ANNEGRET NIELSEN
Senior Consultant, analyze&realize GmbH, Berlin, Germany

Abstract

The global market for infant nutrition is growing very fast. With it, the demand for high-quality infant studies is also increasing. This article highlights potential pitfalls and presents the most promising approaches for planning and conducting such clinical trials. This includes topics such as the recruitment of investigators and infants as well as tackling logistical challenges, but also the sensitive view of ethics committees on infant formula studies. In addition, a brief overview of the legal framework for conducting such studies and the product category in general is given.

INTRODUCTION
Infant formula is fed to babies up to the first 12 months of life and is intended to meet nutritional needs until suitable complementary foods are introduced. In principle, infant formula is intended to be as similar as possible to breast milk and to be an adequate substitute if the mother is unable to breastfeed. According to data from WHO, in industrialised countries, only 25% of infants are exclusively breastfed at the age of 6 months, with differing proportions of breastfeeding across Europe (1). Data on the global retail market of baby milk and food forecast stronger growth for the Asian market in terms of market volume and per capita consumption. In Europe, North and South America, the market tends to stagnate at a higher level (2). As infants are a particularly vulnerable group, the requirements for placing these products on the market are highly regulated in most markets.
Above all, the safety and tolerability of new, innovative ingredients must be proven in clinical trials, while special aspects must also be considered for these trials.

BRIEF OVERVIEW ON THE REGULATORY LANDSCAPE
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