There are many situations where clinical trials for NHPs
may need to be conducted. One of the key reasons to conduct a clinical trial is to demonstrate an ingredient/product is safe and efficacious at various dosage levels, especially when:
- No previous studies have been conducted or published
- New conditions not captured on the product label are seeking evidence for support
Clinical studies can vary in complexity. They can include a meta-analysis of studies that leads to a multi-center, double-blind, placebo-controlled human clinical trial. For such a study to be acceptable for a natural health product, the protocol for clinical trials as outlined by the NNHPD must be followed. The clinical trial format should also follow the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines.