Quality of institutional participation in multicenter clinical trials.
Quality of institutional participation in multicenter clinical trials.
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机构参与多中心临床试验的质量。
DOI：
10.1056/nejm198110083051503
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发表时间：
1981
期刊：
影响因子：
--
通讯作者：
Bonadonna,G
中科院分区：
文献类型：
--
作者：
Sylvester,RJ;Pinedo,HM;DePauw,M;Staquet,MJ;Buyse,ME;Renard,J;Bonadonna,G
我们研究了机构参与多中心临床试验的程度和参与质量之间的关系。参与的质量是根据参加试验的患者的百分比来判断的，这些患者实际上符合条件，按照方案接受了治疗，并收到了适当的表格。那些符合这些标准的人被称为“有效”患者。根据参与试验的患者数量，研究机构被分为两组，“主要参与者”和“次要参与者”。在对软组织肉瘤化疗多中心试验的详细分析中，我们发现，主要参与者的有效患者比例明显高于次要参与者(81%对39%)，从科学和管理角度来看，次要参与者实际上都对研究不利。这些结果表明，机构不应该参与多中心研究，除非它们可以输入每年预定的最低患者数量。(英国医学杂志)1981年；305：852-5。)
We studied the relation between an institution's degree of participation in a multicenter clinical trial and the quality of its participation. The quality of participation was judged on the basis of the percentage of patients entered into the trial who were in fact eligible, who were treated in accordance with the protocol, and for whom the appropriate forms were received. Those who satisfied these criteria were termed "valid" patients. Institutions were divided into two groups, "major participants" and "minor participants," according to the number of patients they entered in the trial. In a detailed analysis of a multicenter trial of chemotherapy for soft-tissue sarcoma, we found that major participants had a significantly higher percentage of valid patients than did minor participants (81 per cent vs. 39 per cent) and that the minor participants were actually detrimental to the study from both scientific and administrative viewpoints. These results suggest that institutions should not participate in multicenter studies unless they can enter some predetermined minimal number of patients per year. (N Engl J Med. 1981; 305:852–5.)
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癌症的争议：试验和治疗的设计
DOI：
--
发表时间：
1979
期刊：
影响因子：
--
作者：
H. Tagnon;M. Staquet
通讯作者：
M. Staquet
E.O.R.T.C.
影响因子：
8.4
作者：
H. Pinedo;C. Vendrik;M. Staquet;Y. Kenis;R. Sylvester
通讯作者：
R. Sylvester
核心脏病学（两部分中的第二部分）。
DOI：
10.1056/nejm198110083051504
发表时间：
1981
期刊：
The New England journal of medicine
影响因子：
--
作者：
Berger Hj;Zaret Bl
通讯作者：
Zaret Bl
合作临床试验的实践。
影响因子：
8.4
作者：
M. Staquet
通讯作者：
M. Staquet