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An international regulatory clinical trial comparative

Beth Ann Fiedler (University of Central Florida, Jacksonville, Florida, USA)
Robert J. Bebber (United States Navy, Japan)

International Journal of Pharmaceutical and Healthcare Marketing

ISSN: 1750-6123

Article publication date: 21 June 2013

343

Abstract

Purpose

The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development.

Design/methodology/approach

Exploratory review of clinical trial processes of three industrialized nations with similar democratic processes – Japan, the UK and the USA – in order to determine the efficacy of international clinical trials.

Findings

Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.

Originality/value

This study's contribution to academic literature is threefold: first, it reviews established fundamental clinical trial processes for Japan, the UK and the USA; second, it distinguishes similarities and differences to determine best practices; and third, it suggests changes in regulatory vaccine clinical trials towards achieving global health objectives.

Keywords

Citation

Fiedler, B.A. and Bebber, R.J. (2013), "An international regulatory clinical trial comparative", International Journal of Pharmaceutical and Healthcare Marketing, Vol. 7 No. 2, pp. 199-215. https://doi.org/10.1108/IJPHM-04-2013-0014

Publisher

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Emerald Group Publishing Limited

Copyright © 2013, Emerald Group Publishing Limited

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