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:
“To emancipate [the slaves] entirely throughout the Union cannot, I conceive, be thought of, consistently with the safety of the country.”
—Frances Trollope (1780–1863)
“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)
“[As teenager], the trauma of near-misses and almost- consequences usually brings us to our senses. We finally come down someplace between our parents’ safety advice, which underestimates our ability, and our own unreasonable disregard for safety, which is our childlike wish for invulnerability. Our definition of acceptable risk becomes a product of our own experience.”
—Roger Gould (20th century)