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Formalized phase 0 studies are a relatively recent phenomenon involving the testing of interventions and methods which might be used in later phase studies. A phase 0 study might be designed to determine the mechanism of action of a particular drug and evaluate different ways to administer it.
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If phase 1 testing is successful, potential new treatments go on to larger phase 2 studies which are designed to further assess risks and also to evaluate whether there is any evidence that the treatment might be beneficial.
Clinical research which poses net risks raises important ethical concern. Net-risk studies raise concern that subjects are being used as mere means to collect information to benefit future patients. Research procedures that pose net risks may seem to raise more concern when they are embedded within a study which offers a favorable risk-benefit profile overall.
James Lind's (1716-1794) experiments on the treatment of scurvy inBritish sailors represent perhaps the first modern clinical trial because he attempted to address one of the primary challenges facing those who set out to evaluate medical treatments.
Hippocratic medicine tended to be very aggressive and observational rather than experimental. Common remedies prescribed by Hippocratic physicians included special diets, herbal medicines, exercise, baths, and massage.
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