Safety
Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study, and (in some cases, if the study involves a marketable drug or device), the regulatory agency for the country where the drug or device will be sold.
For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures.
Read more about this topic: Clinical Trial
Famous quotes containing the word safety:
“There is no calamity which a great nation can invite which equals that which follows a supine submission to wrong and injustice and the consequent loss of national self-respect and honor, beneath which are shielded and defended a people’s safety and greatness.”
—Grover Cleveland (1837–1908)
“There was only one catch and that was Catch-22, which specified that a concern for one’s own safety in the face of dangers that were real and immediate was the process of a rational mind.... Orr would be crazy to fly more missions and sane if he didn’t, but if he was sane he had to fly them. If he flew them he was crazy and didn’t have to; but if he didn’t want to he was sane and had to.”
—Joseph Heller (b. 1923)
“For hours, in fall days, I watched the ducks cunningly tack and veer and hold the middle of the pond, far from the sportsman;... but what beside safety they got by sailing in the middle of Walden I do not know, unless they love its water for the same reason that I do.”
—Henry David Thoreau (1817–1862)