Literature DB >> 29446851

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

Inmaculada Fuentes Camps1,2, Alexis Rodríguez1,2, Antonia Agustí1,3.   

Abstract

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.
© 2018 The British Pharmacological Society.

Keywords:  bioethics; clinical trials; clinical trials regulation; drug regulation; ethics committee

Mesh:

Year:  2018        PMID: 29446851      PMCID: PMC5980428          DOI: 10.1111/bcp.13555

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


  16 in total

1.  Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

Authors:  Catherine De Angelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden
Journal:  N Engl J Med       Date:  2004-09-08       Impact factor: 91.245

2.  Independent clinical research in Europe.

Authors:  Giuseppe Remuzzi; Arrigo Schieppati; Jean-Pierre Boissel; Silvio Garattini; Richard Horton
Journal:  Lancet       Date:  2004 Nov 6-12       Impact factor: 79.321

3.  European Clinical Research Infrastructures Network: promoting harmonisation and quality in European clinical research.

Authors:  Jacques Demotes-Mainard; Christian Ohmann
Journal:  Lancet       Date:  2005 Jan 8-14       Impact factor: 79.321

4.  Impact of recent legislative bills regarding clinical research on Italian ethics committee activity.

Authors:  L Porcu; D Poli; V Torri; E Rulli; M C Di Tullio; M Cinquini; E Bajetta; R Labianca; F Di Costanzo; D Nitti; I Floriani
Journal:  J Med Ethics       Date:  2008-10       Impact factor: 2.903

5.  Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study.

Authors:  Allan Hackshaw; Hannah Farrant; Sue Bulley; Michael J Seckl; Jonathan A Ledermann
Journal:  J R Soc Med       Date:  2008-06       Impact factor: 5.344

6.  How frequently do the results from completed US clinical trials enter the public domain?--A statistical analysis of the ClinicalTrials.gov database.

Authors:  Hiroki Saito; Christopher J Gill
Journal:  PLoS One       Date:  2014-07-15       Impact factor: 3.240

7.  Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

Authors:  Pilar Suñé; Josep Maria Suñé; J Bruno Montoro
Journal:  PLoS One       Date:  2013-01-30       Impact factor: 3.240

8.  Fact or fiction: the need for independent pharmaceutical policy research.

Authors:  Salomeh Keyhani; Alex Federman
Journal:  J Gen Intern Med       Date:  2009-05       Impact factor: 5.128

9.  Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

Authors:  Anette Blümle; Joerg J Meerpohl; Martin Schumacher; Erik von Elm
Journal:  PLoS One       Date:  2014-02-19       Impact factor: 3.240

10.  Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers.

Authors:  Ruijun Chen; Nihar R Desai; Joseph S Ross; Weiwei Zhang; Katherine H Chau; Brian Wayda; Karthik Murugiah; Daniel Y Lu; Amit Mittal; Harlan M Krumholz
Journal:  BMJ       Date:  2016-02-17
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  2 in total

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

Authors:  Inmaculada Fuentes Camps; Alexis Rodríguez; Antonia Agustí
Journal:  Br J Clin Pharmacol       Date:  2018-03-22       Impact factor: 4.335

2.  Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT).

Authors:  Gerta Rücker; Martin Schumacher; Anette Blümle; Katharina Wollmann; Karin Bischoff; Philipp Kapp; Szimonetta Lohner; Edris Nury; Kai Nitschke; Jasmin Zähringer
Journal:  BMC Med Res Methodol       Date:  2021-08-31       Impact factor: 4.615

  2 in total

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