Studies intended solely to refine measures are considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials.
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Clinical research refers to the subset of human subjects research which focuses on interventions to improve human health and well-being.
A. 对
B. 错
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.
A. 对
B. 错
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.
A. 对
B. 错
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.
A. 对
B. 错