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Article
Publication date: 21 June 2013

Beth Ann Fiedler and Robert J. Bebber

The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory…

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.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 2
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 29 March 2013

Beth Ann Fiedler, Robert J. Bebber and Reid M. Oetjen

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of…

Abstract

Purpose

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies.

Design/methodology/approach

A systematic review of literature for the period of 2000‐2010 was conducted by searching academic databases of peer‐reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand‐searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing.

Findings

Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution.

Practical implications

Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross‐cultural global delivery system.

Originality/value

This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Keywords

Content available
1292

Abstract

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Content available
153

Abstract

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 2
Type: Research Article
ISSN: 1750-6123

Book part
Publication date: 13 October 2008

Amalia M. Issa

An important current trend in health care is the move toward personalized medicine. Personalized medicine includes diagnostic and therapeutic interventions, with risk defined…

Abstract

An important current trend in health care is the move toward personalized medicine. Personalized medicine includes diagnostic and therapeutic interventions, with risk defined through genetics. The key paradigm shift brought about by the advent of personalized medicine is the increased use of in vitro genomic diagnostics. These tests offer the potential of being able to predict which patients are likely to respond to a particular drug, or which patients are likely to develop adverse reactions to a drug. The focus of this paper is the use of genomic diagnostics, and how the increasing development and translation into clinical practice of diagnostic – drug combination products will be adopted into health care delivery. The meaning of value and how to measure it is considered from different perspectives. A novel framework for evaluating the value of genomic diagnostics is proposed. Finally, the implications for regulatory approval and policy are discussed using an illustrative case study.

Details

Beyond Health Insurance: Public Policy to Improve Health
Type: Book
ISBN: 978-1-84855-181-7

Article
Publication date: 24 July 2023

Robert Gandy, Peter Wolstencroft, Katherine Geer and Leanne de Main

The recruitment of undergraduate students within English universities is of vital importance to both the academic success and the financial stability of the organisation. Despite…

Abstract

Purpose

The recruitment of undergraduate students within English universities is of vital importance to both the academic success and the financial stability of the organisation. Despite the primacy of the task, there has been a dearth of research looking at related performance and how to ensure that the process is optimised. The purpose of this study was to investigate the degree of variation both within a university and between different universities. The reliance that individual programmes and/or universities place on the Clearing process is key; given its uncertainty, resource demands and timing shortly before students take up their places.

Design/methodology/approach

The Nomogramma di Gandy diagrammatical approach utilises readily available data to analyse universities’ performance in recruiting students to different programmes, and the degree to which they each rely of the Clearing process. Inter-university performance was investigated on a whole-student intake basis for a sample of English universities, representative of type and region.

Findings

The study found that there were disparate patterns for the many programmes within the pilot university and also disparate patterns between different types of universities across England. Accordingly, universities should internally benchmark their programmes to inform both strategic and tactical decision-making. Similarly, Universities and Colleges Admissions Service benchmarking inter-university patterns could inform the overall sector.

Originality/value

The approach and findings provide lessons for analysing student recruitment which could be critical to universities’ academic and financial health, in an increasingly competitive environment.

Details

Benchmarking: An International Journal, vol. ahead-of-print no. ahead-of-print
Type: Research Article
ISSN: 1463-5771

Keywords

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