Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee

被引:8
作者
Fuentes Camps, Inmaculada [1 ,2 ]
Rodriguez, Alexis [1 ,2 ]
Agusti, Antonia [1 ,3 ]
机构
[1] Hosp Univ Vall dHebron, Clin Pharmacol Serv, Barcelona, Spain
[2] Vall dHebron Res Inst VHIR, Barcelona, Spain
[3] Univ Autonoma Barcelona, Dept Pharmacol Therapeut & Toxicol, Barcelona, Spain
关键词
bioethics; clinical trials; clinical trials regulation; drug regulation; ethics committee; NEED;
D O I
10.1111/bcp.13555
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value.
引用
收藏
页码:1384 / 1388
页数:5
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