The role of research--how much is enough?
A great deal of research is involved in bringing PARNUTs to the marketplace. Research often begins with identifying an unfilled nutritional need, determining if that need is great enough to warrant development of a new product, and then evaluating the efficacy and safety of the potential product in animal models and clinical trials. This approach tends to emphasize short-term outcomes, however, while neglecting the issues of whether a product offers long term benefit or holds long term risks. This article presents discussion centered around the need for selecting appropriate outcomes for nutritional intervention trials, designing trials with a follow-up time sufficient to allow for outcome measurement, and enrolling a patient population large enough to accurately gauge efficacy and tolerability.
Rigo
J
J
Hôpital de la Citadelle, Liege, Belgium.
Morley
R
R
Koletzko
B
B
D000818:Animals; D005524:Food Technology / Q000639:trends*; D006801:Humans; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D012106:Research / Q000191:economics; D012107:Research Design