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

Abstract

This 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. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. 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. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. 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. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. 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. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.

Keywords:

• commercial feasibility
• ethics
• human subjects research
• plant-made vaccines
• translational research

Acknowledgments

The authors wish to thank Dr. Amanda Walmsley (ASU) for critical discussion during preparation of this manuscript, and Dr. David Resnik (NIEHS) for some helpful early feedback. We also thank two anonymous reviewers for thoughtful comments. Plant-made vaccine research by Dwayne D. Kirk is funded in part by Dow AgroSciences, LLC.

Dwayne D. Kirk's plant-made vaccine research is funded in part by Dow AgroSciences, LLC.

Notes

¹See http://www.gene.ch/genet/2005/May/msg00042.html and http://www.forbes.com/technology/free_forbes/2003/0120/110.html (last accessed August 8, 2005).