Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing

Area of Science:

• Biotechnology
• Translational Research
• Vaccinology

Background:

• Current clinical trial approval processes do not mandate commercial feasibility assessments.
• Industry participants often assume commercial feasibility, but public funding requires similar justification.
• Plant-made vaccines (PMVs) represent a potential global health solution but face manufacturing and distribution challenges.

Purpose of the Study:

• To propose integrating commercial feasibility assessments as a prerequisite for human clinical testing.
• To enhance the quality, relevance, and ethical considerations of investigational materials.
• To improve accountability in translational research, especially for publicly funded clinical trials.

Main Methods:

• The article discusses the relevance of commercial feasibility using plant-made vaccines (PMVs) as a model.
• A five-criterion model for commercial feasibility is suggested for regulatory and ethics review.
• The model aims to guide regulators and ethics review boards in approving human clinical testing.

Main Results:

• Commercial feasibility analysis is crucial for the successful translation of novel biologics, including PMVs.
• Failure to consider commercial viability can halt promising medical innovations, particularly for rare diseases.
• Integrating feasibility assessments can facilitate appropriate translational research and deliver timely benefits.

Conclusions:

• Mandatory commercial feasibility assessments are essential before initiating human clinical trials.
• This integration ensures ethical subject protection, research relevance, and financial accountability.
• A proposed five-criterion model can guide regulatory bodies in evaluating translational research proposals.