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

Br J Clin Pharmacol. 2018 Jun;84(6):1384-1388. doi: 10.1111/bcp.13555. Epub 2018 Mar 22.

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.

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

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • 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
  • 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