A pharmaceutical company conducts fi ve different phase I
studies on a new drug to establish its safety in healthy individuals. Three of
these studies had a p-value < 0.05,="" indicating="" signifi="" cant="" results;="" two="" had="" a="" p-value=""> 0.05, indicating nonsignifi cant results. As it so happens,
undesirable side effects were observed in one of the studies with the
nonsignifi cant results. None of the studies with signifi cant results had a
signifi cant proportion of side effects. The researchers report these results
to the U.S. Food and Drug Administration and in a publication, but they do not
mention the nonsignifi cant results.
• Is there an ethical responsibility to report all of the
data? Would it make a difference if the subjects were not human (i.e.,
animals)?
• What are the responsibilities of the researchers to this
company, to themselves, and to society?
• Should there be a federal mandate to report all side
effects?
• How could the GRP help in this case? Would a quality
assurance program be helpful?
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