New-drug assessment in man: a clinical pharmacologist’s view

One of the central roles of the clinical pharmacologist is the assessment of new drugs in man and in this respect he has a necessarily close relationship with the pharmaceutical industry. He is largely dependent on industry for the production of new chemical entities (NCE) but his independence of judgement must be preserved at all costs. Industry in its turn appreciates that competent independent arbiters of their new products are important for its prosperity. Currently both parties, clinical pharmacology and industry feel threatened by a third party, governmental drug regulatory authorities. The purpose of this article is to delineate problems currently faced by the clinical pharmacologist in new drug assessment and to suggest some possible solutions.