Similarities and Difference between Clinical Trials for Foods and Drugs

Many different types of clinical trials are designed by manufacturing companies and others to explore specific product features impacting human health.In addition, many government organizations regulate clinical trials and claims about trial findings globally, including the United States (US) Food and Drug Administration (FDA) and Federal Trade Commission (FTC) as well as the European Medicines Agency (EMA), European Food Safety Authority (EFSA) and other governments and agencies.Food trials are often designed to evaluate specific marketing claims needing scientific substantiation while drug trials document the safety and efficacy of a specific drug for a specific intended use (e.g., to treat, mitigate or cure a human disease).Food trials tend to be more pragmatic and exploratory as they document human experiences with specific foods in the context of the human diet while drug trials tend to be more explanatory as they document specific drug doses and schedules and specific disease responses.Food trials typically enroll healthy individuals while drug trials enroll patients with a specific disease type potentially needing the research treatment.Foods are complex mixtures of ingredients (e.g., plant parts, meats, eggs, chemicals, beverages, whole meals, etc.) designed to be palatable and which may have the general health effect under investigation while drugs are highly purified and designed to have a specific effect on a disease.This narrative review will begin to differentiate clinical trials for foods versus those for drugs by briefly discussing the history of clinical trial designs, diversity in clinical trial regulations and the differences in specific food and drug trial requirements.