ABSTRACT

The pharmaceutical industry manufactures a consumer product: the drug. The industrial terms of reference are those in which management of the time and resources needed to introduce a new drug on to the market are essential elements. The medical terms of reference demand soundly based and clearly documented hypotheses as a basis for considering the potential administration of a new substance to man and a range of trials exposing several tens of healthy volunteers and, sometimes, hundreds of patients. A drug is an industrial consumer product which costs an enormous amount of money to introduce on the market. The organisation of a programme of Phase I and Phase II studies on a new substance must not be confused with the organisation of the clinical trials themselves, but seen as an enterprise which will lead to the disciplines mentioned to work together.