[Randomize the first patient?].

Abstract

Therapeutic innovation requires rigorous assessment, to fulfil regulatory and ethical constraints. The ideal time for this assessment in the therapeutic progress story is a complex question, mixing individual and collective ethical principles. Randomisation of the first patient is always, at least theoretically, a current issue, extending beyond drug research to reach the wider field of technical innovation. Broad information of consumers, their involvement in clinical research policy, and specific training for prescribers, could be the conditions to make clinical research ethically acceptable.