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:
“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)
“The high sentiments always win in the end, the leaders who offer blood, toil, tears and sweat always get more out of their followers than those who offer safety and a good time. When it comes to the pinch, human beings are heroic.”
—George Orwell (1903–1950)
“Man gives every reason for his conduct save one, every excuse for his crimes save one, every plea for his safety save one; and that one is his cowardice.”
—George Bernard Shaw (1856–1950)