Principles for the conduct of non-drug clinical studies*.
Synopsis The World Medical Association's Declaration of Helsinki outlines the principles for the conduct of drug and non-drug clinical studies. The key difference between drug and non-drug biomedical research is to be seen in the fact that for non-drugs, the potential benefits, hazards and discomforts for the volunteer enrolled in a clinical study cannot be weighed against advantages of improving current diagnostic or therapeutic methods. The principles reflected in the Guidelines for Good Clinical Practice for Trials on Medicinal Products in the European Community, issued by the Commission of the European Communities in substantial parts also apply for trials on non-medicinal products. Specifically this is true with regard to the requirements for the privacy, integrity, and well-being of volunteers subjected to research, and fully informing them about the risks and benefits potentially associated with the use of a test product. Skin care products are the most prominent group of non-drug products for which clinical studies are conducted. Using these products, the key differences between executing the principles in a non-drug and a drug clinical study are highlighted.
Schmitt
G J
GJ
Medical Director Beauty Care Europe. Procter & Gamble GmbH, Sulzbacher Str. 40, 65818 Schwalbach/Ts., Germany.