Clinical Trials and Neutraceuticals

Clinical trials in humans can be expensive. For neutraceutical clinical trials to be successful and cost-effective, trial objectives must be focused. Animal study data, documentation and results can provide this unique added focus to better enhance the development of a clinical study protocol that is "likely" to generate a positive outcome.

There are several possible approaches for neutraceutical product development. A balanced approach of doing some preclinical testing before, during and after the clinical phase of R&D is prudent and recommended. Remember that each product is different and thus there is no set rule in development. Several "approaches", that safely and conscientiously consider both animal testing and human clinical trials is strongly recommended. The clinical trials can be, for examples, a small pilot clinical study in humans or a proof of concept clinical study in humans. Either would provide useful, hopefully positive outcome information that will be used in future clinical development considerations.

Whether animal or human, testing or clinical study, respectively, remember to apply GLP and GCP as per FDA regulatory rigor and guidance - and quality control all data and documentation early, often and always.