Assessing Commercial Feasibility: A Practical and Ethical Prerequisite for Human Clinical Testing

TitleAssessing Commercial Feasibility: A Practical and Ethical Prerequisite for Human Clinical Testing
Publication TypeJournal Article
Year of Publication2005
AuthorsKirk, D, Robert, JS
JournalAccountability in Research: Policies & Quality Assurance
Volume12
Issue4
Pagination281-297
Type of ArticleArticle
Publication Languageeng
ISSN Number08989621
Accession Number19302188
KeywordsClinical , COMMERCIAL , COMMUNICABLE , ethics , FEASIBILITY , HEALTH , Human , Human Research Subjects , IMMUNOLOGY , MEDICINE , plant-made , research , translational , VACCINES
AbstractThis article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons—particularly for orphan diseases without sufficient revenue incentive for industry investment—regardless of the effectiveness which might be demonstrated in human clinical testing. A model comprising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing.
NotesKirk, Dwayne 1,2; Email Address: dwayne.kirk@asu.edu; Scott Robert, Jason 1,3; Affiliations: 1: School of Life Sciences, Arizona State University, Tempe, AZ; 2: The Biodesign Institute, Arizona State University, Tempe, AZ; 3: Center for Biology and Society, Arizona State University, Tempe, AZ; Issue Info: Oct-Dec2005, Vol. 12 Issue 4, p281; Thesaurus Term: FEASIBILITY studies; Thesaurus Term: RESEARCH; Subject Term: CLINICAL trials; Subject Term: HUMAN experimentation in medicine; Subject Term: VACCINES; Subject Term: HEALTH; Subject Term: COMMUNICABLE diseases; Subject Term: IMMUNOLOGY; Author-Supplied Keyword: commercial feasibility; Author-Supplied Keyword: ethics; Author-Supplied Keyword: human subjects research; Author-Supplied Keyword: plant-made vaccines; Author-Supplied Keyword: translational research; Number of Pages: 17p; Illustrations: 1 Black and White Photograph, 1 Diagram, 1 Chart; Document Type: Article
DOI10.1080/08989620500440279
Short TitleAssessing Commercial Feasibility: A Practical and Ethical Prerequisite for Human Clinical Testing
Full Text

Discipline: 

Subject: 

Publication: