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:
“Can we not teach children, even as we protect them from victimization, that for them to become victimizers constitutes the greatest peril of all, specifically the sacrifice—physical or psychological—of the well-being of other people? And that destroying the life or safety of other people, through teasing, bullying, hitting or otherwise, “putting them down,” is as destructive to themselves as to their victims.”
—Lewis P. Lipsitt (20th century)
“There is always safety in valor.”
—Ralph Waldo Emerson (1803–1882)
“A lover is never a completely self-reliant person viewing the world through his own eyes, but a hostage to a certain delusion. He becomes a perjurer, all his thoughts and emotions being directed with reference, not to an accurate and just appraisal of the real world but rather to the safety and exaltation of his loved one, and the madness with which he pursues her, transmogrifying his attention, blinds him like a victim.”
—Alexander Theroux (b. 1940)