When a marketing claim pertains to effects on human health, the process of claims substantiation starts with preclinical testing, and proceeds through clinical studies, with an end goal of publication. Nevertheless, planning a clinical study in the natural products industry is far from simple, since most natural products have multi-faceted and complex effects on human health.
Dependent on the marketing claims that you seek to substantiate, the study design will be tailored to those needs. Our experience, as a clinical research organization, includes acute studies on rapid effect in vivo and ex vivo of natural products, as well as long-term immune studies, studies of inflammation management including chronic pain and weight management, joint function studies, and studies on vascular health. We have conducted numerous other types of studies, including evaluation of stem cell mobilization, mitochondrial function, antioxidant status, and cardiovascular health.
Following a process through preclinical testing, proof-of-concept, pilot, and full clinical studies helps maximize the probability of a successful research plan. The following strategic sequence is beneficial when designing clinical studies on natural products.
A typical proof-of-concept study involves few subjects but a broad panel of questions, measurements, and biomarkers. This is an important phase to identify which biomarkers your product seems to affect. A proof-of-concept study may also involve multiple timepoints in order to determine the timing of a measurable effect in humans. The data from this type of study sets the tone for future clinical studies.
A typical pilot study focuses on selected questions, measurements, and biomarkers, based on data from a proof-of-concept study. However, a pilot study will still incorporate multiple measures of which each may carry value for support of your specific marketing claim. A pilot study may also be combined with a dose study, such that an ideal dose can be decided prior to product launch, as well help guide which dose(s) are used for full clinical studies.
The gold standard for clinical documentation is the randomized, double-blind placebo-controlled clinical trial. Planning for a trial to be successful requires well-defined goals, study population, and decisions on which types of data to collect. Clinical studies are specifically designed with the goal of manuscript writing for peer-reviewed publication.