[{"name":"Department of Health Research Evidence & Impact, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karla","family":"Krewulak","sequence":"additional","affiliation":[{"name":"Department of Critical Care, University of Calgary, Calgary, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Zytaruk","sequence":"additional","affiliation":[{"name":"Department of Health Research Evidence & Impact, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kusum","family":"Menon","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Ottawa, Ottawa, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"Fowler","sequence":"additional","affiliation":[{"name":"Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Lamontagne","sequence":"additional","affiliation":[{"name":"Department of Critical Care, Universit\u00e9 de Sherbrooke, Sherbrooke, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle E.","family":"Kho","sequence":"additional","affiliation":[{"name":"School of Rehabilitation Science, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bram","family":"Rochwerg","sequence":"additional","affiliation":[{"name":"Departments of Medicine, Health Research Evidence & Impact, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-H\u00e9l\u00e8ne","family":"Masse","sequence":"additional","affiliation":[{"name":"Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Lauzier","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Universit\u00e9 Laval, Qu\u00e9bec City, Canada"},{"name":"CHU de Qu\u00e9bec-Universit\u00e9 Laval Research Center, Qu\u00e9bec City, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"O\u2019Hearn","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Eastern Ontario Research Institute, Ottawa, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neill K. 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