More than 24 years ago, Victoria Pemberton, RN, prematurely gave birth to a son with significant health issues. After his health continued to fail while he was on a ventilator, she agreed to enroll him in a clinical trial of a new drug for preemies.
By signing on to the trial, Pemberton felt she was taking positive action to help her son survive with an optimal quality of life.
The clinical trial was a success, leading to the establishment of surfactants, which help critically ill neonates survive despite immature lungs. Actually, her son was assigned to the control group and didn't receive the investigational drug. Fortunately, he is alive and well today.
Pemberton has since devoted her life to medical research in children as a dedicated clinical trials specialist and pediatric heart network coordinator at the National Heart, Lung, and Blood Institute in Rockville, MD, which is part of the National Institutes of Health (NIH).
And thanks to the efforts of Pemberton and colleagues, parents now have access to No More Hand-Me-Down Research, an innovative Web site with text, video clips and Q&A sections to answer their questions about medical research in children.
The Web site describes why research in children is important, how studies are conducted and what measures are taken to protect the safety and privacy of the children enrolled in the studies.
Pemberton speaks in several of the videos on the Web site and explains why it's important to educate and support parents with statements such as "the family can be very affected by enrolling into a clinical trial" and "it becomes what we call a 'family activity.'"
An Excellent Resource
Pediatric nurse practitioner Christine Szychlinski, manager of the food allergy program at Children's Memorial Hospital in Chicago, values credible online sources.
"Since we're so active in research here at Children's Memorial, I spend a lot of time educating parents about research in children," she said. "I like to send parents to objective, knowledgeable sources to reinforce what I've told them, and the NIH Web site is definitely one I'll share with them. It's a great use of our tax dollars."
Szychlinski sees many parents hesitate, understandably, when deciding whether to enroll their children in a medical research study.
"But this site presents the topic in such a way that they'll be able to understand the necessity of clinical trials for kids," she said. "The experience we've had in terms of recalls of cough and cold medications for younger children is yet another reminder that we can't take adult studies and pare them down for children. We need specific research in children to find out if and how specific drugs work, and sites like this get that point across quite clearly."
Szychlinski is evaluating where to include references to the Web site within educational materials given to parents at the hospital.
"We can let parents know, 'If you have additional questions about research in children, here's a trusted NIH site; go there and see what you think,'" she remarked.
Renee R. Jenkins, MD, president of the American Academy of Pediatrics and professor of pediatrics and child health at Howard University College of Medicine in Washington, D.C., said medical research trials involving children are needed because they are not little adults, but rather individuals whose brains and bodies are still developing.
"A good example of their unique research needs is [gaining] understanding of how medications affect the developing child and adolescent," she said. "And clinical trials are the best way to do that."
Kathleen Adlard, an oncology clinical nurse specialist at Children's Hospital of Orange County in Orange, Calif., is proud CHOC is a CureSearch National Childhood Cancer Foundation Children's Oncology Group (COG) member institution and participates in Phase I clinical trials in children.
"Once a medication has been tested in animals and then adults, COG Phase I studies are needed to establish maximum tolerated doses and determine dose-limiting toxicities in children," she explained.