Abstract:
Consumer demand for scientifically backed products has led to a surge of demand for functional
food products and ingredients. Due to rising healthcare costs and greater desires to control their
health, consumers are increasingly turning to functional foods as a cheaper, more natural
substitute to medicines. A more educated consumer-base and the regulations surrounding
nutritional-content claims leads functional food products to require evidence through clinical
studies. However, clinical trials have largely existed within the pharmaceutical space, so
operational knowledge is mostly siloed within that industry.
The main objective of this thesis research is therefore to understand how to begin functional food
clinical trials by reviewing the regulations and standards for conducting clinical trials, determining
evaluation criteria for clinical trial processes, and discovering clinical operation processes;
including employing a qualitative methodology to analyse themes and processes from 8
interviews. This methodology uses an adapted Context Input Process Product evaluation
framework to determine the evaluation criteria.
The main findings of this research show that clinical trial and operations processes involved in
functional food testing generally follow Good Clinical Practice, but the exact pathway depends on
the desired outcome, thereby influencing the preceding processes. Collaborations play an
important role at all stages of the clinical trial process and were explored incorporating both
industry and academic perspectives. Importantly, the findings of this thesis differ from others in
the pharmaceutical, or functional food literature by including insight into the participants’ values,
which were shown to impact how researchers collaborate and share knowledge. The primary
themes were clinical operations expertise, reliance on international markets, and the importance
of regulatory compliance. The process analysis yielded four main categories of processes:
Planning, Executing, Closing Out and Accessing the Market. These are structured in a process
map that may guide beginners to the clinical trial space.
This thesis research is the first of its kind in New Zealand, and as such its contributions are seen
largely as bringing together information and expertise that was previously passed on through
professional practice. In doing so, this thesis and its findings form a general guide for industry use
in establishing a clinical trial program or to inform early clinical trial strategy.