Clinical Research Helping Find Cancer Cure

from Children's Magazine, Winter 2004

The Clinical Research Department is (front row, left
to right): Barb Shepperd, RN, CCRP; Deb Schissel,
RN, CCRP; Nancy Kipke, MLT, CMT, CRA; and (back
row): Elaine Hild, RN, BSN; Marilyn Blake, CCRP;
Catherine McKenna, CRA; and Rebecca Kissane,
CCRP.

Children who participate in clinical trials have better survival rates than children who don’t participate in such trials, said Edythe Albano, MD, director of clinical oncology at The Children’s Hospital.

That’s what makes Children’s Clinical Oncology, Neuro-Oncology, BMT and Experimental Therapeutics Research Department, part of the Cancer Center , such an important part of the hospital. Children’s involvement in clinical trials – studies that determine if new drugs or treatments are safe and effective – is crucial to understanding diseases and developing ways to prevent or treat them. Children’s currently is participating in 50 clinical trials for cancer, funded by grants, pharmaceutical companies and the National Childhood Cancer Foundation, said Clinical Research Associate (CRA) Barb Shepperd.           

The majority of children’s hospitals in the nation, including Children’s, are affiliated with the Children’s Oncology Group (COG), an international organization that performs research and clinical trials.

COG provides participating institutions a listing of current trials, Shepperd said. A committee at the University of Colorado Health Sciences Center (UCHSC) and a Colorado board review and approve trials. Then Children’s physicians and the clinical research department decide which trials best serve the children of the Rocky Mountain region, said Rebecca Kissane, a CRA for neuro-oncology and BMT trials.

To be enrolled in a trial, patients and families must agree to participate, and the patient must fit specific eligibility requirements, Shepperd said.

Clinical trials have treatment plans called protocols, said CRA Marilyn Blake. All patients on the trial at all institutions must have received the same treatment. Clinical trial protocols for children often are more aggressive than adult protocols, with higher dosages of chemo drugs and steroids, Dr. Albano said.

Data is submitted and analyzed throughout the study. Once a trial is complete, Shepperd said, statisticians analyze data and decide which protocol was best for a specific disease. That therapy then becomes the standard treatment for children with that disease.

Over the years, clinical trials have made tremendous strides in improving outcomes for children with cancer, Dr. Albano said.

“Childrens’ survival rates correlate with the level of participation in clinical trials,” she said.

Younger children are much more likely to be enrolled in clinical trials, she said, and research shows that younger children have better outcomes. For example, Dr. Albano said, 60 percent of infants to children 4 years old with cancer are enrolled in clinical trials worldwide, as opposed to just 10 percent of adolescents 15 to 19 years old. Also, she said, just 22 percent of 15- to 19-year-olds are treated in pediatric facilities such as a children’s hospital or even at an adult hospital that participates in clinical trials.

“There’s a lack of improvement in young adolescents and adults as compared to younger children and it appears to be directly related to enrollment in clinical trials,” she said.

To decrease the disparity, she said, Children’s is opening more clinical trials to older adults; there’s even a trial for adults up to age 50.

“Literature supports that it’s better for a 16-year-old to come to Children’s for treatment than an adult hospital,” Dr. Albano said. “Children’s has the expertise and the track record for improving the cure – it’s part of the package when you come here.”