A Regulatory Clinical Trial Primer: Distribution Challenges And Policy Implications Of Modern Vaccine Development

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. © Emerald Group Publishing Limited