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:
“The Declaration [of Independence] was not a protest against government, but against the excess of government. It prescribed the proper role of government, to secure the rights of individuals and to effect their safety and happiness. In modern society, no individual can do this alone. So government is not a necessary evil but a necessary good.”
—Gerald R. Ford (b. 1913)
“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)
“Perhaps having built a barricade when you’re sixteen provides you with a sort of safety rail. If you’ve once taken part in building one, even inadvertently, doesn’t its usually latent image reappear like a warning signal whenever you’re tempted to join the police, or support any manifestation of Law and Order?”
—Jean Genet (1910–1986)