Good Clinical Practice is the same for food and drug trials with many of the detailed procedures and processes overlapping. Understanding the differences and nuances involved, contributes to successful design, delivery and ultimately positive outcomes.
The need to invest
Boundaries between some drugs and functional foods are blurring as the two sectors look to meet the needs of the same consumers, but with different purchasing approaches. Foods have a lower effect size generally, but a broader buying audience while drugs have a higher effect with a narrow consumer focus. This however is not evident in the way we now approach the R&D process with food companies upping their game considerably over the past 10 years.
The industry drive to provide functional health claims, which ultimately leads to increased sales, is certainly a major contributor to the uplift in food clinical trials. However, demand is further driven by regulatory bodies’ requirement for scientific substantiation which invariably takes the form of human clinical trial. Randomised Human Clinical Trials (RCTs) are considered the gold standard of evidence for the scientific substantiation of claims by the European Food Safety Authority, the Food and Drug Adminstration and other regulators around the globe. RCTs add the depth of knowledge required by consumers to make informed purchasing decisions which will not negatively impact their wellbeing, while providing effective product ranges for disease prevention.
The proliferation of clinical data is making it hard for companies to compete if they lack evidence of the effects of their products in humans. Clinical trial data can enable companies to capture market share and command premium prices, but companies must invest time and money to generate the evidence that unlocks these opportunities. Clinical trials require time, planning and of course, budget. Timelines and budget will vary depending on many attributes such as the type of partner the organisation is working with, the sample size required to show effect, the difficulty level in population selection and the scientific knowledge and technology to measure the desired outcomes.
Educated consumers driving demand for validation
Today’s consumers are more proactive thanks to accessibility to information and when researching about their health spend a considerable amount of time looking at product portfolios and companies who invest in the clinical data needed to show them the benefits of their product. In fact, 80% percent of American Internet users have searched for a health-related topic online, however, just 12% believe nutrition researchers are transparent about potential conflicts of interest with industry, according to a study released by the Pew Internet & American Life Project. Americans have more positive and trusting views of dietitians (54%) than nutrition researchers (28%). These stats show that consumers need to be educated, but also dietitians and other healthcare professionals since they are the main reference for consumers, considering the American example.
This education of the consumer can be supported by health professionals in their environment, through traditional or online channels. Even if consumers are unable to fully grasp the technical aspects of the health claims, influencers such as health care professional can simplify this data and have a great impact on the buying decision.