Improving informed consent for children in cancer treatment studies

Cleveland, Ohio: A study at six of the nation's leading children's hospitals has concluded that physicians should do a better job in communicating with parents before a child with cancer enrolls in a randomized clinical trial. "Our findings demonstrate that common strategies to explain the concept of randomization to patient families are not effective," explains Eric Kodish, MD, lead author of the study published in the Journal of the American Medical Association (JAMA, 1/28/04). Dr. Kodish is a pediatric oncologist and director of the Rainbow Center for Pediatric Ethics at Rainbow Babies & Children's Hospital in Cleveland, and professor of pediatrics at Case Western Reserve University School of Medicine.

The research also involved a Parent Advisory Group to help in the study design and analysis, with parents representing all the study sites, including: Rainbow; Children's Hospital Medical Center, Cincinnati, OH; Children's Hospital Los Angeles, CA; Children's Hospital of Philadelphia, PA; Children's National Medical Center in Washington, DC; and the MD Anderson Cancer Center in Houston, TX. The study was supported by the National Institutes of Health and the Children's Oncology Group, a network of pediatric medical centers.

As part of the study, researchers observed and audiotaped the informed consent conferences involving 137 families at the six medical centers from July 1, 1999 to December 31, 2001. The patients were children, all newly diagnosed with acute leukemia. Childhood cancer treatment commonly involves the option of participation in clinical trials, which have revolutionized pediatric cancer treatment and significantly improved outcomes. In fact, the authors note that: "Thousands of children with cancer have been enrolled in randomized clinical trials over the past 40 years. The cure of childhood leukemia, one of the great success stories of modern medicine, has been a direct result of these trials."

In every case confer

Contact: Eileen Korey
University Hospitals of Cleveland

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