CRISMA Laboratory, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Crit Care Med. 2010 Feb;38(2):527-32. doi: 10.1097/CCM.0b013e3181c0259d.
To propose ways in which clinical trials in intensive care can be improved.
An international roundtable conference was convened focused on improvement in three broad areas: translation of new knowledge from bench to bedside; design and conduct of clinical trials; and clinical trial infrastructure and environment.
The roundtable recommendations were: improvement in clinical trials is a multistep process from better preclinical studies to better clinical trial methodology; new technologies should be used to improve models of critical illness; diseasomes and theragnostics will aid inpatient population selection and more appropriate targeting of interventions; broader study end points should include morbidity as well as mortality; more multicenter studies should be conducted by national and international networks or clinical trials groups; and better collaboration is needed with the industry.
There was broad agreement among the roundtable participants regarding a number of explicit opportunities for the improvement of clinical trials in critical care.
提出改进重症监护临床试验的方法。
召开了一次国际圆桌会议，重点讨论了三个广泛领域的改进措施：将基础研究的新知识转化为床边治疗；临床试验的设计和实施；临床试验的基础设施和环境。
圆桌会议的建议包括：临床试验的改进是一个多步骤的过程，从更好的临床前研究到更好的临床试验方法；应利用新技术改进危重病模型；疾病组和治疗学将有助于选择住院患者人群，并更恰当地针对干预措施；更广泛的研究终点应包括发病率和死亡率；更多的多中心研究应由国家和国际网络或临床试验组进行；需要与行业更好地合作。
圆桌会议参与者就重症监护临床试验的一些明确改进机会达成了广泛共识。
