How clinical evidence is designed, graded and reported

Every claim in clinical and aesthetic practice rests on a study, and studies differ in how much weight they can bear. Randomization, blinding, control arms, pooled analyses and bias assessment are the tools researchers use to decide how far a result can be trusted.

These references explain those methods for clinicians and researchers, from the hierarchy of evidence to the phases of an FDA clinical program, with numbered citations to the methodological literature and official sources on every page.

The references, in reading order

6 references, each with numbered citations to the peer-reviewed literature.

How trials are designed and run

The design features that make a randomized trial credible, the control arms procedure-based studies use, and the phases that take a product from an IND to an FDA decision.

This page is provided for informational purposes only. It is not medical advice, it is not intended to diagnose, treat, cure, or prevent any disease, and it is not a substitute for the judgment of a licensed practitioner. Consult a healthcare professional before acting on anything stated here. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. These references describe how clinical and laboratory research is designed, graded and reported, for professional education, and make no statement about the efficacy or composition of any product. There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research, are not intended to diagnose, treat, cure, mitigate or prevent any disease, and, as secreted cell products, are not tissue products (HCT/Ps) under 21 CFR 1271.3(d)(3).