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On Health: Be Aware of Risks in Drugs' Clinical Trials

Posted - Jul. 31, 2003 at 7:40 a.m.



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Wanted: human guinea pigs.

When people consider participating in studies of new drugs, they often feel they are acting as the human equivalent of test animals.

Well, they are. But researchers, concerned that 80 percent of these studies - known as clinical trials - are delayed beyond their target dates for completion, want would-be participants to know that without their help, and the new drugs and devices that are developed, advancements in disease treatment won't occur.

We all want new and better treatment for diseases and disorders, but not all of us want to put our bodies on the line to achieve that goal. And those of us who do - the average participant is a 58-year- old man - might not reflect enough of the population to ensure that new drugs have broad effectiveness.

Members of the Association of Clinical Research Professionals, a 27-year-old Virginia-based organization of those who run and develop clinical research trials, are beating the drums for patient education.

Diana Anderson, chairman of the group, is a nurse who says she remembers when treatment for the pain of rheumatoid arthritis was mostly morphine. Today, thanks to new drugs developed through clinical trials, there are much improved treatments that stop symptoms and even halt progression of the disease.

But drug trials carry risks that can range from a sick person having to forgo medications however temporarily, to unpleasant side effects, to death. Despite safeguards mandated by the federal government, and review boards whose members are supposed to track trials to ensure safety, patients have died undergoing these experiments.

CenterWatch, a monitoring group, (www.centerwatch.com) estimates that one out of 30 patients will experience a serious side effect during a trial and one in 10,000 will die.

To avoid that guinea pig feeling, Anderson says prospective patients need to be satisfied they are fully informed of the risks and rewards before they sign the necessary informed consent papers that are given to all participants.

"Ask questions. About the status of the physicians conducting the trials. Have they had violations? How long have they been conducting trials?" she suggests.

Information sheets she hands out also include these questions:

- Ask the purpose of the trial, who will benefit from it, how long it will last, how it will affect daily life, can you back out and at what expense, what medications that you are taking might you have to give up, what money will you be paid or what might the trial cost you.

- Also, what treatments will be used, what procedures done, how will patient safety be monitored, who has reviewed and approved the study, who is the contact if you experience adverse effects.

Many patients can find clinical trials advertising for participants in newspaper ads, or may be referred by their doctors.

But no one, no one, should take part in a drug experiment without being fully aware of the risks and benefits and without reasonable certainty that this will be a positive experience.

On Health is a weekly column on health issues. If you have questions or comments, write Carolyn Susman at The Palm Beach Post, P.O. Box 24700, West Palm Beach, Fla. 33416, call 820-4433 or e- mail

(C) 2003 The Palm Beach Post. via ProQuest Information and Learning Company; All Rights Reserved

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