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Clinical Studies and Kids

If your child's physician suggested enrolling your kid in a clinical study, would you know what to say?

A new Web site launched by the National Institutes of Health makes a good case for conducting medical research with children and answers any question that could possibly pop into a parent's mind.

The need for clinical testing involving children under 18 is acute: Most of the drugs and devices used to treat kids have never been tested on them. In most cases, it's been assumed that the treatment tested on adults will work the same way in children; the site refers to these as "hand-me-down" treatments.

Sometimes doses are adjusted for a child's smaller body, but differences in the way kids metabolize drugs aren't always taken into account. (It turns out that sometimes tiny folk need bigger doses, not smaller ones, because of the way their bodies process medication.) Nor are the varying needs of their developing bones, muscles, organs, and neurological systems. When you think about it, it's a big leap, assuming a grownup's drug will work, and work safely, for a kid.

We've seen the fruit of this situation in the recent confusion over the use of cough and cold remedies in children. Are they safe for kids under 6? Under 2? And do they even actually help kids get well? We simply don't know, because these products haven't been tested in kids.

Cold remedies are one thing. How about drugs to treat major diseases like cancer? Multiple sclerosis? Diabetes? The stakes are higher when the condition is life-threatening and the drugs in question highly potent: testing them on specific populations whose bodies are likely to respond differently clearly makes sense.

Children who are ill may benefit from cutting-edge treatments they can get only through participation in research. Even if they don't end up benefiting directly, they and their parents, as the site notes, may take pride in having helped bring about better treatment for other kids in the future.

But despite the many safeguards built into clinical research, participation has inherent risks. A drug being tested might turn out to have serious side effects. Taking part in the study of one drug might block a kid's access to another, potentially better drug. These risks are discussed on the site, and parents are offered guidance in sorting them out.

Of course the NIH is all in favor of clinical research -- funding such studies is its major reason for being. And while the site looks very straightforward, it struck me as perhaps arguing a bit too strongly in favor of kids' participation in research, almost as though taking part is like joining a club.

But a conversation with Victoria Pemberton, a clinical trials specialist with the National Heart, Lung and Blood Institute (NHLBI) and one of the site's creators, helped me set that concern aside.

Pemberton, who conceived the site as a means of helping parents make informed decisions about their children's participation in clinical studies, knows whereof she speaks. Twenty-four years ago, she told me, her son was born prematurely and faced grave health risks. When his health continued to fail after he was placed on a ventilator, hospital staff asked whether she would like her baby to participate in a trial of a new drug developed just for premature infants.

Pemberton figured the trial was her only chance for a healthy baby: there was no way for him to get this treatment without joining the trial. And by signing on to the study, she felt like she was taking some positive action on his behalf -- since children in clinical studies are afforded extra, and extra careful, attention by medical personnel.

The drug in question, the first in the class known as surfactants, has become a mainstay of care for critically ill premature babies. Pemberton's son is all grown up now and, despite some health problems, doing well. Does he owe his survival to his participation in the trial?

Hard to say. See, while she remains convinced that enrolling her baby was the right thing to do, he ended up in the control group -- the one receiving a placebo, not the new medication.

Have you had to make a decision about your child's participation in clinical research? Where did you turn for information and guidance? How did things turn out? Any regrets?

By Jennifer LaRue Huget  |  October 29, 2008; 7:00 AM ET
Categories:  Family Health  
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I think it's important to remember that in a clinical trial the patient always receives treatment equal to the prevailing standard of care.

In your example of the baby, he may have been randomized into the placebo group, but at that time no special drug/treatment was the standard of care.

A parent may worry that if they participate in a trial that their child will not receive treatment, and that is not true. It's the accepted standard of care OR the trial treatment.

Also, clinical trials are not limited to just trials of new drugs. Sometimes they are studying sequences or combinations of treatments. So you child isn't necessarily being given drugs that are un-proven, they may be receiving existing drugs or treatments in different combinations or dosages.

Posted by: RedBird27 | October 29, 2008 9:56 AM | Report abuse

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