Patients Cut From Drug Trials
December 12, 2003
What happens to patients when a drug trial ends is one of the most ambiguous aspects of medical research. There are no government rules mandating that someone who is doing well on an experimental medicine must keep receiving treatment.
Yet companies need patients willing to try unproven drugs. And because of the way these trials are structured, there is no guarantee that a person will continue receiving a new medication even if it is helping them.
In recent decades, however, the number of drugs being tested and patients participating in clinical trials has soared:
- In 2002, the Food and Drug Administration (FDA) reported receiving 2,734 applications to test drugs in clinical trials, up from 1,596 in 1986.
- Because each drug typically goes through least three separate trials, there are tens of thousands of patients in such tests every year.
- Small trials can cost millions and larger ones may run up to $100 million; in addition, the majority of drugs tested in clinical trials fail and, as a result, many companies make only make enough trials of the drug for testing.
- Also, if a person who does well in a trial continues on a medicine and later has a bad side effect, the company is required to report it to the FDA; companies and researchers worry the FDA could ask questions or even suspend a drug development program if serious concerns about safety arise.
Source: Geeta Anand, "How Some Patients in New-Drug Trials Can Get Cut Off," Wall Street Journal, December 8, 2003.
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