Kirk Dwayne D, Robert Jason Scott
School of Life Sciences, Arizona State University, P.O. Box 874501, Tempe, AZ 85287-4501, USA.
Account Res. 2005 Oct-Dec;12(4):281-97. doi: 10.1080/08989620500440279.
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 compromising 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.
本文提出，应将商业可行性评估作为人体临床试验的一项先决条件加以整合，以提高所研究材料的质量和相关性，作为保护人类受试者的一个伦理方面，并作为在临床开发基于成功转化研究的承诺获得资助时提高问责制的一种手段。目前，进行人体临床试验无需进行商业可行性分析，但假定行业参与者已经进行了此类分析，并且使用公共资金进行临床试验也应以同样的方式进行辩护。本文将植物源疫苗（PMV）作为在人体临床试验前评估商业可行性相关性的一个模型进行讨论。基于为全球许多传染病进行免疫接种的愿景，PMV已被提议作为全球健康问题的一个潜在解决方案。这样的愿景依赖于将植物科学和免疫学的现有知识转化为一种有效的疫苗，这种疫苗能够易于生产并分发给有需要的人群。但是，诸如PMV之类的新型生物制品可能会由于财务或后勤方面的原因而无法生产出来——特别是对于那些没有足够收入激励行业投资的罕见病——无论其在人体临床试验中可能证明的有效性如何。此外，所有全球健康的潜在手段都依赖于实验室之外的转化机构，以便能够惠及有需要的人群。建议监管机构和伦理审查委员会将一个包含商业可行性五个标准的模型纳入人体临床试验批准前审查过程的一部分。使用该模型可能有助于促进安全、恰当的转化研究，并为有需要的人群带来更直接的益处。
