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

British journal of clinical pharmacology, 2018-06, Vol.84 (6), p.1384-1388 [Peer Reviewed Journal]

2018 The British Pharmacological Society ;2018 The British Pharmacological Society. ;ISSN: 0306-5251 ;EISSN: 1365-2125 ;DOI: 10.1111/bcp.13555 ;PMID: 29446851

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Title:
Non‐commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee
Author: Fuentes Camps, Inmaculada ; Rodríguez, Alexis ; Agustí, Antonia
Subjects: bioethics ; clinical trials ; clinical trials regulation ; Clinical Trials, Phase II as Topic - economics ; Clinical Trials, Phase II as Topic - methods ; Clinical Trials, Phase III as Topic - economics ; Clinical Trials, Phase III as Topic - methods ; Clinical Trials, Phase IV as Topic - economics ; Clinical Trials, Phase IV as Topic - methods ; Controlled Clinical Trials as Topic - economics ; Controlled Clinical Trials as Topic - ethics ; Controlled Clinical Trials as Topic - methods ; Drug Industry - economics ; Drug Industry - ethics ; drug regulation ; ethics committee ; Ethics Committees, Research ; Humans ; Multicenter Studies as Topic - economics ; Multicenter Studies as Topic - methods ; Registries ; Research Design ; Research Support as Topic - economics ; Research Support as Topic - ethics ; Retrospective Studies ; Short Report ; Short Reports
Is Part Of: British journal of clinical pharmacology, 2018-06, Vol.84 (6), p.1384-1388
Description: 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.
Publisher: England: John Wiley and Sons Inc
Language: English
Identifier: ISSN: 0306-5251
EISSN: 1365-2125
DOI: 10.1111/bcp.13555
PMID: 29446851
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central

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

2018 The British Pharmacological Society ;2018 The British Pharmacological Society. ;ISSN: 0306-5251 ;EISSN: 1365-2125 ;DOI: 10.1111/bcp.13555 ;PMID: 29446851

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