Title

An International Regulatory Clinical Trial Comparative

Keywords

Clinical trials; Immunization; Immunological prophylaxis; Japan; National cultures; National policy; Preventative medicine; Product testing; Regulation; United Kingdom; United States of America; Vaccine approval

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. © Emerald Group Publishing Limited.

Publication Date

6-1-2013

Publication Title

International Journal of Pharmaceutical and Healthcare Marketing

Volume

7

Issue

2

Number of Pages

199-215

Document Type

Article

Personal Identifier

scopus

DOI Link

https://doi.org/10.1108/IJPHM-04-2013-0014

Socpus ID

84879359346 (Scopus)

Source API URL

https://api.elsevier.com/content/abstract/scopus_id/84879359346

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