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How safe are clinical trials?

November 20, 2008 12:00:00 AM PST
If you're seriously ill, a clinical trial may give you hope. But experts say it's what you don't hear about the trials that you need to worry about. Karen, Joshua and Cyndi are all threatened by a serious illness, but all three were saved by clinical trials.

Not all stories, however, have a happy ending. Less than 5 percent of people in phase-one trials receive any health benefit.

But when a University of Chicago study asked patients why they enrolled, 85 percent said that they were hoping for a cure.

"For every 100 drugs that are out there tested, 70 of them do not work. Another 10 of them hurt people," said Dr. Michael A. Grodin, Boston University.

Federal records show since 1999, at least four people who entered clinical trials in good health died.

"The first and most important thing patients need to be aware of is that clinical trials are not being done for the patient. The researcher is there to gain generalized knowledge. They're not there to benefit you," said Dr. Grodin.

We asked doctors what are the critical questions people need to ask before joining a clinical trial.

"They need to know why they are being approached and what the goals are. They need to know what the purpose is of the research, and then what the risks, benefits, and alternatives are," said Dr. Grodin.

On average, 20 drugs make it from the clinical trial to the pharmacy each year. Not a lot of new drugs, but they can pack a powerful impact for people they save.

While some are fortunate to help pioneer a breakthrough, never forget progress in science almost always involves sacrifice.


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