Special Segment: Hoping for a breakthrough

November 27, 2008 9:12:00 PM PST
There are 40,000 clinical trials going on in the United States right now, and more than a million people are taking part.All of them hope for a discovery that will save their lives and the lives of others, but is the risk worth it?

Karen, Joshua and Cyndi are three people whose lives are threatened by serious illness.

"I was diagnosed originally with lymphoma, and it didn't look very promising," said Karen.

"I noticed his heart was racing a little more. He was breathing 100 times per minute," Joshua's doctor said.

"Two or three times a week, I was having low sugars. They put me on a bunch of IVs," Cyndi said.

All three of their lives were saved by clinical trials.

"Unbelievable. I really truly am a miracle," Karen Degray said.

But not all stories have a happy ending. Less than five-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 were hoping to be cured.

"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 of 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," said Grodin.

According to CenterWatch, trials happen in phases. Phase one uses a small group of, perhaps, 20 people. Researchers evaluate safety, dosage and side effects.

"One potential side effect is death," said Duke Clinical Research Institute's Kevin Weinfurt, PhD.

Phase two involves about 80 people. The goal is to determine effectiveness and measure side effects. Phase three involves 1,000 or more people for longer periods of time. Phase four trials are post-marketing studies confirming risks and benefits.

"The researcher is there to gain generalized knowledge. They're not there to benefit you," said Grodin.

ABC7 Chicago 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, what the goals are, what the purpose is of the research, and then what the risks, the benefits and the alternatives are," Grodin said.

"How is participating in this study different that if you were providing regular care?" said Weinfurt.

One of the most important questions to ask is will there be a placebo group? If that's the case, that means no one in the trial will know if they're getting the real drug or a fake.

"It's going to be a coin toss, and so you want to be very careful about that when there is a placebo group involved," Weinfurt said.

CenterWatch reports that, 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.

"I'm just happy to be alive," Degray said.

For each life saved, there are thousands more waiting and wondering if medicine will make it in time for them.

For more information about all ongoing clinical trials, visit:

http://clinicaltrials.gov/ and http://www.cancer.gov/CLINICALTRIALS


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