Clinical Trials in Infant Nutrition

A comprehensive examination of the methodological, statistical and ethical problems of conducting clinical trials in paediatric nutrition. Randomized trials, meta-analyses and multi-centre studies - and the advantages and disadvantages of each - are discussed at length. Topics covered include the legislative framework of industrialized countries where trials are conducted; moral obligations in developing countries, particularly where ethics committees have not been established; regulations for formulating product claims that do not discourage breast feeding; and adherence to the ethics of protecting infants and children. The monograph seeks to give established and future investigators a better understanding of the most appropriate methods for clinical trials, and provides insight and inspiration to biostatisticians, ethics committee members, and the paediatric community.