Textbook of Pharmaceutical Medicine warns of trial risks

摘要

"For example, the study design may require administration of intravenous infusions to six volunteers. It may be perfectly feasible to perform these on a single day but it is inadvisable to start all the infusions simultaneously. Drug-related adverse reactions would be likely to occur at the same time in all the subjects, which could be very difficult to manage and put subjects at unnecessary risk. Indeed, it may be wise to stop the study after the first significant adverse reaction has been detected and reconsider the dose, speed of administration or whether to proceed at all."