Early clinical evaluation in man: the buck stops here.

The development of new drugs as potential therapeutic agents involves multi-discipline 'team' research. The clinician has to deal with scientific and ethical issues and keep in mind the axiom 'Primum no nocere--Above all, do no harm.' The clinical pharmacologist has to address the pharmacologic actions of a potential new drug and if any antidotes are available. Species in pharmacologic actions, assessment of animal laboratory data to determine the sensitive organs, and the role of drug metabolism in evaluating and correlating animal data all need to be addressed. The clinical pharmacologist has an important role in new drug development which is unique and includes the responsibility to ensure the welfare of the volunteer subjects or patients.