期刊
INTENSIVE CARE MEDICINE
卷 46, 期 5, 页码 930-942出版社
SPRINGER
DOI: 10.1007/s00134-020-05934-6
关键词
Critical care; Clinical trials; Acute respiratory distress syndrome; Sepsis
资金
- United States National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) [K99 HL141678, R00 HL141678]
- NIH/NHLBI [T32HL08773812, K12HL133117]
- NHLBI [U01HL123009, U01 HL 123004, HL140026, HL134828, UH2 HL125119, U01 HL122998, U01 HL123009]
- AHRQ [R18 HS026188]
- NCRR [U54 RR 032646]
- NCATS [U24 TR 001608]
- NIGMS [K23GM110469]
- Canadian Institutes of Health Research [MYG158584]
Background Conducting research in critically-ill patient populations is challenging, and most randomized trials of critically-ill patients have not achieved pre-specified statistical thresholds to conclude that the intervention being investigated was beneficial. Methods In 2019, a diverse group of patient representatives, regulators from the USA and European Union, federal grant managers, industry representatives, clinical trialists, epidemiologists, and clinicians convened the First Critical Care Clinical Trialists (3CT) Workshop to discuss challenges and opportunities in conducting and assessing critical care trials. Herein, we present the advantages and disadvantages of available methodologies for clinical trial design, conduct, and analysis, and a series of recommendations to potentially improve future trials in critical care. Conclusion The 3CT Workshop participants identified opportunities to improve critical care trials using strategies to optimize sample size calculations, account for patient and disease heterogeneity, increase the efficiency of trial conduct, maximize the use of trial data, and to refine and standardize the collection of patient-centered and patient-informed outcome measures beyond mortality.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据