Clinical safety assessment of infant nutrition.

Data on clinical safety and efficacy are ideally collected in a randomized clinical trial or, failing this, an observational study. Suitable outcomes vary depending on the intervention and population group, and certain outcomes such as growth may test both efficacy and safety. The use of growth as an important safety outcome has some limitations since it is currently not clear what represents an 'optimal' growth pattern. Several issues currently make the conduct and interpretation of infant nutrition trials challenging. These include difficulties in recruiting exclusively formula-fed infants, particularly given the emotive nature of infant feeding; the involvement of industry leading to real or perceived conflicts of interest; increased regulation and bureaucracy; and particular issues with long-term follow-up studies, notably cohort attrition. This paper addresses the implications of these issues and some potential solutions.