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No Guinea Pigs Here

Web site, nurses help parents understand pediatric clinical trials

Monday March 9, 2009
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Pediatric medical research studies can result in a host of important benefits, yet many parents remain reluctant to involve their children. The National Heart, Lung, and Blood Institute hopes its new Web site will help parents — and healthcare providers — learn more about pediatric clinical trials.

The site (www.nhlbi.nih.gov/ChildrenAndClinicalStudies) features a 10-minute video in which kids with medical conditions, their parents, physicians, and nurses talk about what is involved in clinical trials and why these trials are important. Other links offer information about how to join a study, parents' and children's rights, and common terms associated with clinical studies.

The information strives to present a balanced viewpoint, says Victoria Pemberton, RNC, MS, CCRC, a clinical trials specialist with NHLBI. "The site isn't all 'Rah, rah, join our clinical trials,' " she says. "It's about empowering parents, encouraging them to ask questions, and helping them find good resources for information."

Nurses' Opinions Count

Because nurses often develop a close bond with patients and their families, their opinions can strongly influence a family's decision to allow a child to participate in a clinical research project, Pemberton says. That's why it is important for nurses to be well-informed about clinical trials with children and where to direct families to find reliable sources of information.

Researchers face many challenges when it comes to clinical studies on young people. Regulations vary by state and even between institutions, says Pemberton. In addition, there can be confusion about how institutional review boards interpret the FDA's Codes of Federal Regulation, which help define what kinds of research can and cannot be performed with children.

Making parents aware of clinical trials in their regions also can be problematic. Healthcare providers see only a small percentage of patients who might be eligible for studies, so the search continues for better ways to get the word out. The belief is that a lot of potentially willing patients remain untapped, simply because there's no effective way to let parents know clinical studies are being conducted.

Debunking Misconceptions

But even when parents are aware of trials, a host of misconceptions might prevent them from enrolling their children, says Julie Denlinger, RN, BSN, a research nurse at Cincinnati Children's Hospital Medical Center. "One of the biggest misconceptions among parents is that their children are guinea pigs, that researchers are just testing new drugs on their kids," Denlinger says. "They often don't understand just how involved clinical studies are."

Another common fallacy, she says, is that research facilities and pharmaceutical companies are in it just for the money. "Parents forget that these institutions are really trying to improve the health of children," she says.

Reluctance among parents to participate in clinical trials is understandable in light of the controversy regarding the use of cough and cold medicines in young children. In 2007, a panel of government advisers discouraged the use of popular OTC cold and cough remedies for children age 2 to 5, concluding that cold medicines have no effective use in children. In addition, reports of potentially dangerous side effects led drugmakers to stop marketing cold and cough medicines for use in children younger than 2.

This news only enhanced parental fears and animosity toward drugmakers. Worries about dangerous side effects or potential harm from common medications keep many parents from enlisting their children in clinical trials.

But Michael Spigarelli, MD, PhD, director of clinical trials at Cincinnati Children's Hospital Medical Center, says the well-publicized episode illustrates the need for more clinical trials because the majority of medications used in the U.S. have not been tested on children.

Legislative Support

But there have been efforts to change that. In 1997, for example, Congress passed the FDA Modernization Act, which provides six additional months of market exclusivity to drug manufacturers who voluntarily conduct drug studies on children. That was followed in 2002 with the Best Pharmaceuticals for Children Act, which was renewed in 2007.

"It's been a remarkable success," says Spigarelli. "Since 2002, more than 145 different drugs have had their labeling changed after being tested in children. In the 11 years prior to that, between seven and 11 drug labels included information on usage in children."

Ethical Concerns

Pharmaceutical issues are just one example of why more pediatric clinical trials are needed, say advocates. Equally important is the study of certain diseases, such as rheumatoid arthritis, which present differently in children and adults. "If we don't study those things in children," Pemberton says, "we may never know how treatments or drugs or devices affect them."

It's difficult to discuss clinical trials in children without addressing the related ethical issues. Of particular concern are the concepts of assent and consent.

Ideally, researchers say everyone involved in a clinical trial should understand what the study involves, what it hopes to achieve, the potential dangers/side effects, and other issues. But that's not always possible. A competent 16-year-old, for example, can understand all of these things, Spigarelli says, but the issue becomes fuzzier when studies involve children who are too young to understand or children with conditions, such as Down syndrome or autism, that limit their ability to make decisions.

"The ethical consideration becomes the balance of the right of participants to be treated fairly, with their guardians' understanding the risks and benefits, realistically coupled by the right of society to have drugs tested to make sure they are safe for everybody," he says.

Spigarelli, Pemberton, and Denlinger are advocates for clinical studies on children. Each has involved his or her own children in various trials.

"I think we would be very bad if we didn't let our kids participate in research studies while asking other people to let their children," Spigarelli says. "If the people doing research don't believe in its importance and safety, that's a problem."


Don Vaughan is a freelance writer.To comment, e-mail editorMW@NursingSpectrum.com.